louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02096640: Postoperative Inflammation and Recovery After Tracheostomy
Official title: Randomized Controlled Trial on the Effect of Percutaneous Dilatation Tracheostomy Compared to Open Surgical Tracheostomy on Postoperative Inflammation, Pulmonary Function, Peri- and Postoperative Complications and Physical Mobilization.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheostomy Complication
Inflammation
Post-operative Complications
Lead sponsor: Sormland County Council, Sweden
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to examine if there are differences in postoperative inflammation following percutaneous dilatation tracheostomy versus surgical tracheostomy in intensive care unit patients.

Detailed description: Are there differences between the two arms in plasma concentrations of inflammatory mediators (TNF-alfa, interleukin 1, 6, 10) at 24 hrs following the start of the surgical procedure? Are there differences between the two arms in the incidence of postoperative complications (i.e. bleeding, incidence of stomal infections, tracheal tube dislocation, airway compromisation), postoperative pulmonary infection (during the stay in the ICU) and pulmonary function (FEV1, dynamic complicance, oxygen demand, time to weaning off the ventilator: all measured daily during the ICU-stay), postoperative mobilization (time to mobilization to sitting, standing and walking, respectively)?

Eligibility criteria: Inclusion Criteria: Patients in whom a tracheostomy is indicated (i.e. anticipated need of mechanical ventilation for \>7 days or anticipated risk for complicated extubation, e.g. anatomical signs of a compromised airway, reduced level of consciousness. Adults over 18 years. Participants who are suitable for both surgery techniques.

Exclusion Criteria:

Children under 18 years, pregnancy and participants with anatomical defects that exclude them from percutaneous dilatation tracheostomy.

Primary outcomes:
measure: Change in inflammation markers in plasma
timeFrame: Preoperative and 24 hours after the start of surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: Until discharge from the ICU
Other outcomes:
measure: Physical function
timeFrame: One week after tracheostomy
Locations:
city: Eskilstuna
country: Sweden
facility: Intensivvårdsavdelningen på Mälarsjukhuset
state: Sörmland
Study officials:
affiliation: Centre for Clinical Research, Uppsala University
name: Markus Castegren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04711044: Investigation of a New Human Model for Itch
Official title: Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itch
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This third sub-project aims to evaluate the interaction between the TRPM8 receptor and pruritus by studying the anti-pruritic effect of TPRM8-agonist L-menthol on histaminergic and non-histaminergic itch induced using three different pruritogens: histamine, cowhage and papain.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other addictive drugs
* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.).
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers, as well as systemic or topical steroids.
* Skin diseases
* Moles, scars or tattoos in the area to be treated or tested.
* Hypersensitivity to papaya and mango fruit, cashew nuts, rubber latex
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Primary outcomes:
measure: Measuring itch intensity by computerized Visual Analog Scale Scoring
timeFrame: For 15 minutes
measure: Measuring pain intensity by computerized Visual Analog Scale Scoring
timeFrame: For 15 minutes
measure: Superficial blood perfusion measurement
timeFrame: After 15 minutes
measure: Measuring Alloknesis
timeFrame: 15 minutes
Secondary outcomes:
measure: Measurement of Cold Detection Thresholds (CDT)
timeFrame: 15 minutes
measure: Measurement of Cold PainThresholds (CPT)
timeFrame: 15 minutes
measure: Measurement of Heat Pain Thresholds (HPT)
timeFrame: 15 minutes
measure: Measurement of Warm Detection Thresholds (WDT)
timeFrame: 15 minutes
measure: Measurement of Pain to Supra-threshold Heat Stimuli
timeFrame: 15 minutes
measure: Measurement of Mechanical Pain Thresholds (MPT)
timeFrame: 15 minutes
measure: Measurement of Mechanical Pain Sensitivity (MPS)
timeFrame: 15 minutes
measure: Touch Pleasantness (TP)
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Nordjylland
Study officials:
References:
Clinical trial NCT00092144: Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral MK0476 Vs Placebo During the Allergy Season in Patients With Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy Season
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.


Eligibility criteria: Inclusion Criteria:

* Asthma symptoms brought on by allergies

Exclusion Criteria:

* Patient has any lung disease
* Currently have a sinus infection or cold symptoms

Primary outcomes:
measure: To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period
Secondary outcomes:
measure: To assess the following over a 3-week treatment period:
measure: nighttime symptoms
measure: AM PEFR
measure: PM PEFR
measure: B-agonist use
measure: asthma attacks
measure: discontinuations due to asthma
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Busse WW, Casale TB, Dykewicz MS, Meltzer EO, Bird SR, Hustad CM, Grant E, Zeldin RK, Edelman JM. Efficacy of montelukast during the allergy season in patients with chronic asthma and seasonal aeroallergen sensitivity. Ann Allergy Asthma Immunol. 2006 Jan;96(1):60-8. doi: 10.1016/S1081-1206(10)61041-1.
Clinical trial NCT04337840: Analysis on the Infection Risk, Prognosis, and Drug Sensitivity of Klebsiella Pneumoniae.
Official title: Analysis on the Infection Risk, Prognosis, and Drug Sensitivity of Klebsiella Pneumoniae.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Klebsiella Pneumoniae Sepsis
Keywords: risk factors ,outcomes,Drug Susceptibility,Klebsiella pneumoniae
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was conducted at the National Taiwan University Hospital (NTUH), a medical center with 2400 beds in Taipei City. We studied patients with K. pneumoniae bloodstream infection between October 2017 and December 2019.

Brief summary: Nosocomial infections are increasing rapidly both internationally and domestically, especially carbapenem-resistant Klebsiella pneumoniae infections. However, there were still lack of evidence about the risk and prognosis in Taiwan. The choice of drug and related sensitivity test was also limited. We would analyze the infection risk, prognosis, and drug sensitivity of Klebsiella pneumoniae and focus on strategy to manage carbapenem-resistant Klebsiella pneumoniae infections.


Eligibility criteria: All adult patients (≥18 years) with K. pneumoniae bloodstream infection were included. Patients were excluded if there was other recognized bacteremia within two weeks before or after the first episode of K. pneumoniae bloodstream infection.

Primary outcomes:
measure: All-cause 28-day mortality
timeFrame: 2017-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chung Chuang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02627144: Bevacizumab in Metastatic Renal Cancer
Official title: AVASTIN® First Line in Metastatic Renal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Cancer
Keywords: Metastatic renal cell carcinoma
Avastin
Bevacizumab
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-12-10
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with advanced and/or metastatic renal cell cancer

Brief summary: This is a non-interventional, multicenter study to evaluate efficacy and safety of intravenous bevacizumab (Avastin) in combination with interferon alpha-2a immunotherapy for first-line treatment in participants with advanced and/or metastatic renal cell cancer (mRCC) in daily routine.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed advanced and/or metastatic renal cell cancer
* No contraindications for Avastin according to summary of product characteristics (SmPC)

Exclusion Criteria:

-

Primary outcomes:
measure: Percentage of Participants With Best Overall Tumor Response
timeFrame: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years
measure: Percentage of Participants With Disease Control
timeFrame: Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years
measure: Progression-free Survival (PFS) Time
timeFrame: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years
measure: Overall Survival (OS) Time
timeFrame: Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years
measure: Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Schultze-Seemann W, Schulz H, Tschechne B, Hackl M. Bevacizumab plus IFN-alpha-2a in First-line Treatment of Patients With Advanced or Metastatic Renal Cell Carcinoma: A Prospective German Non-interventional Study. Anticancer Res. 2019 Feb;39(2):875-882. doi: 10.21873/anticanres.13188.
Clinical trial NCT00905944: Exercise in Patients With a Biventricular Pacemaker
Official title: Effects of an Exercise Program on the Tendance to Severe Arrhythmias in Patients With Severely Impaired Left Ventricular Function and Cardial Re-synchronisation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Left Ventricular Failure
Keywords: Left ventricular failure
chronic heart failure
Pacemaker
Resynchronisation therapy
Exercise
Endurance exercise
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators will evaluate the effects of an exercise program (walking on a treadmill) on the physical performance, the cardiorespiratory function, the proclivity to heart arrhythmias and the quality of life of patients with severely impaired left ventricular function and a bi-ventricular resynchronization pacemaker.


Eligibility criteria: Inclusion Criteria:

* Left ventricular failure
* Resynchronization therapy with a biventricular pacemaker
* Ability to understand written German

Exclusion Criteria:

* Age over 75 years
* Severe cardiac arrhythmia
* All conditions which can be aggravated by an exercise program

Primary outcomes:
measure: Maximal oxygen uptake (VO2max)
timeFrame: At recruitment and after 12 weeks
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: At recruitment and after 12 weeks
measure: Brain natriuretic peptide (BNP)
timeFrame: At recruitment and after 12 weeks
measure: Body composition
timeFrame: At recruitment and after 12 weeks
measure: Mood
timeFrame: At recruitment and after 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
Study officials:
affiliation: Charite University, Berlin, Germany
name: Fernando Dimeo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05372744: Affect-regulatory Characteristics of Deceptive Placebos
Official title: The Influence of Expectations on Affect-regulatory Characteristics of Deceptive Placebos: An Experimental Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Depression
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study tries to identify whether specifically framed expectations, induced with an active placebo nasal-spray, have effects on affective regulation processes and rumination.

Detailed description: Healthy volunteers are informed that a new application method for an antidepressant, specialized on positively influencing the experience of aversive emotional states would be tested. They will randomly be assigned to a no treatment control group (not taking a placebo) or to one of the two treatment groups: Participants will be taking the antidepressant (which is in fact an active placebo) which will either protect them from experiencing intense emotional reactions and rumination (anticipatory group) or help them to regulate emotional states quicker as well as to distance themselves from ruminative thoughts (reactive group). Then, an aversive emotional state is induced by an autobiographical recall of events which made the participants feel inadequate, bashful, and ashamed. Currently experienced shame as well as state rumination are assessed before and after the negative recall task.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* fluent in German language

Exclusion Criteria:

* mental disorders
* allergic to capsaicin
* allergic to sesame oil
* intake of psychopharmacological drugs in the last four weeks
* intake of illegal drugs in the last two weeks
* consumption of alcohol in the last twelve hours
* students in medicine, pharmacy, or psychology
* completed studies in medicine, pharmacy or psychology
* current pregnancy or lactation
* cardio vascular disease
* kidney disease
* liver disease

Primary outcomes:
measure: Change in Experienced Shame (Experienced Shame Scale, 'ESS')
timeFrame: At baseline and after autobiographical recall. Each assessment is taking 5 minutes, in total 10 minutes.
Secondary outcomes:
measure: Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung)
timeFrame: At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes.
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps-Universität Marburg
Study officials:
References:
Clinical trial NCT02592044: Effect of Aromatherapy on Venopuncture Pain and Anxiety
Official title: Evaluation of the Effect of Aromatherapy With Lavender Essential Oil on Pain and Anxiety During Peripheral Venous Cannulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pain
anxiety
Catheterization, Peripheral
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of aromatherapy with lavender essential oil on pain and anxiety during venipuncture will be evaluated.

Detailed description: The anxiety and pain during venipuncture may be cause to the avoidance of the medical therapy in patient as well as adult. Aromatherapy with lavender was shown that beneficial effects on chronic pain and anxiety. It's effect on acute pain and anxiety is not exactly known. In this study, the aromatherapy with the lavender will be compared with placebo to evaluate the analgesic and anxiolytic effect during peripheral venous cannulation before surgery.

Eligibility criteria: Inclusion Criteria:

* be scheduled for elective surgery
* be accepted to inhale lavender

Exclusion Criteria:

* age \<18 years \>65 years
* preoperative pain or consumption of analgesic medication
* anxiety disorders or consumption of anxiolytic medications (i.e. SSRI, benzodiazepine)
* pregnancy or breastfeeding
* asthma, chronic obstructive pulmonary disease
* poor sense of smell
* allergy to the lavender essential oil

Primary outcomes:
measure: Pain Level
timeFrame: Within the first 5 minutes after the peripheral venous cannula insertion process
Secondary outcomes:
measure: Anxiety Level
timeFrame: Within the first 5 minutes after the peripheral venous cannula insertion process
measure: Patient Satisfaction
timeFrame: Within the first 15 minutes after the peripheral venous cannula insertion process
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University Medical School
Study officials:
affiliation: Gaziosmanpasa University
name: Tugba Karaman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01181544: A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis
Official title: Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure Chronic Requiring Hemodialysis
Keywords: Anticoagulation
Heparin
Hemodialysis
Dialysis
Renal Dialysis
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Louisville
name: Gambro Renal Products, Inc.
name: Baxter Healthcare Corporation
First posted: 2010-08-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: During hemodialysis treatments, patients receive heparin to prevent clotting. The purpose of this pilot study is to determine if the amount of heparin administered during a patient's hemodialysis can be individualized using an equation for heparin dose adjustment.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age or older
* Stable hemodialysis prescription prior to study enrollment
* Dialyzing through a native fistula or Gore-Tex graft
* Blood access must be able to provide a blood flow rate of 400 ml/min

Exclusion Criteria:

* Non-compliance with dialysis
* Hematocrit less than 28%
* Active Infection
* Diagnosis of Heparin-Induced Thrombocytopenia (HIT)

Primary outcomes:
measure: Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Evaluation of dialyzer performance and visual assessment of clotting in the fiber bundle and the arterial and venous headers
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Richard A. Ward, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farrell PC, Ward RA, Schindhelm K, Gotch F. Precise anticoagulation for routine hemodialysis. J Lab Clin Med. 1978 Aug;92(2):164-76.
citation: Smith BP, Ward RA, Brier ME. Prediction of anticoagulation during hemodialysis by population kinetics and an artificial neural network. Artif Organs. 1998 Sep;22(9):731-9. doi: 10.1046/j.1525-1594.1998.06101.x.
citation: Robbins H, Monro S. A stochastic approximation method. Ann Math Stat 22:400-407, 1951.
citation: Association for the Advancement of Medical Instrumentation: Reuse of Hemodialyzers (ANSI/AAMI RD47:2003). Association for the Advancement of Medical Instrumentation, Arlington, VA, 2003.