louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01567657: Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography
Official title: Phase II Study of Comparison of Two Sedation Regimen for Transesophageal Echocardiography in Point of View of Blood Pressure Response, Safety and Patient Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypotension
Keywords: Sedation in TEE
Blood pressure drop during TEE
Safety of sedation in TEE
Lead sponsor: Kantonsspital Münsterlingen
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine whether sedation with a combination of pethidin hydrochlorid plus midazolam intravenously (i.v.) is superior to propofol i.v. alone in relation to blood pressure drops during an transesophageal echocardiographic examination (TEE).

Detailed description: Randomisation is done immediately after information of the patient and obtaining of the informed consent. The average time for a TEE study is about 30 minutes. Data collection occurs during this time frame. ECG monitoring and data collection (blood pressure, heart rate, SO2) for the study protocol starts 6 minutes before the application of the sedation. At -6, -4, -2 minutes before the application of the sedation, baseline data are collected. The average systolic blood pressure of these three measures is taken as the reference blood pressure. This is the reference value to calculate the blood pressure drop during the examination. Blood pressure, pulse oxymetry, heart rate are taken every 2 minutes until the examination (TEE) is finished. The questionnaire (for second end points) is filled out by the patient within two hours after the examination. The patient will be followed for the duration of about one hour after the examination, if he is from the outpatient clinic. Patients from the hospital (inpatients) will be followed routinely in the clinic.

Eligibility criteria: Inclusion Criteria:

* all patients scheduled for TEE in our department who have signed the informed consent except those younger than 18 years and patients with a second or third etc. TEE

Exclusion Criteria:

* \< 18 years
* intensive care patients
* emergency department patients
* breast feeding women
* pregnant women
* patients with an allergy to Propofol or its ingredient soy oil, Pethidin or Midazolam

Primary outcomes:
measure: Number of patients with a blood pressure drop of more than 30 mmHg and below 100 mmHg systolic
timeFrame: During examination (TEE), expected to be ca. 30 minutes
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: At time of transfer to the ward, expected to be after ca. 1 hour
Other outcomes:
Locations:
city: Münsterlingen
country: Switzerland
facility: Kantonsspital Münsterlingen
state: Kanton Thurgau
Study officials:
affiliation: Departement of Cardiology, Kantonsspital Münsterlingen
name: Fritz Widmer, Dr. med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01201057: Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
Official title: A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Vaginosis
Keywords: SPL7013
VivaGel
bacterial vaginosis
BV
Lead sponsor: Starpharma Pty Ltd
Sponsor class: INDUSTRY
First posted: 2010-09-14
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-45 years with a diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
* Otherwise healthy

Exclusion Criteria:

* No active STIs

Primary outcomes:
measure: Number of Women With Clinical Cure as a Measure of Efficacy
timeFrame: Day 21-30
Secondary outcomes:
measure: Number of Women With Clinical Cure as a Measure of Efficacy
timeFrame: Day 9-12
measure: Number of Women With Nugent Cure as a Measure of Efficacy
timeFrame: Day 9-30
measure: Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)
timeFrame: Day 9-30
measure: Incidence of Genital Adverse Events Potentially Related to Treatment
timeFrame: For the duration of the study (up to Visit Day 21-30)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Irving
country: United States
facility: Bexar Clinical Trials, LLC
state: Texas
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research Inc
state: Virginia
Study officials:
affiliation: contracted to Starpharma Pty Ltd
name: Anne Macek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03814057: Creatinine Height Index in Elderly
Official title: Age- Adjusted Measurements of Creatinine Height Index for Diagnosing Malnutrition in Elderly Medical Patients at Hospital Admission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition in Elderly
Keywords: Anthropometric measurements,
creatinine height index
lean body mass
Mini- nutritional assessment
Hand Grip strength
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly Medical Patients at hospital admission with exclusion of factors might affect 24 hour urine collection or urinary creatinine excretion

Brief summary: evaluation of the efficacy of two different age adjusted calculations of CHI compared to other nutritional indicators in the elderly medical patients upon hospital admission.

Detailed description: Cross sectional study involving one hundred hospitalized elderly (\>60 years), Anthropometric measurements, Mini- nutritional assessment, Hand Grip strength, CBC, total protein, albumin, total cholesterol, triglyceride, and 24 hour urinary creatinine excretion were measured within 24 hours of hospital admission calculation of CHI using 2 age adjusted modification was done accuracy of each measurement in detecting malnutrition was evaluated

Eligibility criteria: Inclusion Criteria:

* medical elderly patients (\>60 years)
* within 24 hours of hospital admission

Exclusion Criteria:

* sepsis
* fever
* malignancy
* liver cirrhosis
* renal impairment
* critically ill patients
* those with any hemodynamic instability were excluded from the study
* patients receiving diuretics
* patients can't stand to obtain their weight and height
* those can't collect 24 hour urine
* the patients refused to participate in the study

Primary outcomes:
measure: accuracy of creatinine height index in Elderly
timeFrame: within 24 hours of hospital admission
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: DOHA RASHEEDY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02404857: BCI Post-stroke Neurorehabilitation
Official title: A Novel BCI-controlled Pneumatic Glove System for Neurorehabilitation Post-stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poststroke/CVA Hemiparesis
Paralytic Stroke
Hand Flaccid Paralysis
Keywords: Post stroke
BCI
Reeducation
Hand movement
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Université Montpellier
name: National University of Ireland, Maynooth
name: Centre Hospitalier Universitaire de Nīmes
First posted: 2015-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke.

Detailed description: Brain computer interfaces (BCI) encompasses the usage of the brain signals to compensate for lost physical function. The current protocol evaluates the therapeutic potential of a EEG based driven BCI that is connected to a non-invasive pneumatic glove for rehabilitation of hand flexion/extension post-stroke. The system non-invasive, portable and low-cost. The utility and usability of the system will be investigated at two levels. First by means of questionnaires for patients and therapist and second by means of in depth analysis of the EEG signals during intended, imagined and passive driven hand movements in relation to no movement at all and the capacity of the BCI to distinguish between these conditions.

Eligibility criteria: Inclusion Criteria:

* \> 6 months post-stroke (chronic), unilateral
* \> 18 yrs
* little to no hand movement
* spasticity \< 3 on modified Ashworth Scale

Exclusion Criteria:

* major cognitive deficits (Folstein mini mental status \> 23
* strong hemi-neglect (Catherine Bergego scale \> 15/30)

Primary outcomes:
measure: Performance of the BCI-system (evaluation of performance through patient questionaires & the performance of the BCI classifier during intended and imagined hand movements)
timeFrame: During the whole study. Assesment is made for each patient after his participation ( 2 hours).
Secondary outcomes:
measure: EEG sensory-motor rhythm signals (Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition)
timeFrame: During the whole studyAssesment is made for each patient after his participation ( 2 hours).
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU Lapeyronie
state: Herault
Study officials:
affiliation: CHRU Montpellier, Lapeyronie // Euromov-M2H, Montpellier University
name: Liesjet Van Dokkum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04769557: Pre Emptive Analgesics for Pain Relief in Impacted Lower Third Molar Surgery
Official title: Pre-emptive Analgesics for Additional Pain Relief in Impacted Third Molar Surgery by depositing4% Articaine With 1:200000 Epinephrine Using Vazirani-Akinosi Closed Mouth Technique- A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impacted Third Molar Tooth
Lead sponsor: Melaka Manipal Medical College
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate the efficacy of pre-emptive paracetamol in reducing intra operative pressure and post operative pain after surgical removal of impacted mandibular third molar using visual analogue scale


Eligibility criteria: Inclusion Criteria:

* Patients aged 21 years and above
* Healthy patients (ASA I)
* Patients who are not allergic to the drugs and local anesthetic agents used

Exclusion Criteria:

* Patients who are on concurrent treatment with NSAIDs or corticosteroids
* Patients with pericoronitis or periapical infection

Primary outcomes:
measure: intraoperative pain
timeFrame: during luxation of tooth
measure: postoperative pain
timeFrame: 1 day
Secondary outcomes:
measure: Time to rescue medication
timeFrame: upto 360 minutes
measure: number of patients taking rescue medications
timeFrame: Upto 360 minutes
Other outcomes:
Locations:
city: Melaka
country: Malaysia
facility: Melaka manipal medical college
Study officials:
affiliation: Melaka Manipal Medical College
name: Abdul K azad, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01732757: A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Conjunctivitis, Allergic
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-11-26
Enrollment: 157
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* History of ocular allergies within the past 24 months.
* Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.

Exclusion Criteria:

* Any presence of active ocular infection or history of an ocular herpetic infection.
* Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.
* Have any planned surgery during the study or 30 days after the study.

Primary outcomes:
measure: Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0
timeFrame: Day 0 at 3 Minutes Post Challenge
Secondary outcomes:
measure: Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0
timeFrame: Day 0
measure: Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0
timeFrame: Day 0
measure: Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0
timeFrame: Day 0
measure: Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0
timeFrame: Day 0
measure: Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
timeFrame: Day 0
measure: Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
timeFrame: Day 0
measure: Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
timeFrame: Day 0
measure: Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
timeFrame: Day 0
measure: Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
timeFrame: Day 0
measure: Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
timeFrame: Day 0
Other outcomes:
Locations:
city: Memphis
country: United States
state: Tennessee
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: McLaurin EB, Marsico NP, Ackerman SL, Ciolino JB, Williams JM, Villanueva L, Hollander DA. Ocular itch relief with alcaftadine 0.25% versus olopatadine 0.2% in allergic conjunctivitis: pooled analysis of two multicenter randomized clinical trials. Adv Ther. 2014 Oct;31(10):1059-71. doi: 10.1007/s12325-014-0155-3. Epub 2014 Sep 27.
Clinical trial NCT03669757: Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis
Official title: A Phase 1b, Randomised, Controlled, Observer-blinded Trial to Assess Safety, Tolerability and Pharmacodynamic Effects of LEO 134310 Cutaneous Solution in Descaled Skin of Adults With Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2018-09-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-individual comparison of all treatment
Primary purpose: TREATMENT

Brief summary: To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.


Eligibility criteria: Inclusion Criteria:

* Subjects aged 18-64 years (inclusive) with plaque psoriasis in a chronic stable phase.
* Men or women of non-child bearing potential.

Exclusion Criteria:

* Acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.
* According to defined washout periods: topical antipsoriatic drugs (except salicylic acid in petroleum jelly); systemic antipsoriatics and biologics; ultraviolet (UV) therapy.

Primary outcomes:
measure: Overall number of treatment-emergent adverse events.
timeFrame: Up to Day 19
measure: Number of treatment-emergent application site reactions, by treatment.
timeFrame: Up to Day 19
measure: Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters
timeFrame: Up to Day 12
measure: Change from baseline to Day 4, Day 8 and Day 12 in clinical chemistry parameters
timeFrame: Up to Day 12
measure: Change from baseline to Day 4, Day 8 and Day 12 in urinalysis parameters
timeFrame: Up to Day 12
measure: Number of subjects with abnormal clinical significant ECG evaluation
timeFrame: Up to Day 12
measure: Number of subjects with abnormal clinically significant findings of physical examination at Day 12.
timeFrame: Up to Day 12
measure: Change from baseline to Day 4, Day 8, Day 12 in systolic and diastolic blood pressure.
timeFrame: Up to Day 12
measure: Change from baseline to Day 4, Day 8 and Day 12 in pulse.
timeFrame: Up to Day 12
measure: Change from baseline to Day 4, Day 8 and Day 12 in oral body temperature.
timeFrame: Up to Day 12
Secondary outcomes:
measure: Change from baseline to Day 4, Day 8 and Day 12 in psoriatic infiltrate thickness (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography)
timeFrame: 12 days
measure: Change from baseline to Day 12 in disease severity
timeFrame: 12 days
Other outcomes:
Locations:
city: Schwerin
country: Germany
facility: Investigational Site
state: Mecklenburg-Vorpommern
city: Hamburg
country: Germany
facility: Investigational Site
Study officials:
affiliation: LEO Pharma
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00668057: BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
Official title: Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Male Erectile Dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 624
Sex: MALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
* Stable heterosexual relationship

Exclusion Criteria:

* Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
* Nitrate use
* Other exclusion criteria apply

Primary outcomes:
measure: Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15
timeFrame: 12 weeks
Secondary outcomes:
measure: Global Assessment Questionnaire
timeFrame: 12 weeks
measure: Erectile Function domain score of the International Index of Erectile Function
timeFrame: 12 weeks
measure: Safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06130657: Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure
Official title: Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure With Simultaneous Implant Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Sinus Lifting
Dental Implant
Keywords: Sinus lifting
Dental implant
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to present a guided lateral window sinus lift (GLSL) procedure with the aid of a fully digital workflow using surgical templates for window osteotomy preparation and implant placement.

Detailed description: In Group 1; The surgical procedure began with the adaptation of a prefabricated guide to the surgical site, ensuring firm stabilization. Implant positions were marked, and after the removal of the guide, a crestal incision was made. A mucoperiosteal flap was reflected, exposing the maxillary sinus and alveolar crest. The guide was readapted, marking implant positions, and a lateral window was formed using a bur or piezotome. Sinus membrane elevation was performed carefully. Implants were placed with graft material beneath the elevated membrane. In cases of bony plate preservation, the window was covered. In Group 2 (Lateral Maxillary Sinus Floor Elevation without a surgical guide), a crestal incision and mucoperiosteal flap exposed the sinus. A bony window was created, and careful elevation of the sinus floor followed. Implant osteotomies were completed, and graft material was packed into the sinus. A resorbable membrane was applied, and the flap was sutured. NanoboneÒ was used as the standard graft material in both groups.

Eligibility criteria: Inclusion Criteria:

* Healthy adult patients (over 18 years of age), without any systemic complication.
* Patients who need for dental implant in posterior maxilla with bone height below the maxillary sinus is \< 6 mm.
* Non smokers or patients who smoked less than 11 cig/day Will be included.

Exclusion Criteria:

* Uncontrolled systemic diseases which affect bone healing.
* Presence of any pathology in the site of operation.

Primary outcomes:
measure: Maxillary sinus volume
timeFrame: Preoperative, Immediate postoperative, 6 Months
Secondary outcomes:
measure: Bone Gain
timeFrame: Immediate postoperative, 6 Months
measure: Implant stability
timeFrame: Intra-operative, 6 Months
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Faculty of Dental Medicine
Study officials:
References: