louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03387644: Pregabalin Premedication for Conscious Sedation
Official title: Pregabalin Premedication for Conscious Sedation for Flexible Bronchoscopy: A Randomized Double Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conscious Sedation
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Conscious sedation is usually required during flexible bronchoscopy. Sedation should be done without causing respiratory depression or loss of consciousness. The present study was designed to evaluate the advantage of pregabalin pre-medication on reducing sedatives and respiratory depression for patients undergoing flexible bronchoscopy with dexmedetomidine and midazolam.

Detailed description: Seventy patients undergoing elective flexible bronchoscopy were randomly divided into two equal groups, 35 patients each. All patients received premedication one hour before the procedure. PG group received 150 mg pregabalin and C group received placebo. All patients sedated to achieve optimum working conditions. Intra-operative respiratory rate and post procedure patients' and pulmonologists' satisfaction were compared in both groups.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 21 and 65 years old American Society of Anaesthesiologists physical status II or III scheduled for elective flexible bronchoscopy

Exclusion Criteria:

* Patients with known allergy to any drug used in the study, chronic use of analgesics and/or sedatives, substance abuse, sleep apnea, renal or hepatic dysfunction, and psychiatric disorders.

Primary outcomes:
measure: Total amount of sedative
timeFrame: 45 minutes during the procedure
Secondary outcomes:
measure: Patients' satisfaction
timeFrame: 30 minutes after the end of the procedure.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01143740: A Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
Official title: An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/=18 years of age
* well differentiated and/or dedifferentiated liposarcoma eligible for tumor debulking surgery
* willing to undergo tumor biopsies before, during and after treatment
* ECOG performance status 0-1

Exclusion Criteria:

* previous chemotherapy and/or radiation for liposarcoma; previous debulking surgery is acceptable
* patients receiving any other agent or therapy to treat their malignancy
* patients requiring anticoagulant therapy and/or anti-platelet therapy
* pre-existing gastrointestinal disorders which may interfere with absorption of drugs
* history of seizure disorders or unstable CNS metastases
* clinically significant cardiovascular disease
* history of long QT syndrome

Primary outcomes:
measure: Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)
timeFrame: from baseline to week 12
Secondary outcomes:
measure: Safety and tolerability: Adverse events, laboratory parameters, ECG
timeFrame: up to approximately 4 months after study start
measure: Tumor response according to RECIST criteria assessed by CT or MRI
timeFrame: from baseline to week 7
measure: Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers
timeFrame: multiple sampling weeks 1 and 2
Other outcomes:
Locations:
city: Bordeaux
country: France
city: Lille
country: France
city: Lyon
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05505240: Influence of Ambient Temperature on Resting Energy Expenditure of Healthy Adults
Official title: Influence of Ambient Temperature on Resting Energy Expenditure of Metabolically Healthy Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resting Energy Expenditure
Keywords: Resting energy expenditure
Resting metabolic rate
Ambient temperature
Environmental temperature
Lead sponsor: University of Bonn
Sponsor class: OTHER
Collaborators: name: DLR German Aerospace Center
First posted: 2022-08-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the influence of four different ambient temperatures (18, 22, 28, 38°C) on the resting energy expenditure of healthy adults by respiratory gas analysis. It is assumed that the resting energy expenditure is higher at 18°C and 38°C than at the temperatures in between.

Detailed description: In a crossover-design, 32 healthy men and women participate in four interventions. Each intervention includes a measurement of the resting energy expenditure by respiratory gas analysis at a different ambient temperature (18,22, 28 and 38°C). During this time body core- and surface temperature are assessed, as well as body composition via bioelectrical impedance analysis. For each participant the four individual study days take place in a randomized order on consecutive weekdays within a week.

Eligibility criteria: Inclusion Criteria

* BMI: 18,5 - 24,9 kg/m2
* metabolically healthy

Exclusion Criteria

* smoking
* low or high blood pressure
* dyslipidemia
* insulin resistance or diabetes mellitus type 1 or type 2
* gastrointestinal diseases (e.g. food intolerances or allergies)
* liver, kidney and/or thyroid diseases
* hepatitis B or C, HIV Infection
* chronic inflammatory diseases
* disordered eating
* psychological diseases
* alcohol and/or drug abuse
* use of medication
* pregnancy or lactating
* participation in another intervention study
* women: irregular menstrual cycle
* more than 6 h of sports per week

Primary outcomes:
measure: Resting Energy Expenditure
timeFrame: 20 minutes
Secondary outcomes:
measure: Body core temperature
timeFrame: 20 minutes
measure: Body surface temperature
timeFrame: 20 minutes
measure: Body composition
timeFrame: 5 minutes (after respiratory analysis)
measure: Blood pressure
timeFrame: 10 minutes (at beginning of study day)
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
Study officials:
affiliation: University of Bonn
name: Sarah Egert, Prof. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00874640: Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)
Official title: Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidemiologic Factors
Keywords: Drug utilization review
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-04-02
Enrollment: 3711
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Radiological practice

Brief summary: To evaluate patient characteristics in the current daily radiological practice of Gadovist application. Special focus will be laid on the individual risk factors of patients, the indications for and the dose of Gadovist application.

Secondary objective is to prove the known safety profile (especially rare adverse events) of Gadovist and to collect data on handling problems with different application forms (one questionnaire per center).


Eligibility criteria: Inclusion Criteria:

* patients with indication for a MRT or MR-Angiography and for whom the radiologist has decided to use the contrast medium Gadovist

Exclusion Criteria:

* No exclusion criteria besides the contraindications for the use of Gadovist as mentioned in the German product information.

Primary outcomes:
measure: Patient Profile
timeFrame: At day of application
Secondary outcomes:
measure: Dosing of Gadovist in different indications
timeFrame: At time of application
measure: Adverse Events
timeFrame: Throughout and after application
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05799040: Evaluation of the Effectiveness of the Self-developed Pulmonary Lobar Ventilation Detector
Official title: Evaluation of the Effectiveness of the Self-developed Pulmonary Lobar Ventilation Detector
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic obstructive pulmonary disease

Brief summary: The goal of observational study is to Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector.

Participants will use the self-developed pulmonary lobar ventilation detector and the imported Chartis detection system to evaluate the target pulmonary lobar collateral ventilation.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic obstructive pulmonary disease who meet the GOLD diagnostic criteria
* FEV1 ≤ 45% pred and FEV1/FVC\<70%
* TLC\>100% pred and RV\>175% pred
* CAT≥18
* \>50% of emphysema destruction
* Smoking prohibition\>6 months
* Sign the informed consent form

Exclusion Criteria:

* PaCO2\>8.0 kPa, or PaO2\<6.0 kPa
* 6-minute walking test\<160m
* Obvious chronic bronchitis, bronchiectasis or other infectious lung diseases
* Three hospitalizations due to pulmonary infection in the past 12 months before the baseline assessment
* Previous lobectomy, LVRS or lung transplantation
* LVEF\<45% and or RVSP\>50mmHg
* Anticoagulant therapy that cannot be stopped before surgery
* The patient has obvious immune deficiency
* Participated in other lung drug studies within 30 days before this study
* Pulmonary nodules requiring intervention
* Any disease or condition that interferes with the completion of the initial or subsequent assessment

Primary outcomes:
measure: Therapeutic effect of lung volume reduction surgery
timeFrame: 1 month after bronchoscopic valve lung volume reduction
measure: Therapeutic effect of lung volume reduction surgery
timeFrame: 3 months after bronchoscopic valve lung volume reduction
measure: Therapeutic effect of lung volume reduction surgery
timeFrame: 6 months after bronchoscopic valve lung volume reduction
measure: the integrity of interlobar fissure
timeFrame: Before bronchoscopic valve lung volume reduction
Secondary outcomes:
Other outcomes:
Locations:
city: BeiJing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02459340: Emotional and Cognitive Self-regulation, an EEG Study
Official title: Effectiveness of Therapeutic Treatment: Hot and Cold Self-regulation in Posttraumatic Stress Disorder and Dissociative Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Posttraumatic Stress Disorder (cPTSD)
Dissociative Disorder Not Otherwise Specified (DDNOS)
Dissociative Identity Disorder (DID)
Lead sponsor: Clienia Littenheid AG
Sponsor class: OTHER
Collaborators: name: Clienia Littenheid AG
name: University of Zurich
First posted: 2015-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main goal of the proposed project is to assess treatment-induced changes of electrophysiological and psychophysiological correlates of the capacity to regulate emotion, executive functions, and clinical measures in individuals with complex posttraumatic stress disorder and dissociative disorders in a naturalistic inpatient setting.


Eligibility criteria: Inclusion Criteria:

-ability to undergo EEG measurement/psychophysiological measurement

Exclusion Criteria:

* regular substance use
* acute suicidality
* comorbid psychosis

Primary outcomes:
measure: event-related potential (ERP)
timeFrame: up to 6 months
measure: power in specific frequency bands
timeFrame: up to 6 month
Secondary outcomes:
measure: heart rate
timeFrame: up to 6 months
measure: electrodermal activity
timeFrame: up to 6 months
measure: executive function
timeFrame: up to 6 months
measure: measurement of psychological symptoms
timeFrame: up to 6 month
measure: assessment of emotion regulation and dysregulation
timeFrame: up to 6 month
Other outcomes:
Locations:
city: Littenheid
country: Switzerland
facility: Privat Clinic Clienia Littenheid
state: Thurgau
Study officials:
affiliation: Privat Clinic Clienia Littenheid
name: Silke Bachmann, Prof. Dr. med.
role: STUDY_DIRECTOR
affiliation: Privat Clinic Clienia Littenheid, University of Zurich
name: Yolanda Schlumpf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schlumpf YR, Nijenhuis ERS, Klein C, Jancke L, Bachmann S. Functional connectivity changes in the delta frequency band following trauma treatment in complex trauma and dissociative disorder patients. Front Psychiatry. 2022 Jul 25;13:889560. doi: 10.3389/fpsyt.2022.889560. eCollection 2022.
citation: Schlumpf YR, Nijenhuis ERS, Klein C, Jancke L, Bachmann S. Resting-state functional connectivity in patients with a complex PTSD or complex dissociative disorder before and after inpatient trauma treatment. Brain Behav. 2021 Jul;11(7):e02200. doi: 10.1002/brb3.2200. Epub 2021 Jun 9.
Clinical trial NCT05190640: Study to Evaluate the Efficacy of Asystems' Complete Calm Supplementation on Sleep Quality and Duration, Anxiety, and Stress
Official title: Study to Evaluate the Efficacy of Asystems' Complete Calm Supplementation on Sleep Quality and Duration, Anxiety, and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Stress
Anxiety
Lead sponsor: Asystem, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-01-13
Enrollment: 35
Sex: ALL
Minimum age (years): 24
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an open-label observational single-arm clinical trial to study the efficacy of a commercial dietary supplement and its effect on sleep quality, sleep duration, anxiety, mood, and stress.

Detailed description: It is hypothesized that the dietary supplement marketed as "Asystems Complete Calm" (consisting of De-Stress Gummies and Sleep Gummies) will improve subjective wellbeing in trial participants, through promoting restful sleep (looking at sleep quality and duration), and reducing stress and anxiety, while lifting up the participants' mood.

A total of 35 participants will be recruited for the trial following the screening. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants, and all participants will take the Complete Calm Product, consisting of the De-Stress Gummies (day) and Sleep Gummies (night) for four weeks.

Eligibility criteria: Inclusion Criteria:

* Male \& Female between 24-45 years old
* Self-reported (undiagnosed) mild to moderate sleep issues
* Self-reported (undiagnosed) mild to moderate anxiety
* Self-reported stressful lifestyle
* Must be in good health (don't report any medical conditions asked in the screening questionnaire)
* Following a stable, consistent diet regimen
* Willing to maintain current dietary pattern, activity level, and stable body weight for the duration of the study, and refrain from any drastic lifestyle changes

Exclusion Criteria:

* Currently taking any prescription anti-depressants
* Currently receiving other psychotherapeutic treatment for anxiety or depression
* Severe chronic conditions including oncological conditions, psychiatric disease, or other
* Diagnosed insomnia
* Diagnosed anxiety or depression
* Food intolerances/allergies that require an epipen
* Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding

Primary outcomes:
measure: Change in sleep quality [Time Frame: Baseline to 4 weeks)
timeFrame: 4 weeks
measure: Change in stress and anxiety [Time Frame: Baseline to 4 weeks)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Susanne Mitschke, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05138640: Bone Strength and Physical Activity in Patients With a Recent Clinical Fracture
Official title: Prospective Evaluation of Bone Strength, Physical Activity, Falls, Subsequent Fractures and Mortality in Patients Presenting With a Recent Clinical Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures, Bone
Patient Fall
Osteoporosis
Physical Activity
Lead sponsor: VieCuri Medical Centre
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
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 recent fracture evaluated at the FLS at VieCuri MC Venlo

Brief summary: The risk for a subsequent fracture is significantly higher in patients presenting with a fracture compared to individuals without a previous fracture and is highest within the first 2 years after the initial fracture. The risk for a subsequent fracture is not dependent of BMD as measured by conventional DXA. In recent studies, it has been shown that HRpQCT measurements provide information about bone structure, bone quality and bone strength in addition to BMD measurements. Diagnostic strategies should be focussed on bone quality and bone strength and fall prediction in the patients at high risk for falls, subsequent fracture and mortality such as patients with a recent fracture. Therefore, the investigators conduct a prospective observational study in 500 patients aged 50 years and older who present with a clinical fracture for evaluation of bone strength, physical activity, falls, subsequent fractures and mortality during a follow-up period of 3 years.


Eligibility criteria: Inclusion Criteria:

* Patients aged 50 years and older with a recent fracture that is being evaluated at the FLS at VieCuri MC.
* Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical study procedures
* Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.

Exclusion Criteria:

* Patients with malignancy metastatic to the bone.
* Patients with osteomyelitis.
* Patients with fractures due to failure of a prosthesis.
* Patients, who as judged by the Principal Investigator, are mentally incompetent. Patients who are compos mentis and understand the patient information, will not be considered mentally incompetent

Primary outcomes:
measure: Bone strength assessed with HRpQCT
timeFrame: 3 years
Secondary outcomes:
measure: Subsequent falls within 3 years after a fracture
timeFrame: 3 years
measure: Mortality
timeFrame: 3 years
Other outcomes:
Locations:
city: Venlo
country: Netherlands
facility: VieCuri Medical Centre
state: Limburg
Study officials:
affiliation: VieCuri Medical Centre
name: J PW van den Bergh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02252744: Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis
Official title: Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Rheumatoid Arthritis
Keywords: dry eye disease
rheumatoid arthritis
Lead sponsor: Western University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2014-09-30
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of rheumatoid arthritis

Brief summary: This study will evaluate the prevalence of dry eye disease in patients diagnosed with rheumatoid arthritis. No treatment is administered in this study.

Detailed description: We investigated the prevalence of dry eye disease in patients diagnosed with rheumatoid arthritis by information sheets and direct recruitment of patients of potential study participants diagnosed with rheumatoid arthritis. Subjective assessment for dry eye disease was performed using Ocular Surface Disease Index (OSDI) questionnaire. The following objective tests of dry eye disease were employed: tear osmolarity (TO), tear break-up time (TBUT), corneal fluorescein staining score and conjunctival lissamine green staining scores using the National Eye Institute-recommended grading system, and Schirmer without anesthetic. The Dry Eye Severity Grading Scheme highlighted by the Dry Eye WorkShop was adapted to quantify dry eye disease severity level.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with rheumatoid arthritis
* 18 years old or older
* Speaks and understands English and/or Spanish

Exclusion Criteria:

* Unable to provide consent

Primary outcomes:
measure: Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Western University of Health Sciences
name: Jasmine W Yumori, OD FAAO
role: PRINCIPAL_INVESTIGATOR
References: