louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03488043: Predictive Score of PneumOThorax Secondary to CT-guided Transthoracic Lung Biopsy Made From a Large Retrospective Cohort and Validated on a Prospective Cohort
Official title: Predictive Score of PneumOThorax Secondary to CT-guided Transthoracic Lung Biopsy Made From a Large Retrospective Cohort and Validated on a Prospective Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumothorax
Keywords: Lung lesions
Pneumothorax
CT-guided transthoracic biopsy
Risk score
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See eligibilty criteria

Brief summary: Transthoracic lung biopsy (TLB) provides a histological diagnosis of nodule or lung mass. Pneumothorax is the main complication of TLB with an average of 20%. Many risk factors, whether clinical, computed tomography or related to TLB, are described in the literature. The British Thoracic Society recommends monitoring for 2 hours after the procedure with a possible discharge if the chest X-ray is normal. There is no French or European recommendation for monitoring the occurrence of pneumothorax after TLB. In the university center of Besançon, France, a minimum supervision of 4 hours is recommended and approximately one in two patients is hospitalized until the following day to reach this minimum time of 4 hours. The objective of the SPOT study is to perform a predictive score of pneumothorax from a retrospective cohort of patients for whom a transthoracic lung biopsy was performed and to validate this score on a prospective cohort. The expected goal is to select patients who can benefit from outpatient care by shortening the post-procedure surveillance period and to monitor more long-term only high-risk patients.


Eligibility criteria: Inclusion Criteria:

* Patients having needle lung biopsy CT-guided for diagnostic purposes.

Exclusion Criteria:

* Nodule or mass in contact with the pleura for which the aerated pulmonary parenchyma is not crossed by the puncture needle.
* Several pulmonary sites biopsied.
* Existence of a pneumothorax before procedure
* Per-procedural appearance of alveolar or interstitial pneumonitis at the level of the biopsy area.
* Cavitary aspect of nodule or mass
* Absence of chest X-ray control
* Poorness quality of chest X-ray control

Primary outcomes:
measure: Pneumothorax occurrence
timeFrame: between 4 and 24 hours after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
state: Doubs
Study officials:
References:
Clinical trial NCT06115343: Conscious Awareness Practice in Adolescents
Official title: Consciousness in Adolescents The Effect of Awareness Practice on Self-Efficacy and Risky Behaviors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Risky Behavior
Keywords: Conscious Awareness
Self-Efficacy
adolescent
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to reveal the effect of mindfulness on self-efficacy and risky behaviors in adolescents.

Detailed description: This randomized controlled experimental study was carried out between 18 September and 27 October at Istanbul Bağcılar Necmettin Erbakan Science High School with a total of 60 students (30 experimental group / 30 control group). Research data were collected from the Conscious Awareness-Based Self-Efficacy Scale-Revised (BFÖS-Y), Risky Behaviors Scale (RDS) and Personal Information Form. Ethics committee approval, written institutional permission and written permission from the participants were obtained for the research. In the first week, pre-tests were given to the experimental and control groups, and the experimental group was given 30 minutes of mindfulness training. Mindfulness training continued to be given to the experimental group for the next 5 weeks, and post-tests were given to the experimental and control groups in the last week.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 14 and 18
* Agree to participate in the study
* Being literate and speaking Turkish fluently
* Have communication and understanding skills

Exclusion Criteria:

* Having a physical health problem that may impair group cohesion and integrity

Primary outcomes:
measure: Change in The Effect of Mindfulness Training on Self-Efficacy in Adolescents.
timeFrame: [Time Frame: up to 6 weeks]
measure: Change in The Impact of The Functioning of Detention Education in Adolescents.
timeFrame: [Time Frame: up to 6 weeks]
Secondary outcomes:
Other outcomes:
Locations:
city: Osmaniye
country: Turkey
facility: Korkut Ata University
state: Center
Study officials:
affiliation: pskdan.yunusomerarik@gmail.com
name: Yunus Ömer ARIK, Teacher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06311643: Ameliorative Potential of Relaxing Back Massage on Puerperial Women's Hormones and Infant Weight
Official title: Ameliorative Potential of Relaxing Back Massage on Puerperial Women's Hormones and Infant Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Does Postpartum Massage Affect Leptin, Prolactin and Growth Hormone
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 45
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Puerperal woman aged from 25 to 30 years within 4 hours of normal delivery
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Effect of massage on hormone levels in puerperal women

Detailed description: Postpartum back massage can effectively increase prolactin, growth hormone levels, which in turn can make the baby's growth more healthy and decrease leptin levels, which can protect the child from future obesity and so, clinicians should advise postpartum women to have massage after delivery.

Eligibility criteria: Inclusion Criteria:

* puerperal women within 4 hours of normal delivery and they are primiparous

Exclusion Criteria:

* nulliparous More than 30 years or less than 25 years Chronic diseases Caesarean delivery

Primary outcomes:
measure: Leptin and prolactin levels increase
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kafrelshiekh
country: Egypt
facility: Kafrelshiekh university
Study officials:
References:
Clinical trial NCT03670043: Tolerance & Responsiveness Improvement for Metformin (TRIM)
Official title: Tolerance & Responsiveness Improvement for Metformin (TRIM): Open-label, Parallel-group Randomized Trial, Phase 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type2 Diabetes Mellitus
Lead sponsor: West Side Institute for Science and Education
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 29
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal is to explore the hypothesis that prebiotic fiber Psyllium will ameliorate diarrhea in African American men (AAM) with Type2 Diabetes Mellitus (T2D).


Eligibility criteria: Inclusion criteria

1. Male (M)
2. African American (AA) race
3. Age 20-70 years
4. BMI 28-59 kg/m2
5. T2D
6. A1c 6.5 - 8.9%
7. eGFR =/\> 30
8. Drug-naïve or use Glipizide or newly started on Metformin (within 2 weeks).

Exclusion criteria

1. Chronic kidney disease stage 3b, 4 and 5 (eGFR \< 30)
2. Insulin use
3. Oral steroids use (inhalers and creams are allowed)
4. Antibiotic use within the last month
5. Artificial heart valves
6. Hospitalization for chronic condition within 6 months prior to the study
7. History, manifestations or medications of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric/ psychological disorders, or social circumstances which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject.
8. Use of other antidiabetic drugs (except glipizide and metformin).
9. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

Additional Exclusion criteria for subjects who previously used Metformin:

1. Previous severe allergic reaction to metformin hydrochloride, such as angioedema.
2. Previous Metformin intolerance causing significant diarrhea or GI-upset. Would not exclude participants who had history of mild diarrhea with metformin use.
3. Previous side effects that the subject feels were related to Metformin and the subject is not interested to re-try metformin.

Primary outcomes:
measure: Birmingham Irritable Bowel Syndrome (IBS) Symptom Questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
Study officials:
affiliation: Jesse Brown VA Medical Center
name: Barengolts
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04162743: The Effect of Trazodone on the Severity of Obstructive Sleep Apnea in Insomnic Stroke Patients With Depression
Official title: The Effect of Trazodone on the Severity of Obstructive Sleep Apnea in Insomnic Stroke Patients With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea Syndromes
Cerebral Infarction
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that trazodone does not worse nocturnal oxygen saturation in insomnic ischemic stroke patients with obstructive sleep apnea (OSA) and depression and has beneficial effect in selected stroke patients with low arousal threshold phenotype OSA.


Eligibility criteria: Inclusion Criteria:

* Insomnic ischemic stroke patients with OSA and depression.

Exclusion Criteria:

* unclear consciousness, unstable vital sign or neurologic sign, unstable medical conditions such as delirium, active infection, evidence of overt congestive cardiac failure, liver dysfunction with ascites, thyroid disease, end-stage-renal-disease receiving dialysis.
* overnight mean oxygen saturation (SaO2) nadir is ≤ 70% at baseline
* take monoamine oxidase inhibitors (MAOI), any medication that may affect breathing, sleep, or muscle activity
* any known allergy to trazodone
* sleep disorder other than OSA (e.g., periodic leg movement syndrome, restless legs syndrome, central sleep apnea/Cheyne-Stokes respiration).

Primary outcomes:
measure: nocturnal oxygen saturation
timeFrame: the polysomnography study night before take drug
measure: Sleep apnea severity index
timeFrame: the polysomnography study night before take drug
Secondary outcomes:
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital, Keelung
Study officials:
References:
citation: Chen CY, Chen CL, Yu CC. Trazodone improves obstructive sleep apnea after ischemic stroke: a randomized, double-blind, placebo-controlled, crossover pilot study. J Neurol. 2021 Aug;268(8):2951-2960. doi: 10.1007/s00415-021-10480-2. Epub 2021 Feb 24.
Clinical trial NCT02537743: Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced Renal Cell Carcinoma
Official title: Open-labeled, Multicenter, Non-interventional, Prospective PRO Registry for Patients With First Line Treatment for Advanced RCC Using a Tablet-technology Based Digital Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Patient Reported Outcomes
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with advanced (inoperable or metastatic) renal cell cancer at the start of the first line antitumoral therapy

Brief summary: Evaluation of patient reported outcomes ( PRO) regarding typical ailments in the REAL LIFE Renal Cell Carcinoma population

Detailed description: The PRO Kidney project will recruit a representative cohort of patients with advanced renal cell carcinoma (RCC) treated with systemic antiproliferative therapies such as TKIs, mTOR inhibitors, cytokines, antiVEGF or immune therapy. The aim of this study is to collect data on the effectiveness and patients´quality of life on preference in the real life setting.

Patient Reported Outcomes ( PRO) are assessed by a questionnaire consisting Functional Assessment of Cancer Therapy ( FACT) Kidney Syndrome Index 19 (FKSI 19) completed by four questions assessing ailments about changes in skin of hands/feet, taste, color of hair and mouth scores.

13 Questions about Fatigue assessed with the Functional Assessment of Chronic IIlness Disease.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed renal cell carcinoma
* Start of the first line systemic treatment
* Ability to read and understand German
* Written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Primary Outcome Measure (Patient Reported Outcomes (PRO) regarding typical ailments in the real Life RCC population)
timeFrame: 24 months
Secondary outcomes:
measure: Secondary Outcome Measures (Patient Reported Outcomes (PRO) regarding the impact of treatment on daily life)
timeFrame: 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Multiple sites all over Germany
Study officials:
affiliation: medical practise for oncology
name: Tilman Kirste, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05785143: Timing of Damage Control Orthopedic Surgery
Official title: Utilizing Dry Lab Database to Analyze the Prognostic Factors of Multi-trauma Patients and Determine the Optimal Timing of Definitive Orthopedic Operation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: The Precision Personal Timeline in Definitive Surgery Associated With Outcome
Keywords: multi-trauma
lactate
definitive orthopedic operation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pelvic fracture patients

Brief summary: The decision to operate and surgical timing on multi-trauma patients remains controversial, inappropriate surgical timing may cause more complications which lead to poor prognosis. We hope to find out the connection between lactate and prognosis in multi-trauma patients, and the optimal timing of definitive treatment.

Detailed description: The decision to operate and surgical timing on multi-trauma patients remains controversial, inappropriate surgical timing may cause more complications which lead to poor prognosis.

The aim of our study is to analyze if serum lactate a predictive factor of optimal surgical timing in multi-trauma patients. In order to obtain more accurate data, we choose to utilize ili database and trauma database instead of National Health Insurance Research Database.

Multi-trauma patients from 2002 through 2022 were included to our study. We hope to find out the connection between lactate and prognosis in multi-trauma patients, and the optimal timing of definitive treatment.

Eligibility criteria: Inclusion Criteria:

* (1) Injury severity score(ISS) \> 16 with pelvicfracture or long bone fracture requiring surgical fixation (2) Patient age ≥ 20. Pathologic fracture was excluded. Our primary endpoint si mortality rate, secondary endpoints include ICU stay, ICU complications (Sepsis, Pneumonia, Multiple organ failure)

Exclusion Criteria:

* death before into undergoing surgery

Primary outcomes:
measure: EQ5D5L
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: North District
Study officials:
References:
Clinical trial NCT02292043: Effects of HTEA ON Heart Failure Secondary to Idiopathic Dilated Cardiomyopathy or Post-myocardial Infarction
Official title: Effects of HTEA ON Heart Failure Secondary to Idiopathic Dilated Cardiomyopathy or Post-myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congestive Heart Failure
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: heart failure.

Brief summary: The investigators would evaluate the effects of the novel method, HTEA on cardiac function in the heart failure patients secondary to idiopathic dilated cardiomyopathy and post-myocardial infarction.

Detailed description: The investigators would evaluate the effects of the novel method, HTEA on cardiac function in the heart failure patients secondary to idiopathic dilated cardiomyopathy and post-myocardial infarction. The specific index is 6 miniutes walk distance, echocardiography, NYHA, NTproBNP level, peripherial WBC, RBC, PLT, Cre, UA, K+, Na+ upon entrance to hospital and 4 weeks after HTEA treatment, and 3 months after discharge. The morbidity and re-hospitalization would also calculated 3 months after discharge.

Eligibility criteria: Inclusion Criteria:

* 90 chronic cardiac failure patients in our hospital were selected and divided into two groups.

Exclusion Criteria:

* Vavular diseases

Primary outcomes:
measure: Morbidity
timeFrame: 1 months to 3 months after discharge
Secondary outcomes:
measure: The decreased degree of NT-proBNP higher than 30%
timeFrame: 3 months after discharge
Other outcomes:
Locations:
city: Harbin
country: China
facility: Ren Xiaohui
state: Heilongjiang
city: Harbin
country: China
facility: the first affiliated hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: wei liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04193943: Validation of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy
Official title: Validation Study of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness Polyneuropathy
Critical Illness Myopathy
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 130
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: Critically Ill Patients

Brief summary: Evaluate the accuracy, in the diagnosis of critical illness myopathy and / or neuropathy, of the simplified peroneal nerve test performed by a neurophysiopathology technician or by a neurophysiopathology doctor (as the gold standard) compared to the exam performed by an intensivist.


Eligibility criteria: Inclusion Criteria:

- adult patients admitted to Intensive care unit

Exclusion Criteria:

* patients in terminal conditions
* patients with peroneal nerve exam not feasible ( for example with presence of prostheses, wounds, plaster casts, edema of the limbs)

Primary outcomes:
measure: sensitivity and specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal
timeFrame: up to the comlpete execution of the two peroneal nerve exams,at most an hour
measure: specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal
timeFrame: up to the comlpete execution of the two peroneal nerve exams, at most an hour
Secondary outcomes:
measure: evaluation of concordance between peroneal nerve test performed by an intensivist compared to peroneal nerve test performed by a neurophysiopathologist considering the test as a continuous variable
timeFrame: up to the comlpete execution of the two peroneal nerve exams, at most an hour
measure: correlation between hospital mortality and abnormal peroneal nerve test
timeFrame: up to hospital discharge, an average of 6 months
measure: correlation between hospital discharge destination and abnormal peroneal nerve test
timeFrame: up to hospital discharge, an average of 6 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Spedali Civili
Study officials:
affiliation: II Servizio di Anestesia e Rianimazone, Spedali Civili
name: Elisa Seghelini
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02457143: Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Clinical Trial
Official title: Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Detection of Cancer
Cancer
Socioeconomic Status
Keywords: recall
income-related disparities
cancer screening
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 5270
Sex: ALL
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This randomized trial aims to understand how effective a reminder letter is compared to a reminder phone call in improving breast, cervical and colorectal cancer screening rates and reducing screening disparities.


Eligibility criteria: Inclusion Criteria:

* The trial will include patients who are rostered to the family practice as of March 31, 2015, are eligible and overdue for cervical, breast and/or colorectal cancer screening and are verified by their primary care physician as needing recall.

Exclusion Criteria:

* Patients will be excluded if their primary care physician noted they should not be recalled for screening or if the patient does not have both an address and a phone number on file.

Primary outcomes:
measure: The proportion of patients in each arm who go on to receive at least one screening test for which they are due
timeFrame: 6 months
measure: The proportion of patients in each arm who are due for breast, cervical and colorectal cancer screening who go on to receive those respective screening tests (female patients may be represented in the outcome calculation of more than one cancer screening
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital Academic Family Health Team
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Aisha Lofters, MD PhD CCFP
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Tara Kiran, MD MSc CCFP
role: PRINCIPAL_INVESTIGATOR
References: