louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02201511: A Healthy Volunteer Trial to Gain Information About the Blood Concentrations of PF-06412562 After Oral Administration of a Modified Release Formulation in Fasted and Fed Conditions
Official title: A Phase 1, Open-label Study In Healthy Subjects To Investigate the Pharmacokinetics Of Pf-06412562 Following Single Oral Administration Of Modified Release Formulation In Fasted And Fed States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: relative bioavailbility
food effect
pharmacokinetics
ALTERATION OF COGNITIVE FUNCTIONS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-28
Enrollment: 12
Sex: ALL
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 study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Effect of food on absorption of PF-06412562 from the modified release formulation will also be investigated in this study.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; 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.
* Subjects who have attempted suicide in the past.
* Subjects who have an unexplained history of sudden death in their family

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0-2 days
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0-2 days
measure: Time after dose and before the first plasma concentration (Tlag)
timeFrame: 0-2
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
timeFrame: 0- 2 days
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: 0-2 days
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0-2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03036111: Effect of Topical Trimebutine on Pain After Hemorrhoidectomy
Official title: Effect of Trimebutine on Postoperative Pain After Milligan-Morgan Hemorrhoidectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Hemorrhoids
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trimebutine acts through smooth muscle relaxation. It is presumed that the topical application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure by relaxing the internal anal sphincter spasm.

Detailed description: A randomized trial will be carried out to investigate the effect of trimebutine on pain after Milligan-Morgan hemorrhoidectomy. Trimebutine relaxes the internal anal sphincter spasm which usually occurs after excisional hemorrhoidectomy.

Eligibility criteria: Inclusion Criteria:

* Patients of both genders aging between 18-70 years with grade III/VI internal hemorrhoids will be included

Exclusion Criteria:

* Patients with grade I/II internal hemorrhoids or external hemorrhoids.
* Patients with associated anorectal pathology such as anal fissure, anal fistula, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.\\
* Patients with recurrent hemorrhoids after previous surgery.

Primary outcomes:
measure: Pain assessment assessed using visual analogue score from 0-10
timeFrame: Pain will be assessed at 12 hours after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01946711: Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi
Official title: A Pilot Study to Investigate the Efficacy and Safety of Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis (CRS) With Polyposis Nasi in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rhinosinusitis
Chronic Polyposis
Keywords: CRS
polyposis
Lead sponsor: Pari Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2013-09-20
Enrollment: 14
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 study should create data for the selection of a clinically relevant primary endpoint to assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the therapy of chronic rhinosinusitis (CRS) with polyposis nasi in adult patients. Ideally, the selected parameter should allow a correlation between an objective methodology and the clinical outcome of the study patients.


Eligibility criteria: Inclusion Criteria:

* Patient with confirmed diagnosis of chronic rhinosinusitis (CRS) with polyposis nasi grade I-III
* Patient with a PNIF of \> 7 l/min separated for left and right side of the nose
* Patient's written informed consent
* Male or female,\>= 18 years of age
* Patient is able to undergo nasal therapy without restrictions
* Capable of understanding the purpose and risk of the clinical trial
* Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration
* Patient has completed correctly the diary during the Wash-in Phase

Exclusion Criteria:

* Patients with cystic fibrosis
* Patients with polyposis nasi grade IV
* Patients with prior sinonasal surgery (exemption: polypectomy)
* Patients with primary ciliaritis
* Pregnant or breastfeeding women
* Patients with suspected active upper airway infection
* Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
* Drug or alcohol abuse
* End-stage malignancies
* Known hypersensitivity to Budesonide
* Patients with oral steroid therapy within the last 4 weeks
* Patients with frequent epistaxis (\> 2 per month)

Primary outcomes:
measure: Change of Inflammation of the Nasal Mucosa and Paranasal Sinus
timeFrame: Change from Baseline to Week 8
Secondary outcomes:
measure: Safety Assessment
timeFrame: up to 26 weeks
Other outcomes:
measure: Health-specific Quality of Life
timeFrame: 24 weeks
measure: Nasal Obstruction
timeFrame: 4 weeks / 8 weeks
Locations:
city: Göttingen
country: Germany
facility: University Göttingen
city: Mainz
country: Germany
facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
city: Munich
country: Germany
facility: University LMU Munich
city: Rosenheim
country: Germany
facility: HNO-Zentrum Mangfall-Inn
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Sven Becker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02546011: The Monica Fetal Heart Monitor
Official title: The Monica External Fetal Heart Rate Monitor Compared to the Standard Fetal Heart Rate Monitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Heart Tracing
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 36
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The potential participants will be on the antepartum service so we will be providing them with antepartum and obstetrical care clinically.

Brief summary: The goal of this study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.

Detailed description: If a patient is admitted to the antepartum service and is between 24 - 28 weeks gestation, the investigators will approach the patient and inform her about the study. If the patient agrees to the study then the baby's heart tracings and contraction pattern will start to be monitored using the traditional device. If the patient would be receiving continuous fetal heart rate monitoring, then after at least 2 hours of monitoring with the traditional device, the traditional device would be replaced with the Monica device for 2 hours. After the Monica device is used for 2 hours, then the traditional device would be used once again. The entire length of the patient's participation in the study should be nor more than 6 hours.

The data collection sheet shows all data elements to be collected from the medical record. In addition it is standard of care that the monitoring strips become part of the medical records and these will also be reviewed as per the data collection sheet. Time it should take to review a patients medical record will be about 1 hour.

Total time of patient's involvement will be 7 hours.

Eligibility criteria: Inclusion Criteria:

* Pregnant patients between 24 and 28 weeks admitted to the antepartum service

Exclusion Criteria:

* Patients with a non viable pregnancy
* Patients with multiple gestation
* Clinically Unstable patients
* Non English speaking patients

Primary outcomes:
measure: To compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device
timeFrame: How long can hetal heart tracings be capture continuously
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Gary Fruhman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03454711: Functional Magnetic Resonance Imaging (fMRI) Exploration of Neurocognitive Processes Involved in Food Addiction (FA) in Obese Patients: Towards New Phenotypic Markers for an Optimized Care Pathway
Official title: Functional Magnetic Resonance Imaging (fMRI) Exploration of Neurocognitive Processes Involved in Food Addiction (FA) in Obese Patients: Towards New Phenotypic Markers for an Optimized Care Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Keywords: Obesity
Food addictions
Functional magnetic resonance imaging (fMRI)
Metabolomics
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut NuMeCan, INRAE 1341
First posted: 2018-03-06
Enrollment: 47
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task context based on food choice making

Detailed description: Obesity is a worldwide epidemic associated with many complications. The treatment of obesity is a failure if it does not take into account eating disorders. Among them, food addictions seem to be frequent among obese patients. Clinical diagnosis and therapeutic approaches depend on presence of these FA. Moreover, eating disorders are associated with visible brain abnormalities in fMRI but the cerebral fMRI phenotype of FA is not known.

Eligibility criteria: Inclusion Criteria:

* female
* right-handed
* grade 1 and 2 obesity
* aged between 20 and 50
* no other addictions including smoking
* no contraindications to fMRI
* affiliated to French Social Security
* having given a written informed consent

Exclusion Criteria:

* abdominal circumference + upper limbs along the body \> 200cm
* addiction to alcohol or other psychoactive substances
* daily smoker
* sleep Apnea Syndrome paired
* psychotic psychiatric disorders
* history of bariatric surgery
* medical care in the nutrition unit
* inability to comprehend or complete questionnaires
* pregnant or breastfeeding woman
* persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.

Primary outcomes:
measure: Significant change in brain activity of the prefrontal cortex (area involved in the inhibitory control of food intake) measured by modification of BOLD (Blood-Oxygen-Level-Dependent) signal in fMRI during a cognitive task based on food choice making
timeFrame: Month 2
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Institut NuMeCan, INRA 1341, INSERM 1241, Université de Rennes 1
name: David Val-Laillet, MSc, PhD, HDR
role: STUDY_DIRECTOR
References:
Clinical trial NCT01212211: Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?
Official title: Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyponatremia
Keywords: Hyponatremia; Sodium level
Falls
Gait
elderly
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2010-09-30
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Mild hyponatremia is the commonest electrolyte imbalance in the older population. Recently, association between hyponatremia and bone fractures in the ambulatory elderly has been shown.

Mild chronic hyponatremia is causing falls and lead to hospitalisation because of attention deficit.

Symptoms related to hyponatremia can be very subtle and difficult to detect clinically. Twenty elderly patients, retirement homes residents, with serum sodium \< 135mEq/L will be included. They will be randomised. The physician will review the drug treatment of ten patients in coordination with the opinion of pharmacologists. Drug treatment for ten other patients wil remained unchanged during the three months of inclusion.

Useful elements of the medical records of patients randomized to the experimental arm will be forwarded to the Pharmacovigilance Regional Center for opinion pharmacologist. The notice, subject to the attention of physician of retirement homes, give rise to a therapeutic approach towards the patient. It will be followed by weekly monitoring of serum sodium for 4 weeks to evaluate the impact of the intervention. Thus, the effectiveness of medical intervention will be evaluated by an objective biological criteria: serum sodium in the fourth week. Secondary endpoints will evaluate the duration of normalization of serum sodium and check the interest of correcting hyponatremia to improve postural capacities and eventually reduce the number of falls in the medium term (three months).


Eligibility criteria: Inclusion Criteria:

* Patient over 65 years Resident of dependent elderly
* Plasma sodium \<135 mmol / l less than a week, confirming earlier hyponatremia within a week to three month agreement given after patient information

Exclusion Criteria:

* Venous system does not allow sampling - Patient not taking medication-Dementia

Primary outcomes:
measure: Evaluate the benefit of a change of drug therapy following a review pharmacologist on the increase in serum sodium in elderly
timeFrame: Fourth week
Secondary outcomes:
measure: Normalization of serum sodium-Evaluate the impact on the deficit postural S4-Evaluate the impact on the occurrence of falls
timeFrame: three months
Other outcomes:
Locations:
city: Carentan
country: France
facility: Centre Hospitalier Carentan
Study officials:
affiliation: University Hospital, Caen
name: Blandine De la Gastine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03868111: Sufentanil as Adjuvant of Balanced Anesthesia
Official title: Comparison Between Sufentanil and Remifentanil as General Anesthetic Adjuvant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study was to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced general anesthesia.

Detailed description: The investigators hypothesized that sufentanil would reduce postoperative pain than remifentanil without prolonging recovery times in minor laparoscopic surgery when administered equivalent antinociceptive doses during surgery. Intraoperative opioid administration for equivalent nociception-antinociception balance could be achieved via surgical pleth index (SPI)-guided analgesia. This study was designed to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced anesthesia in patients undergoing laparoscopic cholecystectomy under SPI-guided opioid administration.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 19 and 65 years
* Patients with American Society of Anesthesiologists physical status I or II
* Patients scheduled for elective laparoscopic cholecystectomy under balanced general anesthesia for benign cholecystic diseases
* Patients obtaining written informed consent

Exclusion Criteria:

* Patients with asthma or hypertension
* Patients with an inability to express their pain accurately
* Patients with an inability to understand the pain scale
* Patients with chronic abdominal pain or chronic pain syndrome
* Patients who required to convert to laparotomy from laparoscopic surgery
* Patients who required to receive incidental lower abdominal procedures owing to adhesion, injury, or other incidental findings at the lower abdominal cavity
* Patients with a history of drug or alcohol abuse
* Pregnant women

Primary outcomes:
measure: Postoperative wound pain score
timeFrame: 10 minutes after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Kyoung-Ho Ryu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02434211: Interventional Research in Schools - Second Part
Official title: Interventional Research in Schools - Second Part
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
Collaborators: name: Laboratoire ACTé
name: Education Nationale
First posted: 2015-05-05
Enrollment: 291
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The main objective this project is the development of a measurement tool. This consists of construct and validate a questionnaire to conduct a quantitative assessment of knowledge and individual conceptions of cancer enrolled in CM1 and CM2 (9-11 years).

Detailed description: * exper judges by DELPHI method for content validity
* pre-testing for appearence validity
* testing for construct validity

Eligibility criteria: Inclusion Criteria:

* children enrolled in classes CM1 and CM2 of the departments of Loire, Essonne, Rhone and Ain

Exclusion Criteria:

Primary outcomes:
measure: Questionnaire validity
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02535611: Evaluation of Memantine Versus Placebo on Ischemic Stroke Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Stroke
Excitotoxicity
Memantine
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 47
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 researchers aim to investigate the effect of memantine on stroke outcome in a randomized double-blind placebo-controlled clinical trial.


Eligibility criteria: Inclusion Criteria:

* Presentation at first 24hrs of disease onset
* Confirmation of ischemic stroke in MCA territory by imaging.
* Accepted consent form

Exclusion Criteria:

* Allergy history to memantine
* Stage 4 -5 renal failure base on Acute Kidney Injury Network criteria
* Moderate to severe hepatic failure (Child-Pugh criteria, grade B and C)
* History of epilepsy
* History of dementia
* History of memantine use in recent 6 months
* Pregnancy or breastfeeding
* Severe drug adverse effects

Primary outcomes:
measure: Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS)
timeFrame: 7 days
measure: Investigation of Disability by Modified Rankin Scale (mRS)
timeFrame: 7 days
Secondary outcomes:
measure: Investigation of Neurological Deficit by National Institute of Health Scale Score (NIHSS)
timeFrame: 28 days
measure: Investigation of Disability by Modified Rankin Scale (mRS)
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
References: