louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01417715: Endomicroscopy for Assessment of Mucosal Healing
Official title: Advanced Endoscopic Imaging Using Endomicroscopy for Assessment of Mucosal Healing in IBD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn´s Disease
Ulcerative Colitis
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 Crohn´s disease and ulcerative colitis in the active and quiescent phase of the disease.

Brief summary: Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.

The main objective of this study is to determine endomicroscopic features of mucosal healing in patients with IBD.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing colonoscopy

Exclusion Criteria:

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Residing in institutions (e.g. prison)
* Known allergy against fluorescein
* Proctocolectomy

Primary outcomes:
measure: Mucosal healing
timeFrame: up to three years
Secondary outcomes:
measure: Histologic correlation
timeFrame: up to three years
measure: Therapeutic effect
timeFrame: up to three years
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen-Nuremberg
Study officials:
affiliation: Department of Medicine I, University of Erlangen-Nuremberg, Germany
name: Helmut Neumann, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine I, University of Erlangen-Nuremberg, Germany
name: Markus F. Neurath, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00685815: Intravenous Iron Metabolism in Restless Legs Syndrome
Official title: Intravenous Iron Metabolism in Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Restless Legs
Keywords: IV Iron
Restless Legs Syndrome
RLS
Iron
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2008-05-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome

Detailed description: To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Restless Legs Syndrome (RLS).
* Presence of increased periodic leg movements of sleep (PLMS) before receiving treatment.
* Patient sleep times are between 9pm and 9am.
* Patient's RLS symptoms would occur daily if you were not on medication.

Exclusion Criteria:

* RLS secondary to other medical disorders as determined by history and physical/neurological examination.
* On a treatment (e.g., psychiatric medication) that might significantly alter RLS symptoms or study results and who cannot discontinue medication for the extended period of the study.
* History of multiple adverse drug reactions or specifically an allergy to IV iron.
* Currently experiencing a serious medical condition (chronic organ failure, active inflammation or infection, congestive heart failure, etc.) that might alter iron metabolism, would place them at risk, or interfere with study participation.
* An magnetic resonance imaging (MRI) is not possible because of medical reasons (Pacemaker; loose iron in the tissue) or concern about severe claustrophobia.
* Any condition that is likely to increase iron loss (chronic bleeding, excluding menstruation; medically necessary phlebotomy) or consumption (pregnancy).
* Serum ferritin \>300mg/L or percent iron saturation \>50%. This is to exclude subjects with probable hemochromatosis.
* Significant medical (e.g., inflammatory bowel syndrome; bowel dysmotility syndromes) or surgical (e.g., gastrojejunal bypass, colectomy) GI tract problems; and active chronic inflammatory processes (e.g., active hepatitis, rheumatoid arthritis, systemic lupus erythematosus). This is to exclude conditions which will potentially alter iron metabolism.

Primary outcomes:
measure: Duration Off Treatment
timeFrame: 2 weeks, 4 weeks, and 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Christopher J. Earley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139515: Eletriptan Pharmacokinetics In Korean Males
Official title: An Open Label, Single And Repeat Dose Randomized Crossover Study To Estimate The Pharmacokinetics And Safety Of Eletriptan Hydrobromide Tablets In Healthy Korean Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetic
eletriptan
Korean
crossover
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-08
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The hypothesis of this study is that Korean subjects have similar Pharmacokinetics (PK) characteristics to those seen in other populations.


Eligibility criteria: Inclusion Criteria:

* healthy male subjects, 18-55 years old
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
* provide informed consent

Exclusion Criteria:

* blood pressure \>140/90 mm Hg
* any condition possibly affecting drug absorption
* positive urine drug screen

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
timeFrame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D)
measure: AUC From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
Secondary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
measure: Plasma Decay Half Life (t1/2)
timeFrame: Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04143815: Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines
Official title: PhaseII, Randomized, Double-blind, Placebo Controlled, Multi-center, Dose-ranging and Open Label Extension Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Frown Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-10-29
Enrollment: 200
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: This study will determine the effect of MBA-P01 in subjects with glabellar lines at a range of doses compared with placebo.

This study includes two treatment period; 1) Dose-ranging period, Day0 to 16weeks and 2) Open-label extension period, 16 weeks to 52.


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years of age
* Bilaterally symmetrical moderate to severe GL at maximum frown as assessed by both investigator and subject using FWS

Exclusion Criteria:

* History of facial nerve paralysis
* Any eyebrow or eyelied ptosis as determined by the investigator

Primary outcomes:
measure: Facial Wrinkle Scale(FWS) change
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maroubra
country: Australia
facility: Maroubra MEdical Centre
state: New South Wales
Study officials:
References:
Clinical trial NCT04319315: Social Media Effect on Knowledge Dissemination During COVID-19 Virus Outbreak
Official title: Impact of Social Media on Knowledge Dissemination Between Physicians During COVID-19 Virus Outbreak
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Corona Virus
Social Media
Physician
Knowledge
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 400
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study survey will be distributed through email to medical physicians in our territory

Brief summary: The recent COVID-19 outbreak is very challenging as data are distributed instantly on the data are very rapidly distributed through professional and non professional sources which may impact the management of the disease

Detailed description: The investigators are conducting a survey between the physicians to study the effect and practice of received knowledge disseminated through social media .

the survey will be distributed through internet and data will be collected and analyzed

Eligibility criteria: Inclusion Criteria:

* Medical Physicians in Middle East area

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of physicians affected by social media measured by online survey designed to measure the influence of social media on medical practice
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
Study officials:
affiliation: Assiut University
name: Aliae Mohamed-Hussein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04726215: Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer
Official title: Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1 Directed Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: CellSight Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study using \[18F\]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors at multiple study sites. The main objectives of the study are to quantify the change in \[18F\]F AraG PET signal before and after CkIT therapy, and to correlate this change in \[18F\]F AraG PET signal with a radiographic response.

Detailed description: Approximately 50 patients will undergo two research PET/CT scans with \[18F\]F AraG at two time points. Each patient will receive two 5 (+/-10%) mCi doses of \[18F\]F AraG, one for each imaging time point. Eligible subjects will undergo a pre-treatment \[18F\]F AraG PET/CT scan within 7 days prior to treatment, followed by treatment, and an on-treatment \[18F\]F AraG PET/CT within 7-14 days of treatment.

Objectives:

* Quantify \[18F\]F-AraG uptake in advanced NSCLC tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in patients treated with standard of care immunotherapy (as monotherapy or part of combination therapy).
* Correlate change in \[18F\]F AraG uptake in tumor lesions with radiographic response.

Eligibility criteria: Inclusion Criteria:

1. Patients with a histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy with concurrent as treatment for advanced/metastatic disease.
2. RECIST measurable disease.
3. ECOG performance status of 0, 1 or 2.
4. Life expectancy \>/= 6 months at enrollment.

Exclusion Criteria:

1. Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
2. Pregnant women or nursing mothers.
3. Patients with severe claustrophobia.

Primary outcomes:
measure: [18F]F-AraG uptake signal
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Veterans Institute of Research
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: CellSight Technologies, Inc.
name: Deepak Behera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02124915: Influence of Socket Volume on Prosthesis Performance
Official title: Influence of Socket Volume on Prosthesis Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Limb Amputation Below Knee (Injury)
Keywords: prosthetic socket
amputee
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-04-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transtibial amputees

Brief summary: The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis use, perceived comfort, and satisfaction with the prosthesis are affected by size of the prosthetic socket. Subjects are tested after wearing a nominal socket for 1 month and again after wearing a slightly oversized socket for 1 month.


Eligibility criteria: Inclusion Criteria:

* transtibial amputee
* at least 18 months post amputation
* over 18 years of age
* capable of treadmill walking and 90 seconds of continuous standing

Exclusion Criteria:

* skin breakdown on the residual limb

Primary outcomes:
measure: Residual limb fluid volume
timeFrame: 1 month
Secondary outcomes:
measure: Activity
timeFrame: 1 month
Other outcomes:
measure: Comfort and prosthesis satisfaction
timeFrame: 1 month
measure: Gait
timeFrame: 1 month
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT00977015: Study To Estimate The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
Official title: An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-15
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Pregnant or nursing females.

Primary outcomes:
measure: Plasma pharmacokinetic parameters: AUClast and Cmax
timeFrame: 48
Secondary outcomes:
measure: Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life.
timeFrame: 48
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02751515: Human Photoallergy Test
Official title: Human Photoallergy Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the potential of a test material to produce a photoallergic response.


Eligibility criteria: Inclusion Criteria:

* Be male or female between the ages of 18 and 60 inclusive
* Be lightly pigmented (Fitzpatrick Skin Type I, II, III)
* Have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164
* Be in general good health as determined by the subject's medical history and in the discretion of the investigator

Exclusion Criteria:

* Have a visible sunburn
* Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses
* Have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products
* Subjects who are employees of the Contract Research Organization (CRO) and/or Bayer or is a household member of an employee

Primary outcomes:
measure: Intensity of skin reactions is evaluated by 5 point scale
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00548015: Helping Hands: Promoting Hand Hygiene in Hospital Nurses
Official title: HELPING HANDS: a Comparison of Short- and Long Term Effects of Alternative Strategies for Promoting Hand Hygiene in Hospital Nurses.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Handwashing
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2007-10-23
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hand hygiene prescriptions are the most important measure in the prevention of hospital acquired infections. Yet compliance rates are generally below 50% of all opportunities for hand hygiene adherence. This study will test the short- and long term effects of two strategies for promoting hand hygiene in hospital nurses


Eligibility criteria: Inclusion Criteria:

* Hand hygiene opportunities at the point of patient care

Exclusion Criteria:

* Hand hygiene opportunities not concerning patient care like personal hygiene

Primary outcomes:
measure: Percentage of adherence of opportunities for hand hygiene
timeFrame: march 2008, october 2008, may 2009, november 2009
Secondary outcomes:
measure: Team climate, Cost effectiveness
timeFrame: december 2008, june 2009
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre, PObox 9101
city: Tilburg
country: Netherlands
facility: Elisabeth Ziekenhuis
Study officials:
affiliation: Centre for Quality of Care Research
name: Theo van Achterberg, PhD RN
role: STUDY_CHAIR
References:
citation: Huis A, Holleman G, van Achterberg T, Grol R, Schoonhoven L, Hulscher M. Explaining the effects of two different strategies for promoting hand hygiene in hospital nurses: a process evaluation alongside a cluster randomised controlled trial. Implement Sci. 2013 Apr 8;8:41. doi: 10.1186/1748-5908-8-41.
citation: Huis A, Hulscher M, Adang E, Grol R, van Achterberg T, Schoonhoven L. Cost-effectiveness of a team and leaders-directed strategy to improve nurses' adherence to hand hygiene guidelines: a cluster randomised trial. Int J Nurs Stud. 2013 Apr;50(4):518-26. doi: 10.1016/j.ijnurstu.2012.11.016. Epub 2012 Dec 13.
citation: Huis A, Schoonhoven L, Grol R, Donders R, Hulscher M, van Achterberg T. Impact of a team and leaders-directed strategy to improve nurses' adherence to hand hygiene guidelines: a cluster randomised trial. Int J Nurs Stud. 2013 Apr;50(4):464-74. doi: 10.1016/j.ijnurstu.2012.08.004. Epub 2012 Aug 28.
citation: Huis A, Schoonhoven L, Grol R, Borm G, Adang E, Hulscher M, van Achterberg T. Helping hands: a cluster randomised trial to evaluate the effectiveness of two different strategies for promoting hand hygiene in hospital nurses. Implement Sci. 2011 Sep 3;6:101. doi: 10.1186/1748-5908-6-101.