louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01186185: Fludrocortisone for Sudden Hearing Loss
Official title: Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Hearing Loss, Sensorineural
Keywords: sudden
sensorineural
hearing loss
fludrocortisone
mineralocorticoid
steroid
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The standard of care treatment of sudden hearing loss uses a type of steroid called glucocorticoid. Examples of glucocorticoids are prednisone, methylprednisolone and dexamethasone. Not everybody recovers hearing with glucocorticoid treatment. Fludrocortisone is a different type of steroid called mineralocorticoid. Unlike glucocorticoids, which work by reducing inflammation, mineralocorticoids work by changing salt and fluid balance. In animal studies, fludrocortisone is at least as effective as glucocorticoid in preserving hearing. Fludrocortisone is not approved for the treatment of sudden hearing loss. The purpose of this study is to test whether fludrocortisone can treat sudden hearing loss.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Idiopathic sudden sensorineural hearing loss within 3 months
* Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid

Exclusion Criteria:

* Other diagnosis for the sudden hearing loss
* Concurrent systemic use of another steroid
* Hypersensitivity to fludrocortisone
* Systemic fungal infection
* Hypertension requiring two or more medications
* Pitting edema
* Cardiomegaly
* Congestive heart failure
* Electrolyte abnormality
* Concurrent use of barbiturates, phenytoin, fosphenytoin, rifampin, or rifapentine

Primary outcomes:
measure: Hearing
timeFrame: At one month
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Anh Nguyen-Huynh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02145585: Robotic Pharmacological Anesthesia System for Elective Cardiac Surgery
Official title: Completely Automated Robotic Pharmacological Anesthesia System for Patients Undergoing Elective Cardiac Surgery: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Keywords: Cardiac surgery
Robotic pharmacological anesthesia
Anesthesia
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2014-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective cardiac surgery with extracorporeal circulation

Brief summary: Closed loop systems for anaesthesia have been shown to be more efficient than manual administration and than Target Control Infusion systems (TCI). So far, there is only one single-center study demonstrating that a system using simultaneously three closed loops for each component of anaesthesia (hypnosis, analgesia and muscle relaxation) is possible, safe and is more efficient than manual administration of anaesthetic drugs. Although the results of this study are very encouraging, they are limited by its sample of patients recruited for non-cardiac surgery only.

The hypothesis of the present trial is that cardiac anesthesia using a completely automated anesthesia delivery system, encompassing each components of anesthesia (hypnosis, analgesia and muscle relaxation) is feasible, safe and reliable.

Thus, the objective of the present trial is to test this pharmacologic anesthesia robot on patients scheduled for elective cardiac surgical procedures with extracorporeal circulation.

Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS).

A BIS target of 45 is aimed trough the surgery. Performance of propofol hypnosis will be determined clinically by recording the % of sedation time during which the actual BIS is within 10% of the target BIS (excellent control), within 11 -20% (good control), between 21-30% (fair control) and beyond 30% of target (inadequate control).


Eligibility criteria: Inclusion Criteria:

* Elective patients
* Patients scheduled to receive an extracorporeal circulation
* Patients aged 18 and older

Exclusion Criteria:

* Minor
* Unable to provide informed consent
* Comatose patients
* Patients with dementia
* Patient who underwent neurosurgery
* Pregnant women
* Patient with muscle disease
* Allergy to Propofol and/or remifentanil

Primary outcomes:
measure: Performance of closed-loop system for propofol administration defined as the efficacy to maintain Bispectral Index (BIS) as close to the target of 45 as possible.
timeFrame: at inclusion (day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU de Bordeaux - Hôpital Haut Lévêque
Study officials:
affiliation: University Hospital, Bordeaux
name: Cédrick ZAOUTER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03444285: Effects of Warm up in Athletes With Previous Hamstring Injury
Official title: Analysis on the Effects of Two Types of Warm up in Athletes With a Previous Hamstring Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Previous Hamstring Injury
Keywords: Thermotherapy
warm-up
extensibility
pain
athletes
Lead sponsor: University of Extremadura
Sponsor class: OTHER
Collaborators: name: Luis Espejo Antúnez
First posted: 2018-02-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups. One realize an static warm-up and the other a dynamic warm-up.
Primary purpose: PREVENTION

Brief summary: The objectives of this study is to determine the immediate and 10 minutes follow-up effects of a warm-up based on a continous run on a treadmill or the application of a hot-pack in athletes with previous hamstring injury. The investigators have as an hypothesis that the subjects, after one of this interventions show statistically significant improvements in the measurements of pain, flexibility, proprioception and postural control


Eligibility criteria: Inclusion Criteria:

* To be 18-27 years old
* To do sports as a minimum of 5 hours per week.
* To have done sport in the last 2 years
* Have a hamstring flexibility of ≤80º on Kendall test
* Diagnosed hamstring injury the last year

Exclusion Criteria:

* To take drugs that alter the motor o postural control
* To do a program of stretching of the hamstring
* To have lumbar pain
* Recent abdominal or spinal surgery intervention

Primary outcomes:
measure: Range of movement
timeFrame: Changes from baseline at immediately after and at 10 minutes after the intervention
measure: Pain
timeFrame: Changes from baseline at immediately after and at 10 minutes after the intervention
Secondary outcomes:
measure: Pressure pain threshold (PPT)
timeFrame: Changes from baseline at immediately after and at 10 minutes after the intervention
measure: Joint Position Sense
timeFrame: Changes from baseline at immediately after and at 10 minutes after the intervention
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Universidad de Extremadura
Study officials:
name: Javier Gutiérrez Coronado, Physioterapist
role: STUDY_DIRECTOR
References:
Clinical trial NCT06070285: Investigating Participation Patterns Among Recurrent Ovarian Cancer Patients
Official title: Delving Into the Patterns of Patient Engagement and Trends in Participation Within Recurrent Ovarian Cancer Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Recurrent Ovarian Cancer
Keywords: Recurrent Ovarian Cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with recurrent ovarian cancer who are actively considering enrolling in a clinical trial for said condition, but have not yet completed enrollment and randomization.

Brief summary: Clinical trials, with a particular focus on recurrent ovarian cancer, play a crucial role in assessing the safety and efficacy of novel treatments for this condition. These trials serve as essential tools to determine whether new medications outperform traditional therapies, providing substantial evidence to support their widespread adoption.

By actively participating in recurrent ovarian cancer observational study serves pivotal role in expanding the boundaries of medical knowledge and advancing the quality of care provided to those enduring the same condition.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Able to comprehend the investigational nature of the protocol and provide informed consent
* Diagnosis of recurrent ovarian cancer

Exclusion Criteria:

* No diagnosis of recurrent ovarian cancer confirmed
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Number of patients who decide to participate in a recurrent ovarian cancer clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in recurrent ovarian cancer clinical research to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Buechel M, Herzog TJ, Westin SN, Coleman RL, Monk BJ, Moore KN. Treatment of patients with recurrent epithelial ovarian cancer for whom platinum is still an option. Ann Oncol. 2019 May 1;30(5):721-732. doi: 10.1093/annonc/mdz104.
citation: Ozga M, Aghajanian C, Myers-Virtue S, McDonnell G, Jhanwar S, Hichenberg S, Sulimanoff I. A systematic review of ovarian cancer and fear of recurrence. Palliat Support Care. 2015 Dec;13(6):1771-80. doi: 10.1017/S1478951515000127. Epub 2015 Mar 2.
citation: Hilal Z, Schultheis B, Hartmann F, Dogan A, Cetin C, Krentel H, Schiermeier S, Tempfer CB. What Characterizes Long-term Survivors of Recurrent Ovarian Cancer? Case Report and Review of the Literature. Anticancer Res. 2016 Oct;36(10):5365-5371. doi: 10.21873/anticanres.11110.
Clinical trial NCT04286685: Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury
Official title: Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury : the TROPUTILE Score. A Non-interventional Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perioperative Complication
Myocardial Injury
Keywords: Non cardiac surgery
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 1600
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged of 50 years and more, with elective orthopedic surgery in Brest community-affiliated hospital

Brief summary: Myocardial injury after noncardiac surgery (MINS) is common, silent, and strongly associated with morbi-mortality.

There are some evidences in the littérature showing that troponin elevation pre and/or postoperatively and surgical Apgar score are strongly and independently associated with postoperative morbi-mortality.

In this cohort study of orthopedic surgery patients (\> 50years), the aim is to determine MINS incidence and to assess wich peri-operative factors are associated with the occurrence of MINS. The final objective is to create a score to better identified the patients with a MINS and a poor outcome.


Eligibility criteria: Inclusion Criteria:

* \> 50 years
* orthopedic surgery (hip, knee, spine)
* written consent

Exclusion Criteria:

* no troponin measurement prior surgery
* sepsis
* acute coronary syndrome
* pulmonary embolism
* refusing to participate
* guardianship

Primary outcomes:
measure: Postoperative MINS incidence
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Number of Participants with cardiac arrest
timeFrame: 3 months
measure: Number of Participants with an episode of acute pulmonary oedema
timeFrame: 3 months
measure: Number of Participants with coronary angioplasty
timeFrame: 3 months
measure: Number of Participants with myocardial infarction
timeFrame: 3 months
measure: Number of Participants with stroke
timeFrame: 3 months
measure: Number of Participants with transient stroke
timeFrame: 3 months
measure: Mortality rate
timeFrame: 3 months
measure: Revised Cardiac Risk Index for Pre-Operative Risk (Lee score)
timeFrame: Inclusion
measure: Metabolic Equivalent of Task (MET)
timeFrame: Inclusion
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHRU Brest
name: Olivier HUET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01777685: Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride After Oral Administration to Healthy Volunteers
Official title: Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Sulpiride
Therapeutic drug monitoring
Pharmacokinetics
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The present study was adopted to evaluate the pharmacokinetics of sulpiride after oral administration.

Detailed description: The present study was adopted to evaluate the pharmacokinetics of sulpiride after administration of single oral doses of 50 mg in an open-label, one-way study.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old and not more than 45 healthy male volunteers
* Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame
* Who had passed all the screening parameters
* Free of any drug exposure known to interfere with the pharmacokinetics or assay of sulpiride for at least 10 days prior to the study
* Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.

Exclusion Criteria:

* A clinically significant abnormal physical exam, medical history, or laboratory studies If they showed a sitting SBP of \>140 or \<100 mmHg, DBP \> 90 or \<60mm Hg, or a pulse rate of \> 95 or \< 50 beats/min at screening A history of serious intolerance, allergy, or sensitivity to fexofenadine The use of any prescription drug within the previous month or use of any over-the-counter medication (with the exception of acetaminophen) within the past 14 days A history of blood dyscrasias A history of alcohol or drug abuse within the past year Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study Unable to tolerate vein puncture and multiple blood samplings Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion Cannot follow instructions, in the opinion of the investigator.

Primary outcomes:
measure: •Assessment of the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, on Days 1, 2, and 3, using the marketed tablet as the reference. Pharmacokinetics of sulpiride
timeFrame: The pharmacokinetic analysis is done after blood sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhour
country: Egypt
facility: Pharmaceutics Department, Faculty of Pharmacy, Damanhour University
Study officials:
References:
citation: Helmy SA. Therapeutic drug monitoring and pharmacokinetic compartmental analysis of sulpiride double-peak absorption profile after oral administration to human volunteers. Biopharm Drug Dispos. 2013 Jul;34(5):288-301. doi: 10.1002/bdd.1843. Epub 2013 May 19.
Clinical trial NCT04482985: Meclizine Plasma Levels in Responders and Non-responders
Official title: Meclizine Plasma Levels in Responders and Non-responders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Seasickness
Meclizine
Keywords: Seasickness
Plasma Levels
Meclizine
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Motion sickness is a debilitating condition that can effect many crew members. Meclizine has long been known as an effective anti motion sickness drug. The response to the drug is variable - some are responders, while others are resistant to the drug. The aim of the present study is to examine whether there is a correlation between meclizine plasma levels and clinical response.


Eligibility criteria: Inclusion Criteria:

* Seasickness questioner (WIKER) score of 7.
* Subjective functioning at 1 meter sea voyage - 5/10 and lower.
* Subjects who were prescribed 25mg of meclizine.
* Subjects who did not take any other drugs 48 prior to their participation in the study.

Exclusion Criteria:

* Known hearing loss or any vestibular impairment
* Vertigo complains
* Any ear infection
* Use of Scopolamine based anti-seasickness drugs.
* Use of meclizine 50mg.

Primary outcomes:
measure: Meclizine plasma levels
timeFrame: 2 hours after meclizine administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wang Z, Qian S, Zhang Q, Chow MS. Quantification of meclizine in human plasma by high performance liquid chromatography-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Jan 1;879(1):95-9. doi: 10.1016/j.jchromb.2010.11.022. Epub 2010 Dec 1.
Clinical trial NCT07006285: T2 Biomarkers Predictive Value in Occupational Asthma After Cessation of Exposure.
Official title: T2 Biomarkers Predictive Value in Occupational Asthma After Cessation of Exposure.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma
Occupational Asthma
Occupational Diseases
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Occupational exposure is known to cause 15% of asthma cases. The main treatment for occupational asthma is to stop exposure if possible. Although, remission of occupational asthma only occurs in only 30 % of patients after cessation of exposure. There is currently no way of predicting which patients will go into remission after cessation of exposure.

In non-occupational asthma, the inflammatory biomarker T2 has allowed the entry into personalized medicine and can predict future exacerbations.

The investigators hypothesize that T2 biomarkers could be predictive markers for remission in occupational asthma after exposure cessation.

The investigators intend to carry out a follow-up study at the University Hospital of Strasbourg to perform the non-specific bronchial hyperresponsiveness test to assess remission in patients diagnosed with occupational asthma and to compare baseline T2 biomarkers in remission and non remission patients.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Diagnosis of occupational asthma by specific inhalation challenge
* Exposure to sensitizing agent avoided or reduced
* Able to understand the aims and risks of the research and to give free and informed consent
* For women of childbearing age: effective contraception in progress.
* Benefiting from social security coverage

Exclusion Criteria:

* Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject)
* Subject under court protection
* Subject under guardianship or curatorship
* Pregnant or breast-feeding patient

Primary outcomes:
measure: Remission of occupational asthma
timeFrame: Day 1
measure: Comparison of TH2-type inflammation levels
timeFrame: Day 1
Secondary outcomes:
measure: Remission of occupational rhinitis
timeFrame: Day 1
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
Study officials:
References:
Clinical trial NCT00218985: Exercise-training Before Coronary Artery Bypass Graft (CABG)
Official title: Exercise-training Before Coronary Artery Bypass Graft (CABG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina
Coronary Artery Disease
Keywords: Aerobic capacity
Exercise training
CABG
Endothelial function
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is to evaluate the effect of exercise training upon endothelial function in the mammary artery of patients who are scheduled for CABG, as well as study the functional properties of single cells isolated from a small biopsy of the left ventricle obtained during surgery.


Eligibility criteria: Inclusion Criteria:

* Scheduled for CABG both with and without heart failure

Exclusion Criteria:

* Unstable angina
* Unable to walk on a treadmill (except those with heart failure who only will serve as a reference group)
* Participation in another study

Primary outcomes:
measure: Cardiovascular function and quality of life
timeFrame: Before and up to 1 year after intervention
Secondary outcomes:
measure: Structure and function of cardiomyocytes
timeFrame: After the intervention period
measure: Cardiomyocyte structure and function
timeFrame: after the intervention period
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisloff, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smenes BT, Baekkerud FH, Slagsvold KH, Hassel E, Wohlwend M, Pinho M, Hoydal M, Wisloff U, Rognmo O, Wahba A. Acute exercise is not cardioprotective and may induce apoptotic signalling in heart surgery: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2018 Jul 1;27(1):95-101. doi: 10.1093/icvts/ivx439.