louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02219542: Cytokines of Patients With Transversus Abdominis Plane Block After Laparoscopic Colonic Surgery
Official title: Cytokines of Patients After Laparoscopic Colonic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Colonic Surgery
Keywords: cytokine Transversus Abdominis Plane Block
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 80
Sex: ALL
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 investigators designed a study to determine whether with combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokines in patients undergoing Laparoscopic Colonic Surgery.

Detailed description: The investigators designed a study to determine whether combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokine in patients undergoing Laparoscopic Colonic Surgery.

Eligibility criteria: Inclusion Criteria:

* •Participants were deemed eligible if they were candidates for spinal anesthesia undergoing Laparoscopic Colonic Surgery

Exclusion Criteria:

* •Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24 (of the 30 possible points)

  * A history of neurological and psychiatric diseases including stroke, and psychosis
  * Severe visual or hearing impairment
  * Unwillingness to comply with the protocol or procedures

Primary outcomes:
measure: The change of cytokine level in plasma samples
timeFrame: just after anesthesia induction ; at the end of the surgery; 24h after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: The department of Anesthesiology
name: Hong Ma, M.D.,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00992342: A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03893787 In Healthy Adult Volunteers
Official title: A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Oral Doses Of PF-03893787 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate safety and toleration of multiple oral doses as well as the time course of PF-03893787 concentration in the blood following dosing by oral solution.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and females of non-childbearing potential between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

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

Primary outcomes:
measure: Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood (including creatine kinase) and urine safety tests and physical examination.
timeFrame: 22 days
Secondary outcomes:
measure: Pharmacokinetic parameters: Cmax, Tmax, AUCτ, t½, accumulation ratio,
timeFrame: 22 days
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 NCT06530342: Effect of Hamstring Muscle Length on Lunge Distance in Fencing Athletes
Official title: Determination of the Effect of Hamstring Muscle Length on Lunge Distance in Fencing Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletic Injuries
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Fencing Sword Branch Athletes

Brief summary: The aim of this study was to determine the effect of hamstring muscle length on lunge distance in fencing sword athletes.

Detailed description: The aim of this study was to determine the effect of hamstring muscle length on lunge distance in fencing sword athletes. A goniometer was used to assess hamstring muscle length and a tape measure was used to assess lunge distance in 20 athletes who agreed to participate in the study and signed the consent form. We believe that the results of our study will provide new perspectives on increasing the success of fencing sword athletes and reducing their injuries. SPSS 24.0 program will be used for statistical analysis. Pearson correlation test will be applied to evaluate the relationship between hamstring muscle length and lunge distance.

Eligibility criteria: Inclusion Criteria:

* Being an active licensed fencing athlete in the Anatolian Archery and Fencing Club
* Being an athlete in the sword branch.
* Being a volunteer to participate in the study
* Being between the ages of 18-30

Exclusion Criteria:

* Having done a strenuous exercise that would affect muscle groups the day before the measurements
* Having used alcohol and/or any medication the day before the measurements

Primary outcomes:
measure: Hamstring Muscle Length
timeFrame: at baseline
measure: Lunge Distance
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Anatolian Archery and Fencing Club
Study officials:
affiliation: Halic Üniversity
name: Duygu Sahin Altac, PT, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gajdosik R, Lusin G. Hamstring muscle tightness. Reliability of an active-knee-extension test. Phys Ther. 1983 Jul;63(7):1085-90. doi: 10.1093/ptj/63.7.1085.
Clinical trial NCT01056042: Efficacy of Injectable Contraceptive and Oral Contraceptive Administered After Surgical Treatment of Endometriosis With Pain
Official title: Postoperative Intramuscular Depot Medroxyprogesterone Acetate Versus Continuous Oral Contraceptive for Pelvic Pain Associated With Endometriosis : Randomized Comparative Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometriosis
Keywords: pelvic pain
postoperative
medical therapy
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 112
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: Patients with endometriosis-associated pain have conservative surgery performed to remove all visible lesions. Then, patients are randomized into two groups. In the first group patients have depot medroxyprogesterone acetate injections every 3 months for a total of 6 months.In the second group patients have oral contraceptive combined pills everyday for 6 months. Patients are followed up on recurrence of pain for 1 year after medication.


Eligibility criteria: Inclusion Criteria:

* Premenopausal women from 18 to 45 years of age with endometriosis-associated pain for at least 6 months who had conservative surgery performed.

Exclusion Criteria:

* Medical therapies for endometriosis other than NSAID within previous 6 months
* Contraindication to the drugs
* Wish to conceive
* Request for extirpative surgery
* Other pelvic pathology ( adenomyosis, chronic PID, submucous myoma uteri )

Primary outcomes:
measure: Patients' satisfaction with the treatment
timeFrame: 1 year and 6 months
Secondary outcomes:
measure: pain reduction and adverse side effects
timeFrame: 1 year and 6 months
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
state: Songkla
Study officials:
affiliation: Faculty of Medicine, Prince of Songkla University
name: Sopon Cheewadhanaraks, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vercellini P, Frontino G, De Giorgi O, Pietropaolo G, Pasin R, Crosignani PG. Continuous use of an oral contraceptive for endometriosis-associated recurrent dysmenorrhea that does not respond to a cyclic pill regimen. Fertil Steril. 2003 Sep;80(3):560-3. doi: 10.1016/s0015-0282(03)00794-5.
Clinical trial NCT03975842: Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps
Official title: Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
Keywords: otitis media with effusion (OME)
prevalence
risk factor
endoscopic nasal examination
otoscopic examination
pure-tone audiometry
tympanometry
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-06-05
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic rhinosinusitis with nasal polyposis (CRSwNP)

Brief summary: The relationship between otitis media with effusion (OME) and chronic rhinosinusitis with nasal polyposis (CRSwNP) remains unclear. A cross-sectional study of 80 consecutively presenting patients who were diagnosed with CRSwNP was conducted. The aim was to ascertain the prevalence of OME in CRSwNP patients, to determine whether the severity of CRSwNP affected OME, and to identify risk factors for OME in CRSwNP patients.


Eligibility criteria: Inclusion Criteria:

* Patients over 15 years of age
* Presence of chronic rhinosinusitis with nasal polyposis (CRSwNP) previously diagnosed or diagnosed at study's onset by endoscopic nasal examination

Exclusion Criteria:

* Presence of a mucopurulent discharge or granuloma during endoscopic nasal examination

Primary outcomes:
measure: The prevalence of OME in CRSwNP patients.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04581642: Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report
Official title: Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report: An Exploratory, Prospective, Unblinded, Single-center Study- The MoNOLog Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Opioid Use
Dementia
Unconscious
Ventilator Lung
Lead sponsor: Medasense Biometrics Ltd
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a clinical syndrome due to disease of a progressive nature, which leads to disturbances in multiple higher cortical functions, including memory, thinking, orientation, comprehension, calculation, learning capacity, language and judgment;

1. Older adults with advanced dementia;
2. Critically ill/unconscious patients;
3. Patients at the end of life stage.
4. Ventilated patients.

Brief summary: In this study we aimed to investigate the performance and effectiveness of NOL and/or NOLedge as a tool for pain assessment in geriatric and critical ill non communicating patients.

Our hypothesis was that NOL and the NOLedge may have good correlation with the health-care professional assessment PAINAD, BPS values, even with the use of the drugs affecting autonomic nervous system.


Eligibility criteria: Inclusion Criteria:

* Male and female, Age \> 18 years old.
* Spontaneously breathing or mechanically ventilated
* Any patient who is unable to express his/her own level of personal pain by using visual scales according to the hospital standard
* Written informed consent provided by the participant (if they have capacity) or guardian (if they do not have capacity) or a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant.

Exclusion Criteria:

* A patient whose staff or research team believes that his or her participation in the research will cause suffering to the patient.
* Unstable condition preventing planned routine procedures of care, and conditions precluding the use of PMD-200: absence of sinus cardiac rhythm.

Primary outcomes:
measure: Efficacy outcome
timeFrame: 5 months
measure: Efficacy outcome
timeFrame: 5 months
measure: Efficacy outcome
timeFrame: 5 months
measure: Efficacy outcome
timeFrame: 10 months
Secondary outcomes:
measure: Efficacy outcome
timeFrame: 10 months
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Dorot Netanya Gariatric Medical Center
Study officials:
affiliation: DOROT, Netanya Geriatric Medical Center
name: Adi Sasson, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05342142: Effects of 12-week Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals
Official title: Effects of 12-week Aerobic and Resistance Exercises on Alexithymia, Depression and Quality of Life in Geriatric Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Alexithymia
Quality of Life
Physical Inactivity
Keywords: Depression
Alexithymia
Quality of Life
Elderly
Exercise
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to investigate the effects of aerobic and resistance exercises on depression, alexithymia levels and quality of life of elderly individuals.

Detailed description: In this study, investigators hypothesized that aerobic and resistance exercises can increase the quality of life of elderly individuals by reducing their depression and alexithymia levels. The aim of this study is to investigate the effects of aerobic and resistance exercises on depression, alexithymia levels and quality of life of elderly individuals.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 65 and over who volunteered to participate in the study,
* Conscious and without communication problems,
* No orthopedic injury that prevents walking
* Those who are physically inactive according to the International Physical Activity Assessment Questionnaire
* Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
* Being eligible to participate in an exercise program after a cardiac examination (resting ECG and questioning of cardiac symptoms, advanced tests such as exercise ECG test if necessary) performed by the physician.

Exclusion Criteria:

* Having a history of neuromuscular disease
* Serious medical condition (eg advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
* Less than 1 year life expectancy
* Having an orthopedic injury that prevents walking
* Presence of advanced sensory deficit
* Having visual and hearing problems
* Not having sufficient communication skills (Mini Mental Test score below 24 points)
* Not having agreed to participate in the study
* Uncontrolled hypertension
* Not being found suitable for exercise in the examination performed by physicians and physiotherapists

Primary outcomes:
measure: Depression
timeFrame: 1 week
measure: Alexythimia
timeFrame: 1 week
measure: quality of life
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultan Abdülhamid Training and Research Hospital
state: Uskudar
Study officials:
affiliation: Sultan Abdülhamid Training And Research Hospital
name: Elif Yıldırım Ayaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00970242: Ambulatory Urodynamic Evaluation of Sacral Neuromodulation for Non-Obstructive Urinary Retention
Official title: Ambulatory Urodynamic Evaluation of Sacral Neuromodulation for Non-obstructive Urinary Retention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acontractile Bladder
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diminished or absent bladder contraction

Brief summary: Ambulatory Urodynamic measurement on patients with diminished or absent bladder contractility before and after trial with Sacral Neuromodulation therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with diminished or absent bladder contraction

Exclusion Criteria:

* Prior Neuromodulation therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MaastrichtUMC
Study officials:
affiliation: Maastricht University Medical Center
name: Sajjad Rahnama'i, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03496142: Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections
Official title: Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate biopsy approach
Transrectal prostate biopsy
Transperineal prostate biopsy
Iatrogenic infection
Prevention
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 340
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who will have prostate biopsy will be randomized 1:1 among transperineal or transrecal approach
Primary purpose: PREVENTION

Brief summary: Retrospective reports from literature have shown a lower rate of infections for transperineal versus transrectal approach for prostate biopsies in the setting of prostate cancer suspicion.

The aim of this study would be to compare in a prospective randomized trial the rate of infection with transperineal versus transrectal approach.

Detailed description: Retrospective reports from literature have shown a lower rate of infections for the transperineal versus transrectal approach for prostate biopsies in the setting of prostate cancer suspicion.

Post-biopsy infection is becoming a more and more challenging situation due to the increase of incidence and development of antibiotic resistant germs.

The aim of this study would be to compare in a prospective randomized trial the rate of infection with transperineal vs transrectal approach.

Patient presenting an indication of prostate biopsy (PSA elevation, suspicious lesion at digital rectal, suspicious lesion on MRI) would be randomized 1:1 among transrectal vs transperineal biopsies.

Post-biopsy infection would be monitored by systemic urine analysis at one, two and four weeks after procedure and in case of clinical symptoms.

Eligibility criteria: Inclusion Criteria:

* Indication of prostate biopsy

Exclusion Criteria:

* No indication of prostate biopsy
* Impossibility for prostate biopsy (e.g. major anal stenosis or history of anal amputation)
* Antibiotic treatment within three months before prostate biopsy

Primary outcomes:
measure: Rate of post-biopsy infection from Baseline to four weeks after prostate biopsy
timeFrame: Four weeks post-biopsy
Secondary outcomes:
measure: Presence of antibiotic resistant germ
timeFrame: One week, two weeks and four weeks post-biopsy
measure: Presence of complication post-biopsy : hematuria, urinary retention, rectoragy, any other complication
timeFrame: One week, two weeks and four weeks post-biopsy
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Alexandre INGELS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02951442: Identification of Markers (Klotho-FGF23 Axis) as Determinant in the Evolution of Arterial Stiffness During the First Year of Renal Transplant
Official title: Identification of Markers (Klotho-FGF23 Axis) as Determinant in the Evolution of Arterial Stiffness During the First Year of Renal Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplant
Keywords: Arterial stiffness
Klotho-FGF23
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective is to show that the contribution of Klotho by the renal graft is an independent determinant of the evolution of the recipient's central arterial stiffness during the first year of renal transplant. The contribution of Klotho by the graft will be estimated by: its circulating concentrations assay, its urinary excretion assay, and, indirectly, by the circulating concentrations of FGF23. The recipient's central arterial stiffness will be estimated by the measure of the carotid-femoral pulse wave velocity, noninvasive reference method for measuring aortic stiffness in human.


Eligibility criteria: Inclusion Criteria:

* Man or woman 18 to 70 years old
* Renal transplant
* Dead donor or alive donor
* Immunosuppression including a calcineurin inhibitor
* Written consent

Exclusion Criteria:

* MultipleTransplant
* Morbid Obesity (Body Mass Index (BMI)\> 40 kg/m2 sc)
* Cardiac Arrhythmia
* Lower limbs occlusive arterial disease
* Impossibility to understand the information form

Primary outcomes:
measure: Carotid-femoral pulse wave velocity
timeFrame: 12 months
Secondary outcomes:
measure: Sectional carotid stiffness
timeFrame: 12 months
measure: Carotid intima-media thickness
timeFrame: 12 months
measure: Endothelial function
timeFrame: 12 months
measure: Arterial calcification
timeFrame: 12 months
measure: Pulsed central veinous pressure
timeFrame: 12 months
measure: Klotho concentration
timeFrame: 1 day
measure: FGF23 concentration
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: AH-HP Hôpital Necker enfants malades
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hopital Foch
name: Michel Delahousse, MD
role: PRINCIPAL_INVESTIGATOR
References: