louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04888845: Refinement of Suicide Risk Management Intervention
Official title: Refinement of Suicide Risk Management Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Structured Interview
Narrative Assessment
Safety Plan
Crisis Response Plan
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2021-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Participants will be randomly assigned to 1 of the 4 interventions using a sequential stratified randomization procedure. We will use sex (M, F) and history of suicide attempts (never, 1, and multiple) as our randomization strata. Participants will be assessed before and after the intervention to study the potential effects of each approach on suicide-related clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of suicide Ideation
* History of suicide attempts

Exclusion Criteria:

* Geographic location outside the U.S.

Primary outcomes:
measure: Change in suicide relevant thoughts and behaviors after the intervention (Self Injurious Thoughts and Behaviors questionnaire)
timeFrame: During an average of 2-weeks pre-intervention, 2-weeks post-intervention, 1 month follow-up after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Monika Lohani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238145: Postmarketing Surveillance Study of Atrovent® Inhaletten® in Chronic Obstructive Airways Disease
Official title: Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law] of Atrovent® Inhaletten® in Chronic Obstructive Airways Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 660
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive airways disease recruited at general practitioners, pneumologists, internists

Brief summary: To obtain further information on the tolerability and efficacy of Atrovent® inhaletten® in the treatment of chronic obstructive airways disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Primarily patients of both gender, older than 30 years,who suffer from chronic obstructive airways disease
* Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria:

- Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® Inhaletten®

Primary outcomes:
measure: Investigator assessment of improvement in the clinical picture of the course on a 6-point symptoms profile
timeFrame: Up to 4 weeks after first study drug administration
Secondary outcomes:
measure: Investigator assessment of tolerability on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
measure: Investigator assessment of efficacy on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
measure: Number of patients with adverse drug reactions
timeFrame: Up to 4 weeks after first study drug administration
measure: Number of patients who withdrew from the study
timeFrame: Up to 4 weeks after first study drug administration
measure: Number of patients who changed the concomitant medication
timeFrame: Up to 4 weeks after first study drug administration
measure: Number of patients who continued treatment
timeFrame: Up to 4 weeks after first study drug administration
measure: Patient assessment of tolerability on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
measure: Patient assessment of efficacy on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01727245: NEFA (Non Esterified Fatty Acid) , Adipose Factors Behind Insulin Sensitivity
Official title: The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Non-obese Controls
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Danderyd Hospital
name: Ersta Hospital, Sweden
name: Karolinska University Hospital
First posted: 2012-11-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).


Eligibility criteria: Inclusion Criteria obese:

* Bariatric surgery with laparoscopic gastric by-pass

Exclusion Criteria obese:

* diabetes mellitus typ 2 with insulin treatment and/or glitazones
* oral or parenteral steroid treatment
* complicated psychiatric disease
* Warfarin use

Inclusion Criteria non-obese controls:

* BMI under 30

Exclusion Criteria non-obese controls:

* diabetes
* oral or parenteral steroids treatment
* complicated psychiatric disease
* Warfarins use

Primary outcomes:
measure: Insulin sensitivity, adipose tissue function and gene function
timeFrame: two years after surgery
Secondary outcomes:
measure: Body composition
timeFrame: two years after surgery
measure: Vascular function
timeFrame: two years after surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Ersta Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Danderyds Hospital
Study officials:
affiliation: Karolinska Institutet
name: Erik Näslund, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mileti E, Kwok KHM, Andersson DP, Mathelier A, Raman A, Backdahl J, Jalkanen J, Massier L, Thorell A, Gao H, Arner P, Mejhert N, Daub CO, Ryden M. Human White Adipose Tissue Displays Selective Insulin Resistance in the Obese State. Diabetes. 2021 Jul;70(7):1486-1497. doi: 10.2337/db21-0001. Epub 2021 Apr 16.
citation: Backdahl J, Andersson DP, Eriksson-Hogling D, Caidahl K, Thorell A, Mileti E, Daub CO, Arner P, Ryden M. Long-Term Improvement in Aortic Pulse Wave Velocity After Weight Loss Can Be Predicted by White Adipose Tissue Factors. Am J Hypertens. 2018 Mar 10;31(4):450-457. doi: 10.1093/ajh/hpx201.
Clinical trial NCT00880945: Conventional Bronchoscopy Plus Rose Versus Electromagnetic Navigation (EMN) Plus Rose in Small Peripheral Lesions
Official title: Comparison of the Electromagnetic Navigation System and Rapid on Site Evaluation Versus Conventional Bronchoscopy and Rapid on Site Evaluation: Improved Yield in Small Peripheral Lung Lesions(Original Investigation)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Secondary Lung Cancer
Benign Lung Lesions
Keywords: FBS
coin lesions
ENB
ROSE
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2009-04-14
Enrollment: 40
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 with peripheral lesion suitable for surgery who need preoperative diagnosis will be studied, at first, with conventional bronchoscopy under fluoroscopic guidance. In case of non diagnostic procedure they will be candidates for ENB. All the patients will be candidates to surgical procedure in case of malignant lesions.

Brief summary: The aim of this study is to evaluate if Electromagnetic navigation (ENB) in combination with rapid on site evaluation (ROSE) can improve diagnostic accuracy in those patients who fail to be diagnosed with conventional fluoroscopic assisted bronchoscopy (FBS) in combination with ROSE.


Eligibility criteria: Inclusion Criteria:

* presence of small peripheral lung lesions (\< 3 cm) in patient suitable for surgical procedure

Exclusion Criteria:

* patient with metastatic disease
* patients unfit for surgical procedure

Primary outcomes:
measure: To evaluate the percentages of diagnosis that can be obtained adding ENB to conventional bronchoscopy in the same patient
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Novara
country: Italy
facility: azienda ospedaliera -universitaria Maggiore della carità
Study officials:
affiliation: UOA PNEUMOLOGIA NOVARA
name: piero em balbo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01581645: Mobilaser Study to Help With People Who Are Having Problems With Their Gait
Official title: Increasing Mobility in Parkinsonian Patients With Freezing of Gait and Gait Hypokinesia With an Adjustable, Attachable Laser (Mobilaser)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Parkinson's Disease
Parkinsonism
Keywords: Parkinson's disease
Parkinsonism
Gait problems
Freezing gait
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Does use of the Mobilaser reduce freezing of gait (FOG) and stride reduction in patients with Parkinson's disease and Parkinsonism.

Detailed description: Can patients walk faster and have less freezing when using the mobilaser then when not using it

Eligibility criteria: Inclusion Criteria:

* Parkinsonian patients with Freezing of Gait or Gait hesitation.
* Must have evidence of bradykinesia ambulating (stride reduction or reduced arm swing)
* Must have a constant caregiver

Exclusion Criteria:

* No cardiopulmonary contraindications to ambulation, e.g., unstable angina pectoris;
* Severe arthritis;
* Cerebellar or sensory ataxia;
* Recent knee or hip surgery

Primary outcomes:
measure: Improvement in Gait
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Jay Van Gerpen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00463645: Investigation of Correlation Between Interstitial and Arterial Blood Glucose Concentrations in Septic Patients
Official title: An Open, Mono-Centre Trial to Investigate the Correlation Between the Interstitial and Arterial Blood Concentrations of Glucose During Subcutaneous Glucose Monitoring in Patients With Severe Sepsis at the Medical Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This is a mono-centre trial performed at the medical ICU at the Medical University Graz. There will be a study visit (V1) and a follow-up assessment (V2). In the study visit (V1) arterial blood glucose values will be monitored and subcutaneous sampling of interstitial fluid (ISF) with microdialysis for glucose determination and with microperfusion for cytokine-measurement will be performed. The study visit will last for 26 hours starting with the insertion of two catheters in the abdominal subcutaneous tissue (one microdialysis- and one microperfusion catheter). The primary hypothesis of the study is: Interstitial fluid glucose concentration profiles correlates to the arterial blood glucose concentration profile in patients with severe sepsis in the medical ICU.


Eligibility criteria: Inclusion Criteria:

* Patients in the medical ICU fulfilling criteria for severe sepsis
* Mechanical ventilation
* Increased blood glucose levels ( \> 120 mg/dL; \> 6.7 mM), or requiring insulin treatment.
* Age of patients in the range from 18 to 90 years.

Exclusion Criteria:

* Any disease or condition which the Investigator or the treating physician feels would interfere with the trial or the safety of the patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Thomas R. Pieber, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02812745: Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia?
Official title: Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia? A Observational, Single-centre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Keywords: anaesthesia
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 45
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: patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth

Brief summary: Monitoring the bispectral index (BIS) as a peri-operative hemodynamic tool appears to be justified by the agreement between various clinical situations in which BIS monitoring appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death , and the diagnosis of amniotic fluid embolism. The current controversy concerning the "triple low" state reinforces the need for an accurate study in this field. Furthermore, the recent review by Bidd argues in this sense.


Eligibility criteria: Inclusion Criteria:

* Adult (over-18) patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth
* Good echogenicity
* Social security coverage

Exclusion Criteria:

* Pregnancy
* Subjects with black skin (a known technical limitation of plethysmography)
* Cardiac arrhythmia
* Sepsis
* Poor echogenicity
* Legal guardianship or incarceration
* Complications of anaesthesia during induction (anaphylactic shock, cardiac arrest, arrhythmia, or intubation not possible)

Primary outcomes:
measure: correlation between variations in the BIS and variations in cardiac output
timeFrame: Day 0
Secondary outcomes:
measure: correlation between cardiac output and the perfusion index (PI) during the induction of anaesthesia.
timeFrame: Day 0
measure: correlation between cardiac output and end-tidal carbon dioxide (etCO2) during the induction of anaesthesia.
timeFrame: Day 0
measure: correlation between the cardiac output and the value of brain tissue oxygenation (measured by near-infrared spectroscopy (NIRS)) during the induction of anaesthesia
timeFrame: Day 0
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Emmanuel LORNE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03509545: Comparison of Once Daily 40 mg Torsemide With Twice-daily 40 mg Furosemide
Official title: An Open Label,Crossover Study to Compare Once Daily Dose of 40 mg Torsemide Extended Release to Twice Daily of Furosemide on Natriuresis and Body Weight in Congestive Heart Failure (CHF) Patients Who Are on Stable Dose of Furosemide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Body Weight Changes
Keywords: natriuresis
Lead sponsor: Sarfez Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice daily Furosemide on 24-hour sodium excretion.

Detailed description: To compare the effects of 40 mg once-daily Torsemide ER to 40 mg twice-daily Furosemide on changes in body weight after two weeks of treatment. To compare the frequency and volume of urine passed in 24 hours. To compare the patients' quality of life and levels of natriuretic peptide between the two sets of patients.

Eligibility criteria: Inclusion Criteria:

* Patients of either gender over 18 years of age with clinical diagnosis of CHF and on a stable dose of 40 mg Furosemide.

Exclusion Criteria:

* Requirement for any other diuretic, history of cardiac dysrhythmia, other concurrent cardiovascular illness.

Primary outcomes:
measure: change in 24-hour sodium excretion compared to baseline
timeFrame: 24 hours
Secondary outcomes:
measure: Changes in body weight
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Syngene International
state: Karnataka
Study officials:
affiliation: Syngene
name: Anil K, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02695745: Experimental Biomarker Study for Pain Thresholds
Official title: Randomized, Double Blind, Positive- Controlled, Three-way Cross-over Human Experimental Biomarker Study of V116517 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2016-03-01
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by UVB (ultraviolet B) irradiation and topical capsaicin.


Eligibility criteria: Inclusion Criteria include:

1. Signed informed consent obtained.
2. Males aged 18 to 45, inclusive.
3. Body weight ranging from 50 to 100 kg and BMI ranging from 18 to 32 (kg/m2), inclusive.
4. Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.

Exclusion Criteria include:

1. Current or recent (within 5 years) history of drug or alcohol abuse.
2. History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
3. Any history of frequent nausea or emesis regardless of etiology.
4. Any history of allergic-type reactions to sulfonamides, or any experience of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDS.
5. Subjects who do not develop erythema at the maximum dose of the UVB source (MED determination for UVB model) will be excluded from the study.

Other protocol-specific inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application
timeFrame: 3.5 hours post-dose
Secondary outcomes:
measure: Heat Pain Threshold (HPTr)
timeFrame: 3.5 hours post-dose
measure: Heat Pain tolerance threshold (HPTolTr)
timeFrame: Pre-dose and 3.5 hours post-dose
measure: Pressure Pain Threshold (PPTr)
timeFrame: 3.5 hours post-dose
measure: Pressure Pain tolerance threshold (PPTolTr)
timeFrame: 3.5 hours post-dose
measure: Peripheral nociceptor activation using Laser Doppler flowmetry
timeFrame: 3.5 hours post-dose
measure: Erythema at the treated area using Erythema index
timeFrame: 3.5 hours post-dose
measure: Stimulus-response function to graded von Frey hair stimulation
timeFrame: 3.5 hours post-dose
measure: Secondary pin-prick hyperalgesic area
timeFrame: 3.5 hours post-dose
measure: Evaluation of change in body temperature
timeFrame: Pre-dose and up to 72 hours post-dose
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: CCBR A/S
Study officials:
References:
Clinical trial NCT01846845: Evaluation of a Novel Transfemoral Prosthetic Socket System
Official title: Prosthetic Socket System: Pilot Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Limb Amputation
Keywords: Amputee
Lead sponsor: Ohio Willow Wood
Sponsor class: INDUSTRY
Collaborators: name: Ohio State University
First posted: 2013-05-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.

Detailed description: Conventional transfemoral socket designs impose an array of limitations on transfemoral amputee patients. Flexion, extension, and abduction are considerably impaired and end basic functions like sitting are usually uncomfortable or even painful. An alternative socket design that lowers the socket trim-lines and still provides structural support would greatly improve the socket comfort for transfemoral amputees.

Eligibility criteria: Inclusion Criteria:

* Consenting Adult
* Unilateral transfemoral amputee
* Currently suing a liner with prosthesis
* Uses a prosthesis to ambulate
* Ability to read, write, and understand English
* Available during regular business hours for appointments

Exclusion Criteria:

* Impaired contra lateral leg
* Ambulates with the aid of an additional assistive device (e.g. walker, cane, etc.)
* Diagnosis of renal failure
* Smoker

Primary outcomes:
measure: Laser Doppler flowmetry tissue perfusion values
timeFrame: 1 month
Secondary outcomes:
measure: Laser speckle flowmetry tissue perfusion values
timeFrame: 1 month
measure: Hyperspectral Imaging Tissue Oxygen Saturation (StO2%)
timeFrame: 1 month
measure: Trans-Epidermal Water Loss values
timeFrame: 1 month
measure: Surface electrical capacitance values
timeFrame: 1 month
measure: Elasticity (cutometry) values
timeFrame: 1 month
measure: Torsional Ballistometry values
timeFrame: 1 month
Other outcomes:
measure: Skin temperature values
timeFrame: 1 month
measure: Prosthesis evaluation questionnaire (PEQ)
timeFrame: 1 month
Locations:
city: Columbus
country: United States
facility: The Ohio State University Davis Heart and Lung Research Institute
state: Ohio
city: Mt. Sterling
country: United States
facility: The Ohio Willow Wood Company
state: Ohio
Study officials:
affiliation: Ohio State University
name: Gayle Gordillo, MD
role: PRINCIPAL_INVESTIGATOR
References: