louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03751605: Indirect Measurement of Respiratory Quotient in Unipulmonary Ventilation.
Official title: Validation of the Respiratory Quotient Measurement Measured Indirectly in Unipulmonary Ventilation (UNIQ Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Quotient Measurement
Keywords: unipulmonary ventilation, complications, respiratory quotient.
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Age\>18 years old
* Adults admitted to the operating room for thoracic surgery requiring unipulmonary ventilation

Exclusion Criteria:

* Cardiac surgery
* Laparoscopy
* Preoperative oxygen therapy

Brief summary: The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2) which is a reflection of human energy metabolism and therefore of anaerobiosis. A study has been conducted in our department to demonstrate the ability of the indirectly measured respiratory quotient (RQ) from the inspired and exhaled breath analysis of the anesthetic respirator to predict the onset of anaerobic metabolism and postoperative complications in the operating room.

Unipulmonary ventilation is the rule in thoracic surgery: it improves surgical exposure and protects the operated lung.

However, no study has examined the impact of these mechanisms on the indirect measurement of RQ in unipulmonary ventilation. The main objective of our work is to validate indirect RQ measurement during unipulmonary ventilation. The secondary objective was to assess the predictability of postoperative complications of indirect QR.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years old
* Adults admitted to the operating room for thoracic surgery requiring unipulmonary ventilation

Exclusion Criteria:

* Cardiac surgery
* Laparoscopy
* Preoperative oxygen therapy

Primary outcomes:
measure: Indirect respiratory quotient
timeFrame: during surgery
Secondary outcomes:
measure: occurrence of at least one post-operative complication
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT06602505: Comparative Analysis of Incidence of Newly Developed Postoperative Low Back Pain with Field Block Versus Without Field-block Before Spinal Anaesthesia for Patients Undergoing Caesarean Sections
Official title: Comparative Analysis of Incidence of Newly Developed Postoperative Low Back Pain with Field Block Versus Without Field-block Before Spinal Anaesthesia for Patients Undergoing Caesarean Sections.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caesarean Section
Keywords: Cesarean Section
Back Pain
Anesthesia, Local
Anesthesia, Spinal
Lidocaine
Lead sponsor: Tata Main Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aimed to evaluate the effectiveness of field block in preventing postoperative low back pain (PDPB) in patients undergoing Cesarean Sections.

Detailed description: The purpose of this study was to evaluate the effectiveness of field block with lidocaine 2% (5 ml) administered with a 24G hypodermic needle before spinal anesthesia for patients undergoing LSCS, in preventing the development of postoperative low back pain (PDPB). The study aimed to determine if using a field block would decrease the incidence of PDPB compared to patients who received only spinal anesthesia.

Eligibility criteria: Inclusion Criteria: All patients undergoing LSCS under spinal anesthesia, ASA Grade 2 and Grade 2E and willing to participate in the trial

Exclusion Criteria: Spine pathology/instability and coagulopathy, ASA Grade 3 and above, Pre-exiting low back pain, Morbid Obesity (BMI \&gt; 35), Patients needing more than 1 attempt for administration of spinal anaesthesia, Patients utilizing labour analgesia, Local infection or inflammation at the site of spinal anesthesia/field block, Unwilling to participate

-

Primary outcomes:
measure: Incidence of postoperative back pain
timeFrame: 90 days
Secondary outcomes:
measure: Birth weight of the child
timeFrame: 1 day
measure: Period of gestation (weeks)
timeFrame: Weeks between conception and birth when a baby through Caesarean Section
measure: Gravida
timeFrame: 1 day
Other outcomes:
Locations:
city: Jamshedpur
country: India
facility: Tata Main Hospital
state: Jharkhand
Study officials:
References:
Clinical trial NCT03929705: Assessing the Ability of the T-SPOT®.TB Test
Official title: Assessing the Ability of the T-SPOT®.TB Test to Identify Those at Risk of Active Mycobacterium Tuberculosis Infection Using the Normalized TB Specific Lymphocyte Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis (TB)
Keywords: TB
Lead sponsor: Oxford Immunotec
Sponsor class: INDUSTRY
First posted: 2019-04-29
Enrollment: 676
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: Male and Female 18 years of age and older.

Brief summary: The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response in identifying patients with active TB disease. The secondary exploratory objective is to demonstrate that active TB cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based IGRA.

Detailed description: The target number of subjects is 100 active TB and 100 active TB excluded . This study will enroll up to 680 subjects (based on previous enrolment rates of approximately 300-350 subjects enrolled for 50 active TB and 50 active TB excluded).

Study Duration: 6 months

All subjects enrolled in this study will be men or women, aged 18 years or older.

Eligibility criteria: Inclusion Criteria: Cohort 1a and 1b

* • Must be at least 18 years of age

  * Must be able to provide informed consent
  * Must be able to provide a minimum of 10 mL of whole blood at each visit (16mL for immunocompromised i.e. HIV+)
  * Must be T-SPOT.TB positive
  * First visit suspect TB subjects with no prior history of TB diagnosis Inclusion Criteria: Cohort 2a and 2b
  * Must be at least 18 years of age
  * Must be able to provide informed consent
  * Must be able to provide a minimum of 10 mL of whole blood at each visit (16mL for immunocompromised i.e. HIV+)
  * Must be T-SPOT.TB positive
  * No prior history of TB diagnosis

Exclusion Criteria: Cohort 1a and 1b

* • Negative in the T-SPOT.TB test

  * Previous or pre-existing confirmed TB diagnosis
  * On anti-TB treatment for more than 1 week\*
  * Not meeting inclusion criteria Exclusion Criteria: Cohort 2a and 2b
  * Negative T-SPOT.TB test
  * Previous or pre-existing confirmed TB diagnosis
  * On anti-TB treatment
  * Symptoms of active TB
  * Not meeting inclusion criteria

Primary outcomes:
measure: T-Spot
timeFrame: 6 month study
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town
Study officials:
affiliation: University of Cape Town
name: Keertan Dheda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05929105: AI-assisted Preoperative Planning Technology for THA for DDH
Official title: Short-term Outcome of Artificial Intelligence-assisted Preoperative Three-dimensional Planning of Total Hip Arthroplasty for Developmental Dysplasia of the Hip Compared With Traditional Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with DDH who underwent unilateral primary THA between January 2020 and July 2022 in the orthopaedic department.

Brief summary: In this study, the investigators retrospectively collected DDH case data of THA assisted by AI 3D planning and THA assisted by traditional planning. The compliance between preoperative planning and the type of prosthesis used in the operation, the position of the acetabular prosthesis, the correction of LLD and the postoperative joint function score were analysed to evaluate the short-term effect of AI combined with preoperative 3D planning in THA for DDH.


Eligibility criteria: Inclusion Criteria:

* DDH was diagnosed by clinical signs and imaging examination, and a primary THA was planned;
* the patient had persistent unilateral hip pain, which seriously affected their quality of life;
* the standard posterolateral approach was used;
* the contralateral hip was normal or had received THA;
* the proximal femoral Dorr classification was type A or B;
* The acetabular classification was Crowe type Ⅰ, Ⅱ, Ⅲ or IV;
* all patients were treated with the bioartificial hip joint PINNACLE® cup or SUMMIT® stem, developed by Johnson \& Johnson Biological.

Exclusion Criteria:

* preoperative and postoperative imaging examinations did not meet the evaluation criteria (non-standard double-hip anteroposterior film, acetabular angle and LL length could not be accurately measured);
* severe osteoporosis, tumour or metabolic disease around the affected hip joint;
* spinal deformity by other causes or a history of lumbar internal fixation;
* external deformity of the affected hip joint in the lower extremity;
* neuromuscular insufficiency (with hip abduction weakness and poliomyelitis);
* severe disease with intolerance to surgery.

Primary outcomes:
measure: Type of acetabular cup and femoral stem
timeFrame: 31 months
measure: Difference in the length of lower limbs before and after surgery
timeFrame: 31 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
References:
Clinical trial NCT05943405: The Disease Severity In Patients With Psoriasis
Official title: The Disease Severity In Patients With Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
Psoriasis Area and Severity Index
Gamma-Glutamyl Transferase
CRP
Apolipoprotein B
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Psoriasis Patients

Brief summary: This observational study aims to evaluate new markers to predict disease activity in psoriasis. The main question is SGOT, SGPT, GGT, hs-CRP, and apo B related to disease severity in psoriasis.

Detailed description: Psoriasis patients who had signed an informed consent were assessed for PASI scores and 5 cc of blood was drawn for GGT, hs-CRP, and apo B examinations. A PASI score is a tool used to measure the severity and extent of psoriasis. PASI is an acronym for Psoriasis Area and Severity Index.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Psoriasis

Exclusion Criteria:

* Heart Failure
* Diabetes Mellitus
* Kidney Disease

Primary outcomes:
measure: Gamma-Glutamyl Transferase
timeFrame: only in admission
measure: Apolipoprotein B
timeFrame: only in admission
measure: High-sensitivity c-reactive protein
timeFrame: only in admission
measure: PASI
timeFrame: only in admission
Secondary outcomes:
Other outcomes:
Locations:
city: Sukoharjo
country: Indonesia
facility: Universitas Sebelas Maret Hospital
state: Central Java
Study officials:
References:
citation: Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available.
citation: Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021.
Clinical trial NCT05686005: Tranexamic Acid in Functional Endoscopic Sinus Surgery
Official title: The Efficacy of Oral Versus Intravenous Tranexamic Acid in Functional Endoscopic Sinus Surgery. A Prospective, Randomized, Double-blind Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare the effect of oral tranexamic acid vs. intravenous in decreasing bleeding and improving the field during FESS.

Detailed description: The use of tranexamic acid during Intraoperative bleeding in functional endoscopic sinus surgery (FESS) improves the outcome. Bleeding is one of the most devastating complications during fess. Tranexamic acid is used in open heart surgery to improve the surgical field.

Using oral vs. intravenous forms of the drug will add to our knowledge and improve outcomes.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists grade I or II.
* Sex: Both sexes.
* Age between 18 and 40 years.
* Patients scheduled for FESS under general anesthesia.

Exclusion Criteria:

* Declining to give written informed consent.
* History of allergy to the medications used in the study.
* History of venous or arterial thrombosis.
* history of cardiovascular diseases including AF, IHD, or hypertension.
* History of chest problems including pulmonary embolism, bronchial asthma and COPD.
* History of cerebrovascular stroke.
* History of drug or alcohol abuse.
* Taking opioids or sedative medications.
* Hepatic or renal failure.
* Bleeding disorders, antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).

Primary outcomes:
measure: Intraoperative field bleeding
timeFrame: At 30 minutes after surgery start
Secondary outcomes:
measure: Incidence of the common adverse effects
timeFrame: At 24 hours
measure: Post operative D-dimer
timeFrame: At 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine, Ain Shams University
Study officials:
References:
Clinical trial NCT03806205: Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain
Official title: Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: To Investigate the Effect of Diclofenac on Pain Control of Knee Osteoarthritis and the Relationship Between Pain Relief and Medicine Adherence
Keywords: Knee osteoarthritis pain; Adherence; Diclofenac; Follow up
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate the effect of dichloride on pain control of knee osteoarthritis and the relationship between pain relief and medicine adherence. To evaluate the pain relief rate of patients with different initial pain.


Eligibility criteria: Inclusion Criteria:

* According to the OA diagnostic criteria of knee joint, the side with higher WOMAC score is defined as observing knee joint for patients with both knees conforming to OA diagnostic criteria.

  1. Repeated knee pain in the past month
  2. X-ray showed narrowing of articular space, subchondral sclerosis and/or cystic degeneration, and formation of osteophyte at articular margin.
  3. Joint fluid (\> 2 times) is cool and sticky, WBC \< 2000/ml
  4. Age over 40
  5. Morning stiffness less than 30 minutes
  6. Bone fricative (sensation) during exercise According to 1+2 or 1+3+5+6 or 1+4+5+6, OA of knee joint can be diagnosed.
  7. The informed consent has been signed

Exclusion Criteria:

* (1) Joint pain caused by other causes (infection, hip, lumbar and other diseases) (2) Secondary arthritis (rheumatoid arthritis, ankylosing spondylitis, etc.) (3) Severe internal medical complications and other inability to participate in the research (4) Pain in other parts exceeds joint pain (5) Contraindications to diclofenac use: active peptic ulcer/allergy/induced asthma (6) Assessment may not complete the study

Primary outcomes:
measure: adherence
timeFrame: 6-8 weeks
measure: pain relief rate
timeFrame: 6-8 weeks
Secondary outcomes:
measure: womac score
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Xicheng District
Study officials:
affiliation: Peking University People's Hospital
name: Jianhao Lin, M.D.
role: STUDY_CHAIR
affiliation: Peking University People's Hospital
name: Yudian Qiu, M.D.
role: STUDY_DIRECTOR
References:
citation: da Costa BR, Reichenbach S, Keller N, Nartey L, Wandel S, Juni P, Trelle S. RETRACTED: Effectiveness of non-steroidal anti-inflammatory drugs for the treatment of pain in knee and hip osteoarthritis: a network meta-analysis. Lancet. 2016 May 21;387(10033):2093-2105. doi: 10.1016/S0140-6736(16)30002-2. Epub 2016 Mar 18.
Clinical trial NCT00404105: A Comparison of PRK and LASIK for Correction of Myopia
Official title: A Prospective, Randomised Trial of Photo-Refractive Keratectomy (PRK) and Laser-in-Situ-Keratomileusis (LASIK) for Correction of Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myopia
Keywords: Excimer laser
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2006-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares the precision and accuracy of two laser refractive techniques, PRK and LASIK, for correction of nearsightedness between -6 and -8 diopters.


Eligibility criteria: Inclusion Criteria:

* spherical equivalent subjective refraction between -6.00 and -8.00 diopters
* age between 18 and 49 years
* desire for having laser refractive surgery

Exclusion Criteria:

* present or past eye disease excluding myopia
* pregnant or lactating woman

Primary outcomes:
measure: Uncorrected visual acuity
measure: Best corrected visual acuity
measure: Best spectacle correction
Secondary outcomes:
measure: IOP
measure: Corneal thickness
measure: Corneal wavefront aberrations
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Ophthalmology, Aarhus Sygehus NBG
Study officials:
affiliation: Department of Ophthalmology, Aarhus Sygehus, University of Aarhus
name: Jesper Hjortdal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ivarsen A, Hjortdal J. Seven-year changes in corneal power and aberrations after PRK or LASIK. Invest Ophthalmol Vis Sci. 2012 Sep 6;53(10):6011-6. doi: 10.1167/iovs.12-10208.
Clinical trial NCT03664505: Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars
Official title: Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Scar
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 10
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: Burn scars are treated with compression garments. These are produced based on manual measure data. The aim of this study is to evaluate correct fitting, wearing comfort, suitability for daily use and scar properties after using garments produced on base of measuring data from scanning in comparison to manual measured data.

Detailed description: In plastic and reconstructive surgery, treatment of burn scars is still challenging, because excessive and hypertrophic scarring can occur. Burn garments are usually used to reduce such scarring. However, measure are taken manually by a measuring tape using interpolation. Therefore, compression garments produced on base of 3D surface imaging using a scanning system are compared to compression garments based on manually measurements regarding correct fitting, wearing comfort, suitability for daily use and scar properties.

Eligibility criteria: Inclusion Criteria:

* Burn scars on an arm after IIa-III. burn (1-30% surface area)
* Indication for burn garments
* Experience in using burn garments

Exclusion Criteria:

* Consume of pain killer
* Medication with cortisone or immun suppressive therapy
* Psychiatric disease

Primary outcomes:
measure: Fitting of the garment (on a numeric rating scale 0-10)
timeFrame: 3 months
Secondary outcomes:
measure: Comfort of the garment (on a numeric rating scale 0-10)
timeFrame: 3 months
measure: Daily use of the garment (on a numeric rating scale 0-10)
timeFrame: 3 months
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University Hospital Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT03318705: Testing Latest Version of NidekRS3000Adv
Official title: Testing Latest Version of NidekRS3000Adv
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Doheny Image Reading Center
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control subjects with no ocular problems, with whom no record review will be conducted, but imaging will be conducted with study devices.

Brief summary: The investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.


Eligibility criteria: Inclusion Criteria:

* Healthy participants
* 18 years old or older

Exclusion Criteria:

* Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging
* subjects who are unable to maintain retinal fixation on a specified target
* subjects unable to achieve sufficient pupil dilation and alignment stability for imaging to take place
* subjects with media opacity which preclude high quality imaging will be excluded.
* vulnerable subjects
* subjects under 18
* pregnant subjects
* economically and educationally disadvantaged subjects
* decision impaired subjects
* homeless subjects

Primary outcomes:
measure: Ocular vascularization
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Doheny Eye Centers UCLA
state: California
Study officials:
affiliation: Doheny Eye Institute
name: Srinivas Sadda, MD
role: PRINCIPAL_INVESTIGATOR
References: