louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01850849: Safety, Tolerability and Pharmacokinetics in AD Subjects and Healthy Subjects of Cutaneous Application of LEO 39652 Cream
Official title: A Phase I, First-in-Human, Vehicle Controlled, Single Ascending Dose Trial Evaluating the Safety, Tolerability and Pharmacokinetics in Male Subjects With AD and in Healthy Male Subjects of Cutaneous Application of LEO 39652 Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2013-05-10
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic dermatitis and to healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects or subjects with AD as defined by the Hanifen and Rajka criteria and with at least mild disease activity (IGA \>2) for the whole body
* AD lesions amenable to cutaneous treatment located on the trunk and/or limbs (only for AD subjects)
* Male subjects aged between 18 and 65 years with a body mass index (BMI) between 19.0 and 32.0 kg/m2 inclusive

Exclusion Criteria:

* Subjects who currently suffer from, or show signs of eczema or other skin lesions (only for healthy subjects)
* Subjects who are still participating in a clinical trial (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational product or a marketed drug product within the past 3 months prior to the first dosing occasion.
* Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.
* History of or current cardiac arrhythmic disorder
* Subjects with a current active malignancy or a history of malignancy in remission for less than 5 years except excised skin (not melanoma) and cervical cancer.
* Subjects who have any clinically significant allergic disease (excluding non- active hayfever) as determined by the Investigator

Primary outcomes:
measure: Number of subjects with adverse events and change from baseline in vital signs (blood pressure, pulse rate) ECG, clinical laboratory and local tolerability assessments
timeFrame: Up to 48 hours after dosing
Secondary outcomes:
measure: LEO 39652 and metabolites in blood
timeFrame: Up to 48 hours after dosing
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit, Hyde Street, Leeds, UK
city: Liverpool
country: United Kingdom
facility: Covance Royal Liverpool Clinical Research Unit
Study officials:
affiliation: Covance Clinical Research Unit, Hyde Street, Leeds, UK
name: Joseph Chiesa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01564706: A Study of 18F-AV-45 in Healthy Volunteers
Official title: Positron Emission Tomography Whole Body Biodistribution Using 18F-AV-45
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Keywords: Amyloid imaging
Positron Emission Tomography
18F-AV-45
florbetapir F 18
Diagnostic imaging
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.


Eligibility criteria: Inclusion Criteria:

* Able to lie still on the imaging table for periods up to 1 hour

Exclusion Criteria:

* Radiation exposure for experimental purposes within the last year
* Claustrophobic or otherwise unable to tolerate the imaging procedure
* Medical condition or surgical history that would confound evaluation
* Current clinically significant cardiovascular disease
* Received an investigational medication within the last 30 days

Primary outcomes:
measure: Whole Body Radiation Dosimetry
timeFrame: 0-380 min after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Jenkintown
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: Avid Radiopharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT01750606: An MRI Investigation of Soft Tissues in Total Hip Arthroplasty
Official title: An MRI Investigation of Soft Tissues in Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tissue Reaction
Elevated Blood Ion Levels
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 436
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received the indicated implants at one of four participating centers and who meet the sampling plan requirements.

Brief summary: Retrospective study to comply with FDA's post-market surveillance order. The purpose of the study is to contact patients who have received a Biomet metal-on-metal product as their primary total hip arthroplasty device. Patients who have not been revised prior to contact will be asked to submit to a blood draw, clinical exam and MRI.

Detailed description: This study has been designed to estimate the prevalence of soft tissue changes following primary THA surgery in patients having received one of five Biomet implant types; a MOP primary THA, an M2a 38, M2a Taper, M2a Ringloc and M2a Magnum MOM primary THA device in 308-436 total patients at four centers.

The primary objective of the study is to estimate the prevalence of soft tissue changes in unbiased MoM and MoP samples. Secondary objectives are to evaluate whether the occurrence of soft tissue changes is related to any of several potential covariates including patient and implant characteristics and time in situ.

Eligibility criteria: Inclusion Criteria:

* patient meets the sampling plan requirements

Exclusion Criteria:

* patient is contraindicated for MRI
* patient fails to consent for the study

Primary outcomes:
measure: Number of symptomatic and asymptomatic Metal-on-Metal and Metal-on-Poly patients (via a proportion) with a soft tissue mass
timeFrame: patients 3 years post-implantation up to 6 years post implantation
Secondary outcomes:
measure: Metal ion concentrations in whole blood and serum
timeFrame: 1-10 year post implantation, depending on cohort
Other outcomes:
Locations:
city: Flint
country: United States
facility: Ortho Michigan
state: Michigan
city: New Albany
country: United States
facility: Joint Implant Surgeons
state: Ohio
city: Columbia
country: United States
facility: Midlands Orthopaedics
state: South Carolina
city: Plano
country: United States
facility: Texas Center for Joint Replacement
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Zimmer Biomet
name: Russell Schenck, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00545506: The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery
Official title: The Influence of a Warmed Surgical Bandage System on Subcutaneous Tiisue Oxygen Tension After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Surgery
Keywords: wound infection
tissue oxygen tension
local warming
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Outcomes Research Consortium
First posted: 2007-10-17
Enrollment: 6
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: BASIC_SCIENCE

Brief summary: Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound infections

Detailed description: Wound infections are common and serious complications of anesthesia and surgery. The morbidity associated with surgical infections is considerable and includes substantial prolongation of hospitalization.

The wound infection risk in patients undergoing cardiac surgery ranges from 0.8 to 17.7% including both superficial and deep sternal infections.

Major factors influencing the incidence of surgical wound infection other than site and complexity of surgery, underlying illness, timely administration of prophylactic antibiotics, intraoperative patient temperature, hypovolemia and tissue oxygen tension. The primary determinant of tissue oxygen availability is local perfusion. Thermoregulatory status is one of the major factors influencing tissue perfusion. Local warming induces pre- capillary vasodilation and improves tissue oxygenation. Local warming of surgical wounds may provide a simple and inexpensive way to reduce perioperative wound complications. Specifically, we will test the hypothesis that Warm- Up therapy increases postoperative tissue oxygen tension in patients undergoing cardiopulmonary bypass.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years of age scheduled for elective cardiac surgery on normothermic cardio-pulmonary bypass will be invited to participate

Exclusion Criteria:

* Emergency surgery
* Pre - or postoperative on intraaortic balloon pump
* Preoperative mechanical ventilation
* Postoperative respiratory failure
* Postoperative extracorporal membrane oxygenation
* Left ventricular function \< 40%
* Fever (core temperature \> 38 °C) or current infection
* No anticipated or no definitive primary closure of surgical wound.

Primary outcomes:
measure: Tissue Oxygen Tension in the Sternal Wound
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University Vienna,Spitalgasse 23, 1090 Vienna, Austria
name: Barbara Kabon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University Vienna, Spitalgasse 23, 1090 Vienna, Austra
name: Helmut Hager, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01127906: Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo And Active Comparator Controlled 4-Period Cross-Over Study To Assess The Effect Of PF-04531083 On Heat Pain In The UVB-Induced Pain Model In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
cross-over
randomized
placebo and active controlled
heat pain
UVB-Induced pain model
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 36
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: PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. This study is designed to see if this is also true in man.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers.
* Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg.

Exclusion Criteria:

* Subjects that have any condition possibly affecting drug absorption (eg, gastrectomy).
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Subjects with inadequate cardiac function (ECG demonstrating prolonged QTc interval at screening).
* Subjects with inadequate or excessive sensitivity to UVB light.

Primary outcomes:
measure: To assess the effect of PF-04531083 by using the Heat Pain Tolerance Threshold in the area of UVB-induced erythema (HPTTu) endpoint at 2, 4, 6 and 24 hours.
timeFrame: 24 hours
Secondary outcomes:
measure: Heat Pain Perception Threshold in the area of UVB-induced erythema (HPPTu) at 2, 4, 6 and 24 hours.
timeFrame: 24 hours
measure: Heat Pain Perception Threshold on control skin (HPPTc) at 2, 4, 6 and 24 hours
timeFrame: 24 hours
measure: Summary of plasma concentrations of PF-04531083
timeFrame: 24 hours
measure: Exploratory colorimetric data collected from baseline and MED test exposure areas
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01593306: Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carcinoma Cervix
Lead sponsor: Indira Gandhi Medical College, Shimla
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 80
Sex: FEMALE
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 purpose of this study is to check whether addition of paclitaxel to cisplatin and radiation therapy will improve the outcome in locally advanced carcinoma cervix.

Detailed description: Carcinoma cervix is the 2nd most common malignancy among females and about 86% of this burden occurs in developing countries. India accounts for 27% of world cervical cancer burden; and most of them are of locally advanced stage ie stage IIA to IVA.

Significant development in radiation techniques and addition of cisplatin based chemotherapy to radiation schedule has led to improved survival but still it is far from satisfactory with 20 to 25% patients failing locally while 10 to 20% patients fail at distant sites. Novel techniques are required to improve this dismal rate.

Thus investigators intended to use combination chemotherapy with paclitaxel and cisplatin, considering that paclitaxel is a taxane which has shown good efficacy in other solid tumors such as ovary, lung and breast; it has also shown radiosensitizing effect in cervical cancer cell lines and it has also been shown to be effective in phase III trials with cisplatin in metastatic and recurrent carcinoma cervix.

Eligibility criteria: Inclusion Criteria:

* histologically proven carcinoma cervix
* age 18 years to 65 years
* stage IIA, IIB, IIIA \& IIIB according to FIGO 2009

Exclusion Criteria:

* age \> 65 years and \< 18 years
* stage IA, IB, IVA \& IVB
* Histology other than squamous cell, adenocarcinoma or adenosquamous carcinoma
* history of prior pelvic surgery for cancer, prior pelvic radiotherapy or prior chemotherapy.
* deranged renal function test and liver function test
* KPS \>= 60
* distant metastasis

Primary outcomes:
measure: clinical response of the disease
timeFrame: up to 1 year
Secondary outcomes:
measure: number of patients with adverse events
timeFrame: during treatment, 14 weeks
Other outcomes:
Locations:
city: Shimla
country: India
facility: Indira Gandhi Medical College
state: Himachal Pradesh
Study officials:
affiliation: Indira Gandhi Medical College, Shimla
name: Pragyat Thakur, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thakur P, Seam R, Gupta M, Gupta M. Prospective randomized study comparing concomitant chemoradiotherapy using weekly cisplatin & paclitaxel versus weekly cisplatin in locally advanced carcinoma cervix. Ann Transl Med. 2016 Feb;4(3):48. doi: 10.3978/j.issn.2305-5839.2015.11.19.
Clinical trial NCT04673006: Risk of Bacterial Exposure to the Anesthesiologist's Face During Intubation and Extubation
Official title: Risk of Bacterial Exposure to the Anesthesiologist's Face During Intubation and Extubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesiologists Who Perform Endotracheal Intubation and Extubation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All anesthesiologists who perform endotracheal intubation and extubation will be included in this study. This study will be done only in patients who are scheduled for endotracheal intubation for elective surgeries.

Brief summary: The practice of intubation and extubation is not without risks to the anesthesiologists. Especially, the face of health care worker is the body part most commonly contaminated by splashes and sprays of body fluids. The aim of this study is to determine the incidence of unrecognized exposure to the anesthesiologists' face during endotracheal intubation and extubation. We will perform face shield swab before and after the endotracheal intubation and extubation. All swabs will be cultured for 48 hours and the number of colony forming units before and after the procedures (intubation/extubation) will be compared.


Eligibility criteria: Inclusion Criteria:

* anesthesiologists who perform endotracheal intubation and extubation for patients scheduled for endotracheal intubation for elective surgeries

Exclusion Criteria:

* none

Primary outcomes:
measure: Bacterial growth of face shield swab after the endotracheal extubation
timeFrame: Bacterial swab will be performed 5 minutes after the endotracheal extubation (after the confirmation of sufficient spontaneous breathing)
Secondary outcomes:
measure: Bacterial growth of face shield swab after the endotracheal intubation
timeFrame: Bacterial swab will be performed 5 minutes after the endotracheal extubation (after the confirmation of adequate mechanical ventilation)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Seung Hyun Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02437006: Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke
Official title: Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
exercise capacity
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a two-stage study. In the first stage, 30 subjects with stroke (onset \> 2 weeks) are recruited, and they are assessed and recorded with clinical characteristics, sympathetic nerve testing, and twice symptom-limit exercise capacity tests. The second stage would recruited 90 subjects with stroke (onset\>2 weeks), and they are randomized to one of three groups (control, low-intensity, high-intensity). They are evaluated before and after the four-week interval with clinical characteristics and twice symptom-limit exercise capacity tests (baseline and after four-week training) .

Detailed description: This is a two-stage study. In the first stage, 30 subjects with stroke (onset \> 2 weeks) are recruited, and they are assessed and recorded with sympathetic nerve testing, anthropometry, and twice symptom-limit exercise capacity tests.The second stage would recruited 90 subjects with stroke (onset\>2 weeks), and they are randomized to one of three groups. The control group undergoes traditional rehabilitation only, The low-intensity exercise group receives a low-intensity four-week cycle ergometry and traditional rehabilitation. The The high-intensity exercise group gets a high-intensity four-week cycle ergometry and traditional rehabilitation. They are evaluated by sympathetic tests, anthropometry, functional scales and activity questionnaires, and symptom-limit exercise capacity tests before and after the four-week training.

Eligibility criteria: Inclusion Criteria:

* stroke onset longer than two weeks,
* eligible for exercise testing by Doctor

Exclusion Criteria:

* aphasia,
* apraxia

Primary outcomes:
measure: change values of symptom-limit exercise capacity
timeFrame: baseline and after four-week training
Secondary outcomes:
measure: change values of sympathetic nerve tests
timeFrame: baseline and after four-week training
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University, College of Health Sciences
Study officials:
affiliation: Kaohsiung Medical University, College of Health Sciences
name: Miao-Ju Hsu, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00199706: HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients
Official title: 7.2% NaCl in 6% Hydroxyethyl Starch Versus Placebo - Effect on Intracranial Pressure and Haemodynamics in Subarachnoidal Haemorrhage (SAH) Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Subarachnoid Hemorrhage
Keywords: Intracranial Pressure
Intracranial Hypertension
Hypertonic Solutions
Saline Solutions, Hypertonic
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 20
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 determine whether 7.2% NaCl in 6% hydroxyethyl starch will lower intracranial pressure (ICP) in SAH-patients with normal or moderately elevated ICP in a placebo controlled study, and to describe the haemodynamic effects.

Detailed description: In the acute phase after a SAH, many patients need intensive care treatment to control the development of fatally increased intracranial pressure. One type of treatment used is osmotherapy. Traditionally mannitol has been the preferred drug, but the use of hypertonic saline solutions has gained more and more acceptance. The immediate effect seems to be equivalent or better than with mannitol, and there seem to be less adverse effects, such as hypovolemia, acute renal failure, hyponatremia, and rebound increase of ICP.

Most clinical studies in patients with life-threatening increase in ICP are observational, and show a predictable effect of hypertonic saline. We wanted to strengthen our own findings from such a study by applying the same study model but with a placebo control group in patients with only moderately elevated ICP.

We also wanted to document the haemodynamic effects, measuring cardiac output, intrathorasic blood volume and extravascular lung water.

Eligibility criteria: Inclusion criteria:

* Subarachnoid Hemorrhage, source of bleeding radiologically or surgically secured
* Age \> 18 years
* Mechanically ventilated
* Sedated
* Stable hemodynamics
* Stable intracranial pressure between 10 - 20 mmHg

Exclusion criteria:

- Serum sodium \> 160 mmol/l

Primary outcomes:
measure: Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period
Secondary outcomes:
measure: Changes in cerebral perfusion pressure (CPP) measured as AUC
measure: changes in cardiac output
measure: intrathorasic blood volume
measure: extravascular lung water
measure: serum sodium levels during the 210 minutes trial period
Other outcomes:
Locations:
Study officials:
affiliation: Oslo University Hospital
name: Gunnar Bentsen, MD
role: PRINCIPAL_INVESTIGATOR
References: