louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01493739: EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy
Official title: EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mediastinal Lymphadenopathy
Lung Cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with mediastinal lymphadenopathy on Chest CT scan with a short-axis \> 10mm

Brief summary: This study aims on the combinatorial results of cytology, histopathology and microbiology obatined by EBUS-TBNA for unselected mediastina lesions.

Detailed description: A number of studies have proved EBUS-TBNA to be useful for lymph node staging in lung cancer. The diagnostic performance is equivalent to mediastinoscopy while the invasiveness is far less. This study primarily focusing on merged approach of cytology, histopathology and microbioloogy obatined by EBUS-TBNA for unselected mediastina lesions.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* mediastinal lymphadenopathy on Chest CT scan
* with a short-axis \> 10mm

Exclusion Criteria:

* patients intolerant to bronchoscopy exam
* unstable vital sign (Blood pressure, heart rate, breath rate)

Primary outcomes:
measure: Diagnostic rate
timeFrame: Participant will be followed within an average of three months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chih-Hso Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03788239: Wound Closure After Total Knee Replacement
Official title: Wound Closure After Total Knee Replacement: Comparison Between Staples and Sutures.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound of Knee
Lead sponsor: Indus Hospital and Health Network
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 211
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the wound healing after total knee replacement wound closure with staples versus subcuticular prolene suture.

Detailed description: .Informed consent will be taken from all the patients who meet the inclusion and exclusion criteria and then will be randomized into one of the two study arms (Arm 1: will undergo wound closure with staples and Arm 2 wound closure with subcuticular prolene suture).

before the start of surgery. The primary investigator will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol i.e. they will be sequentially numbered, opaque sealed envelopes. Before opening the envelope, the primary investigator will write the patient's medical record number, date and will sign the envelope. The envelope will contain carbon paper which will transfer the data allocation paper inside.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary total knee replacements for osteoarthritis or post-traumatic arthritis (diagnosed on X-rays and history)
* Bilateral knee surgeries
* Patients giving informed consent

Exclusion Criteria:

* Patients having previous skin, neuromuscular or connective tissue disorder (confirmed by history)
* Patients taking steroids (confirmed by history)
* Body mass index \> 30 (increases chances of wound dehiscence)
* Lack of consent
* Pregnant females (confirmed by history)

Primary outcomes:
measure: Wound healing
timeFrame: Surgery till 1 year post-op
measure: Complications
timeFrame: Surgery till 1 year post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Indus Hospital
state: Sindh
Study officials:
References:
Clinical trial NCT02232139: Measurement of Psychomotor Recovery After Anesthesia Using 4CRT
Official title: Measurement of Psychomotor Function Recovery in Patients After General Anesthesia Using 4-Choice Reaction Time Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delayed Recovery From Anaesthesia
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Department of Anesthesiology, Hospital Dresden-Friedrichstadt, Dresden, Germany
First posted: 2014-09-05
Enrollment: 124
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test (4CRT) as a measure for recovery of the psychomotor function in patients after general anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in general anesthesia, will be randomized to the group with pharmacological anxiolytic premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients will be monitored using 4CRT before and after standardized general anesthesia. The reaction time, measured with 4CRT is the primary outcome parameter of the investigation.

Detailed description: 4CRT is a classical psychological test, used to measure the psychomotor speed. This test measures choice reaction time. The participants are instructed to respond by pressing the keys 1-4 of the keyboard, corresponding to the numbers, appearing on the screen of computer (PDA, SmartPhone). The average of the response latency, measured during the 10 trials is usually taken as 4CRT outcome.

Eligibility criteria: Inclusion Criteria:

* Physical status I-III according to American Society of Anesthesiology
* ambulatory gynecologic surgery of 10-40 min
* patient is able to use VAS and to use SmartPhone-based 4CRT
* given informed consent

Exclusion Criteria:

* age \< 18 or \> 50 years
* patients who are not able to give their informed consent
* surgery lasts more than 40 min.
* history of psychopharmaceuticals or analgesics

Primary outcomes:
measure: Change of four choice reaction time from baseline
timeFrame: One time before the surgery and 2 hours after the surgery
Secondary outcomes:
measure: Concentration of midazolam in serum
timeFrame: Within 2 hours after the surgery only in 40 (20 from each group) participants
Other outcomes:
measure: Postanesthesia discharge scoring system
timeFrame: Within 2 hours after the surgery
Locations:
city: Dresden
country: Germany
facility: Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy
state: Saxony
Study officials:
affiliation: University Medicine of Greifswald
name: Taras I Usichenko, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Zuurmond WW, Balk VA, van Dis H, van Leeuwen L, Paul EA. Multidimensionality of psychological recovery from anaesthesia. Analysing six recovery tests. Anaesthesia. 1989 Nov;44(11):889-92. doi: 10.1111/j.1365-2044.1989.tb09141.x.
Clinical trial NCT03074539: Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension
Official title: Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension - a Prospective, Descriptive Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Sleep Disordered Breathing
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: There is evidence for a high prevalence of Sleep Disorder Breathing (SDB) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Central Sleep Apnea, Cheyne-Stokes Breathing and Obstructive Sleep Apnea appear to occur in CTEPH. However, there is no information on the impact of CTEPH treatment modalities on concomitant SDB. Furthermore, the use of PAP therapy in CTEPH has not yet been investigated. CTEPH is a rare and serious disease and there may be a bidirectional association of SDB and CTEPH.

This study plans to investigate the prevalence of SDB in CTEPH and compare it to datasets of large epidemiological studies on SDB. Furthermore, the impact of CTEPH treatment on SDB will be analyzed and CTEPH patients for possible PAP treatment will be defined.


Eligibility criteria: Inclusion Criteria:

* Recently diagnosed untreated CTEPH
* NYHA I-III

Exclusion Criteria:

* Age\<18
* Pulmonary Hypertension other than CTEPH
* Previous diagnosis of SDB
* Ongoing PAP treatment
* Use of nasal oxygen

Primary outcomes:
measure: AHI change under CTEPH treatment
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients with persisting elevated AHI (= ≥15/h) after CTEPH treatment
timeFrame: Time point: 6 months after the individual start of the CTEPH treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical Unviersity Vienna
Study officials:
affiliation: Medical University Vienna
name: Irene Lang, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT04604639: Do Patients Suffering a Cardiac Arrest Present to the Ambulance Service With Symptoms in the Preceeding 48hrs?
Official title: Do Patients Suffering an Out-of-hospital Cardiac Arrest Present to the Ambulance Service With Symptoms in the Preceeding 48hrs?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: Cardiac arrest
Ambulance
Triage
Deterioration
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: South Central Ambulance Service NHS Foundation Trust
First posted: 2020-10-27
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients calling for an emergency ambulance in the South Central Ambulance Service region, where an emergency ambulnace was dispatched and a patient intervention occurred.

Brief summary: A cardiac arrest is often preceeded by a varying period of physiological deterioration which if acted upon may prevent the cardiac arrest. We aim to review patients presenting to the ambulance service with cardiac arrest so see if they had contacted the ambulance service in the preceeding 48 hrs to understand if warning symptoms were missed or not acted upon appropriately.

Detailed description: The UK ambulance services are called to attend 60,000 out-of-hospital cardiac arrests (OHCA) each year. Hospital studies have shown that many patients who suffer an in-hospital cardiac arrest (IHCA) have been deteriorating for the preceeding 48 hrs and suggest that many IHCA are potentially avoidable if this deterioration is identified and actued on promptly. No similar study has been performed to see if patients suffering OHCA have also presented with warning signs in the preceeding 48 hrs that were overlooked.

Eligibility criteria: Inclusion Criteria:

• All patients seen by SCAS ambulance crews and suffering a cardiac arrest within the following 48 hrs

Exclusion Criteria:

• None

Primary outcomes:
measure: Out-of-hospital cardiac arrest
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Otterbourne
country: United Kingdom
facility: South Central Ambulance Service
state: Hampshire
Study officials:
affiliation: Divisional Medical Director
name: Charles D Deakin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02652039: Interactionality of Music Preference and Individual Variables in Pain Perception and Management
Official title: Interactionality of State-Trait Music Preference, Individual Variability, and Music Characteristics as a Multi-Axis Paradigm for Context-Specific Pain Perception and Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients

Brief summary: The purposes of this study were 1) to delineate any differences in general musical taste (trait) and context-specific music preference (state), as well as preferred music characteristics in cancer patients, 2) to investigate the contributions of individual variabilities, personality, behavioral coping styles, and pain levels in predicting changes from trait to state preferences and preferred music characteristics under various pain conditions.

Cancer patients were recruited to fill in questionnaires pertaining to their demographic information (age, gender, religious preference, ethnicity, music background and experience), personality traits, music preferences, preferences for music characteristics, coping styles, and pain experiences.


Eligibility criteria: Inclusion Criteria:

1. Stage IV cancer diagnosis
2. Between 40 - 70 years old
3. Normal or corrected hearing
4. Able to communicate (speak, comprehend, read, write) in English
5. Signed informed consent form

Exclusion Criteria:

1. Under 40 or over 70 years old
2. Not able to communicate in English
3. Uncorrected hearing loss/impairment
4. Dementia, psychosis (hallucinations, delusions) that interferes with cognitive processing (verbal and music)

Primary outcomes:
measure: Pain on the McGill Pain Questionnaire
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Kate Gfeller, PhD, MT-BC
role: STUDY_CHAIR
References:
Clinical trial NCT01300039: Oral Antibiotic Treatment of Helicobacter Pylori Reduces Intestinal Colonization Rates With Oxalobacter Formigenes
Official title: Oral Antibiotic Treatment of Helicobacter Pylori Reduces Intestinal Colonization Rates With Oxalobacter Formigenes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrolithiasis
Keywords: nephrolithiasis
urolithiasis
hyperoxaluria
Helicobacter pylori
Lead sponsor: VA New York Harbor Healthcare System
Sponsor class: FED
First posted: 2011-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing upper endoscopy for any indication and who would have determination of presence or absence of H. pylori. Stool samples then positive for colonization with Oxalobacter formigenes.

Brief summary: The investigators are finding out if giving antibiotics for Helicobacter pylori will eliminate colonization of the colon by Oxalobacter formigenes.

Detailed description: Background and objectives: Oxalobacter formigenes (OF) may play a protective role in preventing calcium oxalate stones. Intestinal colonization by OF is associated with reduced urinary oxalate excretion. Exposure to antibiotics may be an important factor contributing to variable rates of colonization. This is the first prospective study to evaluate the effect of antibiotics on OF colonization.

Design, setting, participants, \& measurements: The effect of antibiotics on OF colonization was compared in 2 groups: a group receiving antibiotics for gastric infection with Helicobacter pylori (HP) and a group without HP that not receiving antibiotics. OF colonization in stool was detected by oxalate degradation at baseline and after 1 and 6 months.

Eligibility criteria: Inclusion Criteria:

* age 18-80 years old
* undergoing upper endoscopy
* H. pylori present or absent on gastric histology
* stool positive for Oxalobacter formigenes

Exclusion Criteria:

* unable to consent
* stool negative for Oxalobacter formigenes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: New York Harbor VA Medical Center
name: David S Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04612439: Accuracy of VABB Elite 10G Versus BARD 14G CNB
Official title: Accuracy of Vacuum-assisted Breast Biopsy Elite 10G Versus BARD 14G Core Needle Biopsy of Abnormal Breast Lesions.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 1470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this study, patients whose breast ultrasound showed a space-occupying lesion and needed biopsy to clarify the pathology were selected as the research subjects. This study aims to determine whether Vacuum-assisted biopsy device Elite is superior to the traditional BARD ejection type air core needle in the diagnosis of breast cancer through a prospective randomized study.

Detailed description: The main purpose of the study was to analyze the difference in the accuracy of two biopsy devices in the diagnosis of breast cancer puncture. The purpose of the secondary study was to analyze the difference between the underestimation rate, false negative rate, sensitivity, and negative predictive value of the two devices, the consistency of the immunohistochemistry between the puncture pathology and surgical pathology of the two groups of patients, the number and time-consuming of the puncture acquisition specimens, and the two biopsies Differences in the incidence of complications (safety).

If the biopsy device is a vacuum-assisted Elite 10G needle, insert the needle groove into the mass and rotate to cut the biopsy tissue one circle; If the biopsy device is a BARD 14G hollow core needle, insert the needle to the edge of the mass and pull the trigger in different directions to eject the needle to retrieve the material.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old (including 18 years old)
* Ultrasound examination indicates the presence of space-occupying lesions in the breast. The size, location, and BI-RADS classification are not limited.
* Agree to undergo surgery after puncture
* Ability and willingness to sign informed consent

Exclusion Criteria:

* A biopsy has been performed in the external hospital
* Contraindications for puncture or surgery such as severe coagulation dysfunction
* Refuse breast surgery
* Axillary lymph node puncture

Primary outcomes:
measure: Accuracy
timeFrame: 3 months
Secondary outcomes:
measure: Concordance of immunohistochemical marker status
timeFrame: 3 months
measure: Sensitivity
timeFrame: 3 months
measure: Negative Prediction Value
timeFrame: 3 months
measure: Underestimation Rate
timeFrame: 3 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 7 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Junjie Li, MD
role: STUDY_DIRECTOR
affiliation: Fudan University
name: Ying Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04820439: Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection
Official title: Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection (HS627) and Perjeta ® in Healthy Male Subjects: a Randomized, Double-blind, Parallelity-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male aged 18-40.
* The body mass index is in the range of 19-26 kg/m2 (including thecritical value). The weight is 50 kg-80kg.
* The subjects have no family planning within 3 months and could select contraceptive method
* The subjects who have signed the informed consent and are able to complete the experiment according to the trial protocol.
* Echocardiography showed left ventricular ejection fraction (LVEF) \> 50% ,which two weeks before administration of experimental drug.

Exclusion Criteria:

* The subjects with a history of malignant tumor.
* The subjects who has received any live vaccine within 6 months prior to signing the informed consent.
* The subjects who has upper respiratory tract infection or other acute infections within the previous 2 weeks of screening.
* The subjects who had undergone surgery within 2 months prior to signing the informed consent.
* Anti-drug antibody (ADA) detection positive.
* Previous treatment with any antibody targeting the HER2 receptor or Those who have used monoclonal antibodies within 6 months prior to signing the informed consent.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)0-∞
timeFrame: 150 days
measure: Area under the plasma concentration versus time curve (AUC)0-t
timeFrame: 150 days
measure: Peak Plasma Concentration (Cmax)
timeFrame: 150 days
Secondary outcomes:
measure: The total clearance(CL)
timeFrame: 150 days
measure: elimination half-life time(T1/2)
timeFrame: 150 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase I Clinical Research Center
state: Shandong
Study officials:
References: