louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01604525: Tailored Web and Peer Email Cessation Counseling for College Smokers
Official title: RealU: Tailored Web and Peer Email Cessation Counseling for College Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-05-23
Enrollment: 1699
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The RealU2 is a randomized controlled trial to determine the efficacy of an online health and wellness program for young adults with the addition of individualized peer health coaching.

Detailed description: The RealU addresses smoking in a young adult population of occasional and daily smokers.

Aim 1. To determine the efficacy of providing individually tailored smoking cessation messages as part of a general interest website for young adults.

Aim 2. To determine the efficacy of providing individually tailored smoking cessation messages plus peer email, phone and online support as part of a general interest website for young adults.

Participants were recruited via direct emails sent to undergraduate and graduate students at the University of MI as well as direct emails sent to participants from Survey Sampling International and National Data Group. Individuals were invited to complete an online survey about health and hope in young adults. Participants eligible for the full intervention were invited to join the RealU Study.

Participants were asked to complete an online enrollment survey and consent form. Eligible, enrolled participants were randomly assigned to one of the following three study arms:

* an untailored general interest/lifestyle website
* an individually tailored web intervention about health and lifestyle
* an individually tailored web intervention about health and lifestyle with coaching from peers, including video, phone, and email

Assessments were conducted at 7 weeks and 12 weeks post-enrollment. The primary outcome measure is self-reported 30-day abstinence at 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Age 18-35
* Able to read English
* Internet access for the next 3 months
* Self-reported internet use of more than once per week
* Smoked at least one puff of a cigarette in the past 30 days

Exclusion Criteria:

* Use of smokeless tobacco in the past 30 days

Primary outcomes:
measure: Self-reported 30-day abstinence at Week 12
timeFrame: 12 weeks post-enrollment
Secondary outcomes:
measure: Self reported 7-day abstinence at 7 weeks
timeFrame: 7-weeks post-enrollment
measure: Self-reported 7-day abstinence at Week 12
timeFrame: 12-weeks post-enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01124825: Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study
Official title: Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Obesity
Keywords: Anesthesia induction and maintenance
Surgery
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2010-05-17
Enrollment: 0
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: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether two new airway devices used during anesthesia called iGEL™ and KING-LTS-DTM work well and are safe in obese patients. They both work well in thin patients, but have not been tested in obese patients.


Eligibility criteria: Inclusion Criteria:

* Scheduled for elective surgery with an estimated duration of 30 to 120 minutes
* American Society of Anesthesiologists (ASA) status I-III
* Aged 18 to 65 years.
* Body mass index (BMI) ≥ 35 kg/m2

Exclusion Criteria:

* A history of difficult intubation;
* Immobilized cervical spine;
* Oxygen saturation less than 95% at room air;
* A history of uncontrolled gastroesophageal reflux or hiatus hernia;
* A history of ulcer surgery including vagotomy;
* Previous gastric bypass surgery;
* Diabetic gastroparesis;
* Patients with known coagulation disorders (e.g. hemophilias, von Willebrand disease, factor V leiden diseases) or on systemic anticoagulation drugs (e.g. continuous heparin infusion); Patients with abnormal coagulation tests will be also excluded. However, asymptomatic patients will not be tested on any coagulation disorders.
* Any pathologies of the mouth, pharynx or larynx, the access to the airway is restricted, or a difficult tracheal intubation is anticipated.
* Pregnant or breast-feeding (pregnancy status will be confirmed by a pregnancy test, as it is standard for all surgical procedures at the University hospital).

Primary outcomes:
measure: Airway Sealing Pressure
timeFrame: 1-3 hours
Secondary outcomes:
measure: Difference in insertion time for one of the supraglottic airway devices
timeFrame: 1-3 hours
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Detlef Obal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.
Clinical trial NCT04689425: Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer
Official title: The Efficacy and Safety of Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcer
Umbilical cord blood mononuclear cells
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Umbilical cord blood mononuclear cells (MNC) may improve the wound repair ability. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.

Detailed description: The difficulty in the healing of diabetic foot is related to the loss of local repair microenvironment. The platelet rich plasma (PRP) can improve the repair ability, however, the requirement for wound bed preparation is strict, or treatment failure may occur. Umbilical cord blood mononuclear cells (MNC) may provide a better repair environment through paracrine action. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.

Eligibility criteria: Inclusion Criteria:

1. The age of the patients is 18-80 years old;
2. Diabetic foot is diagnosed and Wagner grade is above Ⅱ;
3. The duration of ulcer is 2 months or more, with no healing trend for 2 weeks or more.
4. Fasting blood glucose ≤ 9mmol / L, 2 hours postprandial blood glucose ≤ 13mmol / L;
5. The skin oxygen partial pressure around the wound is more than 20mmHg;
6. Sign written informed consent.

Exclusion Criteria:

1. Acute spreading infection of the wound, e.g. massive exudation, redness, swelling, heat, pain.
2. Acute myocardial infarction, heart failure, hepatitis;
3. Active bleeding or hematoma in the wound;
4. Serum albumin \<25g/L;
5. Hemoglobin \<80g/L;
6. Platelets \<50×109/L;
7. Poor cooperate or compliance;The patient cannot cooperate or is.
8. Mentally disabled.

Primary outcomes:
measure: Wound area reduction rate
timeFrame: one week
Secondary outcomes:
measure: Wound healing rate at 4 weeks
timeFrame: 4 weeks
measure: Amputation rate at 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital Wound Healing Center
name: Long Zhang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02873325: Registry on Salvage Antiviral Treatment for Patients Experiencing ADV and / or CMV Reactivation Post Allogeneic HSCT
Official title: European Patient Registry on Salvage Antiviral Treatment for Patients Experiencing Adenovirus and / or Cytomegalovirus Reactivation Post Allogeneic Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infectious Complications Following HSCT
Keywords: ADV
CMV
HSCT
Lead sponsor: Cell Medica Ltd
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this disease registry, data on approximately 120 allo HSCT patients who have received salvage treatment (second or later line) with any antiviral therapy for ADV and/or CMV post allogeneic HSCT will be documented; of these 120, at least 40 patients will have been treated with Cell Medica's immune reconstitution ACT as salvage therapy.

Brief summary: DESIGN:

Disease registry - non-interventional.

INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation.

Detailed description: In this disease registry, data on approximately 120 allo HSCT patients who have received salvage treatment (second or later line) with any antiviral therapy for ADV and / or CMV post allogeneic HSCT will be documented; of these 120, at least 40 patients will have been treated with Cell Medica's immune reconstitution ACT as salvage therapy. The patients will be consented prospectively or retrospectively for collection of data. Data will be collected at baseline, 6 months and 1 year after commencement of salvage treatment. Retrospective data collection (for patients who underwent HSCT in 2010 or later) is permitted.

Eligibility criteria: 1. Written informed consent
2. Physician requested salvage (defined as refractory to first, requirement for second line or greater) treatment for ADV and / or CMV reactivation post allogeneic HSCT.

Primary outcomes:
measure: ADV and/or CMV reactivations
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmigham Children Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital For Children
Study officials:
affiliation: Birmingham Children's Hospital
name: Prashant Hiwarkar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00655525: Omega-3 Fatty Acid Administration in Dialysis Patients
Official title: Omega-3 Fatty Acid Administration in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: inflammation
end stage renal disease
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-04-10
Enrollment: 38
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 overall goal of this study is to examine the role of fish oil supplementation in ameliorating the inflammatory state of uremia and the related muscle protein catabolism associated with this disease state. We hypothesize that if administered for a period of 3 months, fish oil will improve the chronic uremic inflammation. We further hypothesize that fish oil administration will improve the muscle protein breakdown associated with uremia and inflammation.


Eligibility criteria: Inclusion Criteria:

* Patients on CHD for more than 6 months;
* Ability to read and sign the consent form;
* Have acceptable dialysis adequacy (Kt/V \> 1.2);
* Use biocompatible hemodialysis membrane;
* Have a patent, well functioning, arteriovenous dialysis access or permanent dialysis catheter (no other option for arteriovenous access);
* Signs of chronic inflammation (average CRP of ≥ 5 mg/L for 3 consecutive measurements)

Exclusion Criteria:

* Pregnancy;
* Intolerance to the study medication;
* Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
* Diabetes mellitus on insulin therapy;
* Hospitalization within 1 month prior to the study;
* Malfunctioning arterial-venous vascular access (recirculation and/or blood flow \< 500 ml/min);
* Patients receiving steroids (\> 5 mg/day) and/or other immunosuppressive agents;
* Life-expectancy less than 6 months;
* Age less than 18 years old;
* Atrial fibrillation (only for those undergoing the optional Pulse Wave Velocity);
* Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery Doppler).

Primary outcomes:
measure: A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC)
timeFrame: 3 months
measure: A decrease in muscle protein breakdown
timeFrame: 3 months
Secondary outcomes:
measure: A decrease in concentration of acute phase reactants (serum C-reactive protein and plasma pro-inflammatory cytokines)
timeFrame: 3 months
measure: An increase in concentration of nutritional biomarkers (serum albumin and serum prealbumin)
timeFrame: 3 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alp Ikizler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01976130: Mechanisms of Lung Defense and Their Relationship With Airway Infection in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Mechanisms of Lung Defense and Their Relationship With Airway Infection in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bacterial Infection in COPD
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2013-11-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Study hypothesis:

Chronic Obstructive Pulmonary Disease (COPD) patients with chronic bacterial colonization have lower levels of mucins and antimicrobial peptides in their airways

Detailed description: Main objective:

(1) To investigate the expression of mucins and antimicrobial peptides in patients with severe COPD and their relationship with the presence of bacteria in the airway

Eligibility criteria: Inclusion Criteria:

* COPD

Exclusion Criteria:

* Acute exacerbation in the last 4 weeks

Primary outcomes:
measure: Mucins in sputum
timeFrame: Day 1
Secondary outcomes:
measure: Antimicrobial peptides in sputum
timeFrame: Day 1
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT02094430: Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency
Official title: Clinical Pharmacology, Efficacy and Safety Study of FGTW in Paediatric Patients With Severe Congenital Fibrinogen Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypofibrinogenemia, Congenital
Afibrinogenemia, Congenital
Lead sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Sponsor class: INDUSTRY
First posted: 2014-03-21
Enrollment: 16
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent form by parents or a legal representative
* Age less or equal to 12 years old
* Patients with inherited afibrinogenemia or severe inherited hypofibrinogenemia
* Negative results on HCG-based pregnancy test for females of childbearing potential (presence of menstruation)

Exclusion Criteria:

* Dysfibrinogenemia
* Acquired fibrinogen deficiency
* Suspected present or past anticoagulation inhibitor
* Personal history of venous or arterial thrombosis or thromboembolic event
* Co-morbidity with other/unrelated coagulopathies
* Administration of any fibrinogen concentrate or fibrinogen containing blood product during the last 15 days
* Permanent treatment with antithrombotic or anti-platelet agents such as heparins, anti-IIa or anti-Xa agents, aspirin, clopidogrel and NSAIDs.

Primary outcomes:
measure: Investigator's overall assessment of efficacy of FGTW on hemostasis using a 4-point scale at the end of each bleeding or surgical episode.
timeFrame: 6 hours or up to 5 days
measure: Terminal half life for Fibrinogen antigen and activity
timeFrame: 5 days
Secondary outcomes:
measure: Adverse Events
timeFrame: Participants will be followed for the duration of their participation in the study, an expected average of 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker enfants malades
city: Beirut
country: Lebanon
facility: Hôpital Hôtel Dieu
city: Rabat
country: Morocco
facility: Hôpital d'enfants - CHU Avicenne
city: Ankara
country: Turkey
facility: Faculty Ihsan Dogramaci Children's Hospital
Study officials:
References:
Clinical trial NCT01378130: Central Serous Chorioretinopathy: Etiology, Course and Prognosis
Official title: Central Serous Chorioretinopathy: An Observational Study About Etiology, Course and Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Serous Chorioretinopathy
Keywords: CCS
CSC
Subretinal Fluid
multimodal imaging
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 50
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 with an acute episode of central serous chorioretinopathy are recruited from the Department of Ophthalmology at the Medical University of Vienna.

Brief summary: Pathogenesis of central serous chorioretinopathy is not entirely understood yet, therefore further investigations are needed. During this study patients with an acute episode of central serous chorioretinopathy are observed with established ophthalmologic methods (multimodal imagine) every 6 weeks until subretinal fluid is reabsorbed to gain further insides in etiology, course and prognosis of this disease.

Detailed description: Patients with central serous chorioretinopathy are recruited from the Department of Ophthalmology at the Medical University of Vienna. All patients undergo ETDRS visual acuity measurement, Pelli-Robson contrast examination, Amsler-Grid testing, questionnaire testing, ophthalmologic examination, SD-OCT and polarization-sensitive OCT, fundus autofluorescence, fluorescein angiography, indocyanine-green angiography, fundus photo and microperimetry. Patients are re-examined after an interval of 6 weeks until subretinal fluid is entirely reabsorbed to gain further insides in etiology, course and prognosis of this disease.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Age over 18 years
* acute episode of Central Serous Chorioretinopathy
* Symptoms for less than two weeks
* no treatment on study eye

Exclusion Criteria:

* bad compliance
* protected patient group (pregnant women)

Primary outcomes:
measure: Clinical Outcome
timeFrame: 2 years
Secondary outcomes:
measure: Subclinical Data
timeFrame: 2 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Gerenal Hospital
Study officials:
affiliation: Department of Ophthalmology, Medical University of Vienna, Austria
name: Stefan Sacu, Ass.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00708630: The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination
Official title: The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Keywords: yellow fever vaccine
patient information
symptom reports
patient satisfaction
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2008-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to investigate the effect of providing additional information about possible mild side effects of the yellow fever vaccination on the reporting of physical symptoms. Additionally, the project aims to investigate the relationship between individual characteristics (trait anxiety and perceived sensitivity to medication) and the reporting of physical symptoms, as well as possible interactions between the level of information provided and individual characteristics. We hypothesize that more information about mild symptoms provided to participants will increase the number of reported symptoms after vaccination.


Eligibility criteria: Inclusion Criteria:

* Receiving yellow fever vaccination
* English speaker
* Aged over 18

Exclusion Criteria:

* No phone for follow-up

Primary outcomes:
measure: symptom report scale
timeFrame: 20 minutes and 1 week post vaccination
Secondary outcomes:
measure: patient satisfaction scale
timeFrame: 20 minutes and 1 week post vaccination
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Worldwise Travellers Health
Study officials:
affiliation: University of Auckland, New Zealand
name: Keith J Petrie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Auckland, New Zealand
name: Kate E Faasse, BSc
role: PRINCIPAL_INVESTIGATOR
References: