louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03691480: Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Official title: Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pneumothorax, Spontaneous
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The management of spontaneous large pneumothorax is not consensual. The current management involves the establishment of a Fuhrman catheter and an outpatient monitoring in pneumology consultation. Another alternative is widespread: simple exsufflation. However, no study has looked at the direct prospective comparison of these 2 treatments.


Eligibility criteria: Inclusion Criteria:

* Episode of primary spontaneous pneumothorax wide according to the criteria

Exclusion Criteria:

-

Primary outcomes:
measure: Successful patient rates of ambulatory care
timeFrame: Day 6
Secondary outcomes:
Other outcomes:
Locations:
city: Lorient
country: France
facility: CH Lorient
city: Rennes
country: France
facility: CHU Rennes
city: Saint-Malo
country: France
facility: CH Saint-Malo
city: Sélestat
country: France
facility: CH Sélestat
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Rennes
name: Stéphane Jouneau
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06725680: Retrolaminar Block Versus Erector Spinae Plane Block as Opioid-Free Anesthesia for Enhanced Recovery After Posterior Lumbar Discectomy
Official title: Retrolaminar Block Versus Erector Spinae Plane Block as Opioid-Free Anesthesia for Enhanced Recovery After Posterior Lumbar Discectomy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retrolaminar Block
Erector Spinae Plane Block
Opioid-Free Anesthesia
Enhanced Recovery
Lumbar Discectomy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 90
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 aim of this study is to compare retrolaminar block and erector spine plane block as opioid-free anesthesia for enhanced recovery after posterior lumbar discectomy.

Detailed description: Lumbar discectomy is a common procedure for patients who experience leg and back pain due to disc problems. Effective pain management is crucial for timely discharge and successful rehabilitation.

Opioid-free anesthesia is a technique that avoids the use of opioids during surgery. Enhanced recovery after surgery (ERAS) pathways are helpful strategies for incorporating opioid-free pain management techniques into clinical practice.

Erector spine plane block (ESPB) and retrolaminar block (RLB) are considered to be compartment blocks or interfacial plane blocks. In these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Undergoing elective posterior lumbar discectomy under general anesthesia.

Exclusion Criteria:

* Body mass index (BMI) \>35 kg/m2.
* Patients with disturbed mental status.
* Allergies to the drugs used in the study.
* Local infection at the puncture site.
* Cardiac insufficiency.
* Renal insufficiency.
* Coagulopathy.
* Chronic opioid use.

Primary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Recovery time
timeFrame: Till first response to verbal command (Up to 1 hour)
measure: Time to discharge
timeFrame: Till the Aldrete score is ≥9 (Up to 3 hours)
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Length of hospital stay
timeFrame: Till discharge from hospital (Up to 1 week)
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT03003780: Mindful Steps: Promoting Physical Activity
Official title: Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Patients With Cardiopulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Heart Failure
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a developmental project with two phases. The first phase will adapt an existing web-based intervention to incorporate mind-body exercises to develop a multi-modal intervention to promote physical activity in patients with COPD and HF. The second phase will pilot test this new intervention in a longitudinal study (subjects randomized to intervention or usual care).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD OR clinical diagnosis of HF syndrome (New York Heart Association Class 1-3)
* Able to participate in an exercise program
* Have an active email account and access to a computer with internet connection

Exclusion Criteria:

* COPD or HF exacerbation in the previous month
* Inability to ambulate
* Clinical signs of unstable cardiovascular disease
* Hypoxemia during 6MWT
* Inability to collect at least 7 of 14 days of baseline step counts
* Current participation in a cardiac or pulmonary rehabilitation program.

Primary outcomes:
measure: Feasibility
timeFrame: 6 months
Secondary outcomes:
measure: Self-efficacy
timeFrame: baseline, months 3, 6, 9 and 12
measure: Physical activity
timeFrame: baseline, months 3,6,9, and 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: BIDMC
state: Massachusetts
Study officials:
References:
citation: Litrownik D, Gilliam EA, Wayne PM, Richardson CR, Kadri R, Rist PM, Moy ML, Yeh GY. Development of a Novel Intervention (Mindful Steps) to Promote Long-Term Walking Behavior in Chronic Cardiopulmonary Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 29;10(4):e27826. doi: 10.2196/27826.
Clinical trial NCT01667380: An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)
Official title: Non-interventional Study on the Use of Mircera in the Treatment of Chronic Renal Anemia in Patients With Chronic Kidney Disease Stages III-IV Not on Dialysis and in Patients on Stage V on Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-17
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis

Brief summary: This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Patients with chronic renal anemia with stage III-IV CKD not on dialysis and who are, in the opinion of the treating physician, not expected at baseline to require dialysis within 12 months
* Patients with chronic renal anemia with stage V CKD on dialysis
* No contraindication to ESA treatment

Exclusion Criteria:

* Uncontrolled hypertension
* Hypersensitivity to the active substance or any other of the excipients of Mircera and other ESAs

Primary outcomes:
measure: Dosage/schedule of Mircera treatment in clinical practice
timeFrame: approximately 3 years
Secondary outcomes:
measure: Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment
timeFrame: approximately 3 years
measure: Change in Hb levels
timeFrame: from baseline to Month 12
Other outcomes:
Locations:
city: Podgorica
country: Montenegro
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02013180: Zinc/PSA Ratio as a Novel Biomarker for Prostate Cancer Detection
Official title: Zinc/PSA Ratio as a Novel Biomarker for Prostate Cancer Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer Detection
Keywords: Prostate cancer, PSA, zinc, zinc/PSA
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2013-12-17
Enrollment: 480
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with LUTS(lower urinary tract symptomps) and elevated serum PSA levels/suspicious rectal examination who undergone transrectal ultrasonography guided prostate biopsy

Brief summary: Although Prostate Specific Antigen (PSA) is a useful marker for early detection of the prostate cancer, its specivity is not sufficient. Several PSA variations were defined in order to increase the specivity of the test, but they aren't much more effective than the PSA alone for detection of disease.

In older studies reported that, serum and prostatic tissue zinc levels decreased in prostat cancer disease.

In our study we aimed to establish the utility of serum zinc, PSA, free PSA/PSA (fPSA/tPSA), zinc/PSA, levels for early detection of the prostate cancer.


Eligibility criteria: Inclusion Criteria:

Patients with LUTS and elevated serum PSA levels and/or suspicious rectal examination

Exclusion Criteria:

usage of zinc included drugs, older prostatic operations, older prostatic radiotherapy, older prostatic biopsies, chronic rectal diseases (anal fissure, hemorrhoid, etc..), PIN(prostatic intraepithelial neoplasia) and ASAP(atypical small acinar proliferation) in pathologic evaluation.

Primary outcomes:
measure: Assesment of Serum Zinc/PSA Ratio in Patients With Prostate Cancer and Benign Prostatic Diseases
timeFrame: measurement of serum zinc and PSA levels are performed prior to transrectal prostat biopsy; pathologic evaluation of biopsy specimens are performed within 2-3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Training and Research Hospital-Depertmant of Urology
state: Bagcilar
Study officials:
References:
citation: Temiz MZ, Cakir OO, Aykan S, Kucuk SH, Tiryakioglu NO, Bilek G, Tunali NE, Kandirali E, Semercioz A. The use of serum zinc to prostate-specific antigen ratio as a biomarker in the prediction of prostate biopsy outcomes. Biomark Med. 2019 Feb;13(2):59-68. doi: 10.2217/bmm-2018-0260. Epub 2019 Jan 23.
Clinical trial NCT06871280: Assessment of Vertigo and Dizziness in Individuals Following COVID-19
Official title: Assessment of Vertigo and Dizziness in Individuals Following COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-11
Enrollment: 296
Sex: ALL
Minimum age (years): 20
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study included 296 patients aged 20-66 years who had recovered from COVID-19 and presented to the outpatient clinic

Brief summary: This cross-sectional study aimed to assess the prevalence of dizziness/vertigo in individuals following COVID-19 and to investigate potential risk factors associated with these symptoms. A total of 296 patients aged 20-66 years who had recovered from COVID-19 were evaluated at Istanbul Physical Medicine and Rehabilitation Training and Research Hospital between June 1, 2021, and December 31, 2021. Clinical and demographic data, including COVID-19 history, comorbidities, and symptom characteristics, were collected. Dizziness-related disability was assessed using the Dizziness Handicap Inventory (DHI), while balance performance was evaluated with the Berg Balance Scale (BBS).


Eligibility criteria: Inclusion Criteria:

* Individuals aged 20-66 years.
* History of confirmed COVID-19 infection.
* Ability to speak and understand Turkish.
* Willingness to provide verbal and written informed consent.

Exclusion Criteria:

* Pre-existing vertigo or balance disorders (e.g., benign paroxysmal positional vertigo, Ménière's disease, vestibular migraine, vestibular neuritis).
* Inner ear diseases or vestibular dysfunction.
* Neurological disorders affecting balance (e.g., multiple sclerosis, Parkinson's disease, history of stroke, epilepsy).
* Psychiatric conditions that could cause dizziness (e.g., anxiety, panic attacks, depression).
* History of head or neck trauma in the past six months.
* Moderate to severe visual impairment.
* Chronic alcohol or substance use.
* Use of ototoxic medications.
* Severe cardiovascular diseases (e.g., orthostatic hypotension, advanced heart failure, severe arrhythmias).
* Pregnant or breastfeeding women.
* Acute infection other than COVID-19 in the past three months.
* Severe COVID-19 requiring hospitalization

Primary outcomes:
measure: Dizziness Handicap Inventory
timeFrame: 0 day
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 0 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
References:
Clinical trial NCT01201980: An Epidemiological Study to Evaluate Standard Daily Practice in Managing Patients With Arterial Hypertension
Official title: An Epidemiological Study to Evaluate Standard Daily Practice in Managing Patients With Arterial Hypertension and to Evaluate Patients' Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: essential arterial hypertension
calcium antagonist
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Speciality care clinics

Brief summary: This study is aimed to evaluate response rate of the antihypertensive treatment with a calcium antagonist in real life practice, to evaluate patients' quality of life and to collect the following Serbia-specific epidemiology data on hypertension: demographic data, patents characteristics, and patients' management/treatment.


Eligibility criteria: Inclusion Criteria:

* Subject population with essential arterial hypertension currently receiving treatment with a calcium antagonist

Primary outcomes:
measure: To evaluate proportion of patients on antihypertensive pharmacological treatment reaching SBP goals according to the ESC 2007 guidelines (<140 mmHg*).
timeFrame: 24 weeks
Secondary outcomes:
measure: To evaluate proportion of patients on antihypertensive pharmacological treatment reaching DBP goals according to the ESC 2007 guidelines (<90 mmHg*).
timeFrame: 24 weeks
measure: To collect local epidemiological date on patients with hypertension (demographic data; hypertension management data: treatment, treatment changes and tolerability data).
timeFrame: 24 weeks
measure: To evaluate patients quality of life after 12 and 24 weeks by using patients quality of life questionnaire
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Research Site
city: Cacak
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Niska Banja
country: Serbia
facility: Research Site
city: Nis
country: Serbia
facility: Research Site
city: Pancevo
country: Serbia
facility: Research Site
city: Sabac
country: Serbia
facility: Research Site
city: Sremska Kamenica
country: Serbia
facility: Research Site
Study officials:
affiliation: Clinical Center of Serbia, Belgrade
name: prof. dr Zorana Vasiljevic
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05715489: Pectopexy Surgery Without Mesh
Official title: Evaluation of the Results of Laparoscopic Pectopexy Surgery Without Using Mesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-02-08
Enrollment: 38
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: it is aimed to examine the effect of laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse Measurement (POP-Q) and quality of life of the patient.

Detailed description: Every gynecological patient with prolapse is evaluated with POP-Q staging. The POP-Q staging to be performed before the laparoscopic pectopexy operation without mesh (performed by using non-melting sutures with natural tissue repair) performed on the patients will be compared with the POP-Q staging that will be performed 6 months after the operation. In addition, the quality of life of patients before and 6 months after the operation will be compared with the incontinence quality of life scale questionnaire of Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12).

Eligibility criteria: Inclusion Criteria:

* having pelvic organ prolapse greater than stage 2 according to POP-Q evaluation system
* being sexually active

Exclusion Criteria:

* Disease requiring chronic steroid use
* Asthma
* Having chronic obstructive pulmonary disease
* Having malignancy,
* Having metabolic and rheumatological diseases that impair tissue healing, such as scleroderma

Primary outcomes:
measure: Pre and post operative assessment of POP-Q measurements
timeFrame: 2 year
measure: Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Suleyman Salman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02406989: A Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety and PK in Healthy Volunteers
Lead sponsor: MingSight Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of MS-553 in healthy volunteers. Endpoints are safety, tolerability, and pharmacokinetics. Subjects are dosed for 14 days.


Eligibility criteria: Inclusion Criteria:

* In good general health with BMI 18 to 32 kg/m2. Females must be nonpregnant, nonlactating, postmenopausal at least 2 years or surgically sterilized at least 6 months prior

Exclusion Criteria:

* History of skin rash, migraine, or clinically significant ocular diseases, conditions predisposing to QT prolongation

Primary outcomes:
measure: Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 14 days
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 14 days
measure: Area under the Plasma Concentration versus Time Area under the Plasma Concentration versus Time Curve
timeFrame: 14 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
References:
Clinical trial NCT00820989: Inflammation and the Host Response to Injury (In Healthy Volunteers)
Official title: Inflammation and the Host Response to Injury (In Healthy Volunteers)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System
Keywords: Healthy Immune System
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2009-01-12
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The body's immune response to injury or infection is very complex.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether certain proteins, genetics, or heart rate variability change affects the body's response to endotoxin.

Detailed description: The body's immune response to injury or infection is very complex.Immune cell activity, the release of specific mediators(such as proteins, genetics(Deoxyribonucleic acid or DNA), the body's "instructions" for making proteins (Ribonucleic Acid or RNA) and heart rate variability (HRV,the intervals between heartbeats) may affect the body's clinical response to stress such as infection.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether any of the above (proteins,genetics,or HRV, etc.) correlate with or affect the body's response to endotoxin.This will enable the investigator to better understand the mechanisms involved in the immune response as well as potential therapeutic strategies to improve outcomes in patients.

Eligibility criteria: Inclusion Criteria:

* Good general health as demonstrated by medical history,physical exam, and laboratory tests within 6 weeks of study.
* Written informed consent prior to the performance of any study related procedure.

Exclusion Criteria:

* History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
* Recent history of alcohol or drug abuse
* Mental capacity limited to the extent that the subject cannot provide written informed consent or information regarding treatment-emergent adverse events and/or tolerance of study medication and/or study procedures
* Exposure to any experimental agent or procedure within 30 days of study
* Pregnancy or breast feeding
* Prior exposure to endotoxin in an experimental setting -

Primary outcomes:
measure: Physiological, Hematological, Immunological Responses
timeFrame: .5-24 hours after Endotoxin administration
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers-RWJMS
state: New Jersey
Study officials:
affiliation: Rutgers-RWJMS
name: Siobhan Corbett, MD
role: PRINCIPAL_INVESTIGATOR
References: