louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02698488: Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology
Official title: Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Embryo Selection
IVF
Morphology
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Acibadem Fulya Hospital
name: Marmara University
First posted: 2016-03-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Identification of the embryo with the highest potential to implant and establish an ongoing pregnancy is a primary aim in human assisted reproduction. This task is undertaken every day by embryologists worldwide during the treatment of couples that wish to conceive by IVF. The optimal scenario is the transfer of a single embryo which gives rise to a singleton pregnancy. The current limitations in determination of embryos that have the highest implantation potential probably contribute to the low rates of pregnancy during IVF treatments. Hence, since the beginning of IVF, how to improve embryo selection has been a 'hot research topic.' Morphology has been a very obvious parameter to assess embryos as it provides a chance to evaluate them from the oocyte stage all the way to the blastocysts stage. Hence, in the first era of IVF, there were number of studies that evaluated this parameter and associated morphology with IVF success rates. On the other hand, it has been previously stated that the slight increase in pregnancy rates during IVF treatment is mostly likely a result of better practices in laboratory than morphological evaluation. Due to the limitations of morphological evaluation, several researchers have investigated adjunctive non-invasive approaches for the assessment of the embryo, such as the metabolomic profiling.

Recently mass spectroscopic (MS) approaches have been utilized in limited settings. Samples needed minimal preparation; analytical analysis was rapid and large amounts of data was available. Hence, MS might be a promising approach for metabolomic profiling of embryo culture media.


Eligibility criteria: Inclusion Criteria:

* any infertility etiology
* good previous response to IVF with ≥1 embryo

Exclusion Criteria

* poor response to IVF previously

Primary outcomes:
measure: Clinical Pregnancy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University School of Medicine
Study officials:
affiliation: Istanbul University School of Medicine
name: Ercan Bastu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05572788: Rectal Indomethacin to Prevent Acute Pancreatitis in EUS-FNA of Pancreatic Cysts
Official title: Randomized Trial of Rectal Indomethacin to Prevent Acute Pancreatitis in Patients Undergoing Endoscopic Ultrasound-guided Fine Needle Aspiration of Pancreatic Cysts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cyst
Pancreatitis, Acute
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this randomized trial is to compare the rate of post-procedure pancreatitis in patients undergoing EUS-FNA of pancreatic cysts; patients will receive either a single dose of indomethacin or placebo administered rectally, during EUS-FNA.

Detailed description: Pancreatic cysts are pre-malignant lesions and are being increasingly diagnosed on cross-sectional imaging. Endoscopic ultrasound (EUS) is performed to further evaluate pancreatic cysts, and fine needle aspiration (FNA) is conducted to obtain a sample of the cystic fluid for analysis and examination for malignant cells. Acute pancreatitis is a complication of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, which can lead to significant morbidity and substantial health care costs. The aim of this randomized trial is to compare the rate of post-procedure pancreatitis in patients undergoing EUS-FNA of pancreatic cysts; patients will receive either a single dose of indomethacin or placebo administered rectally, during EUS-FNA.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Suspected or confirmed pancreatic cyst seen on imaging, requiring EUS-FNA

Exclusion Criteria:

* Unable to obtain consent from the participant or the participant's legally authorized representative (LAR)
* Intrauterine pregnancy
* Hypersensitivity reaction to Aspirin or NSAIDs
* Patients with known history of chronic pancreatitis
* Patients with known renal failure

Primary outcomes:
measure: Rate of post-procedure pancreatitis following EUS-guided fine needle aspiration of pancreatic cysts
timeFrame: 30 days
Secondary outcomes:
measure: Rate of procedure-related adverse events
timeFrame: 30 days
measure: Disease-related adverse events
timeFrame: 30 days
measure: Rate of mild, moderate and severe pancreatitis post-FNA
timeFrame: 30 days
measure: Length of hospitalization in any patient hospitalized with any adverse event
timeFrame: 30 days
measure: Length of hospitalization in any patient hospitalized with acute pancreatitis
timeFrame: 30 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: Orlando Health, Digestive Health Institute
name: Ji Young Bang, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01641588: Are You Sitting Down: Cognitive Exectutive Function Task Comparison Between Seated and Standing Positions
Official title: Are You Sitting Down: Cognitive Exectutive Function Task Comparison Between Seated and Standing Positions Using Assessments From CNS Vital Signs Test Battery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: (Focus) Posture Effect on Cognitive Performance
Keywords: cognitive executive function
posture
cognitive performance
heart rate
eeg
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: Royal Academy of Engineering
name: Microsoft Research
First posted: 2012-07-17
Enrollment: 19
Sex: MALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this trial has been to explore the effects of self-positioning on cognitive performance in the work environment using a standardized cognitive test battery to evaluate executive function under two conditions: sitting and standing.

Detailed description: The aim of this trial has been to explore the effects of self-positioning on cognitive performance in the work environment using a standardized cognitive test battery to evaluate executive function under two conditions: sitting and standing.

Methods: This counterbalanced controlled trial involved 17 men (mean age +/-SD: 29.8 +/- 5.5) all with a science background and graduate degrees. The participants were accustomed to working in an open environment and none of whom currently using standing desks. We used a modified version of the CNS Vital Signs (CNSVS) test battery to assess cognitive executive function (CEF) in two typical work positions - standing and seated. Participants were randomly assigned to a standing or seated position to begin the testing procedure. Upon completion of the first test round they were instructed to rest for 10 min. in a dark room with no distractions before commencing the second round of testing positioned in the alternate fashion. The main outcome measure was a CNSVS score in each of the six CEF domains in the two different work positions

Eligibility criteria: Inclusion Criteria:

* male
* computer savvy
* advanced education degree

Exclusion Criteria:

* ADD
* on any medication
* currently a person who uses a standing desk

Primary outcomes:
measure: evidence of postural effect on cognitive performance
timeFrame: within the hour
Secondary outcomes:
measure: Interaction between posture and phyiological state against cognitive executive function performance
timeFrame: with the hour
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University of Southampton
state: Hampshire
Study officials:
affiliation: University of Southampton
name: m.c. schraefel, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04751188: A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
Official title: Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Biliary Cirrhosis
Keywords: ursodeoxycholic acid
Bezafibrate
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2021-02-12
Enrollment: 11
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: Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation.

The main objective of the study is to evaluate safety and efficacy of bezafibrate plus ursodesoxicolic acid in patients with PBC and inadequate response to UDCA.


Eligibility criteria: Inclusion Criteria:

* PBC diagnosis (consistent with American Association for the Study of Liver Disease \[AASLD\]:

  * History of elevated alkaline phosphatase levels.
  * Anti-mitochondrial antibodies positivity
  * Histopathologic evidence of nonsuppurative cholangitis and destruction of small or medium- sized bile ducts.
* Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day).
* Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria.
* Written informed consent.
* Age ≥ 18 years.

Exclusion Criteria:

* Hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepatic encephalopathy).
* Coexistence autoimmune hepatitis.
* Bilirrubin \>3mg/dl.
* For females, pregnancy or breast-feeding.
* Hepatocellular carcinoma.
* History or presence of spontaneous bacterial peritonitis.

Primary outcomes:
measure: Biochemical response
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life
timeFrame: Baseline and 6 months later
measure: Pruritus intensity
timeFrame: Baseline and 6 months later
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: Instituto Mexicano de Seguro Social
Study officials:
References:
Clinical trial NCT01752088: Repair of Subscapularis Tear :Clinical Results and MRI Analysis
Official title: Arthroscopic Repair of Subscapularis Tear :Clinical Results and MRI Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rupture Subscapularis Tendon
Keywords: apularis, MRI clinical, results
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from rotator cuff injury will be scheduled for an arthroscopic procedure

Brief summary: This study is to evaluate the magnetic resonance imaging (MRI) and clinical results of arthroscopic repair of subscapularis tears

Detailed description: ROM UCLA Constant ASES VAS MRI Goutallier

Eligibility criteria: Inclusion Criteria:

- Patients suffering from rotator cuff injury scheduled for an arthroscopic procedure. A partial- or full-thickness subscapu-laris tendon tear

Exclusion Criteria:

- revision repairs or open repairs.

Primary outcomes:
measure: Clinical results and MRI analysis
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Guoqing Cui, MD
role: STUDY_CHAIR
References:
citation: Denard PJ, Jiwani AZ, Ladermann A, Burkhart SS. Long-term outcome of a consecutive series of subscapularis tendon tears repaired arthroscopically. Arthroscopy. 2012 Nov;28(11):1587-91. doi: 10.1016/j.arthro.2012.02.031. Epub 2012 May 24.
Clinical trial NCT02407288: tDCS as an add-on Treatment in SSRI-resistant OCD
Official title: Transcranial Direct Current Stimulation as an add-on Treatment in SSRI-resistant Obsessive Compulsive Disorder : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder

Detailed description: Total number of scheduled patients to be recruited: 46 We used the effect size of the study of Ruffini and colleagues (2009) in which rTMS was used to target the left orbito frontal cortex to calculate the number of patients to be recruited. With a risk alpha of 5%, a power of 80%, the number of patients to be included was 46 with an anticipated rate of 10% of lost to follow-up patients. (calculation was made on the http://www.spc.univ-lyon1.fr/mfcalc/NSN/assistant.htm)

Statistical analysis to address the primary and secondary objectives:

Chi squared test will be applied for quantitative data.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with OCD according to DSM V criteria
* YBOCS score of 16 and above, stable (\<20% of variation) during at least one month.
* have received for at least 12 weeks of which 6 weeks was either at the maximum tolerated dose or alternatively the manufacturer's recommended maxi- mum daily dose.
* age between 18 and 70
* voluntary and competent to consent

Exclusion Criteria:

* Major depressive disorder diagnosed with the DSM V criteria with a MADRS score \>30 (actual)
* schizophrenia and other psychotic disorder
* drugs or alcohol abuse
* acutely suicidal
* significant head injury, or of any neurosurgical procedure with implanted material
* pregnant women

Primary outcomes:
measure: score improvement on the Yale Brown Obsessive and Compulsive Scale after one month
timeFrame: 1 month after treatment
Secondary outcomes:
measure: Number of responders on the YBOCS
timeFrame: 1 month after treatment
measure: score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier
Study officials:
affiliation: CH le Vinatier
name: Bation Remy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05233488: Effect of Different Ultrasound Doses on Median Nerve Conduction Parameters
Official title: Effect of Non-thermal Parameters of Ultrasound on Median Motor Nerve Conduction Velocity.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Entrapment Neuropathies
Keywords: Pulsed Ultrasound
Nerve conduction parameters.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four groups; First group receives pulsed US 1 W/cm2 10% duty cycle. Second group receives pulsed US 1 W/cm2 50% duty cycle. Third group receives pulsed US 3 W/cm2 10% duty cycle. Fourth group receives pulsed US 3 W/cm2 50% duty cycle.
Primary purpose: TREATMENT

Brief summary: The current study investigates the effect of different doses of pulses ultrasound therapy on different nerve conduction parameters of the median nerve in healthy volunteering subjects.

Detailed description: In the current study, we apply pulsed ultrasound therapy on median nerves of healthy volunteer subjects, at 1 W/cm2 10% duty cycle, 3 W/cm2 10% duty cycle, 1 W/cm2 50% duty cycle, and 3 w/cm2 50% duty cycle. Parameters of median nerve conduction study, Latency, amplitude, area, duration and forearm NCV are recorded before and after application of ultrasound therapy.

Eligibility criteria: Inclusion Criteria:

1. 120 hands of 60 subjects of both genders with age range 18: 24 years.
2. Subjects assigned will be apparently healthy subjects with no neurological or neuromuscular history affecting the upper limb.

Exclusion Criteria:

1. Peripheral polyneuropathy.
2. Diabetes mellitus.
3. Previous surgeries or median and/or ulnar nerve release.
4. Cervical radiculopathy.
5. Median or ulnar entrapment neuropathies.
6. Previous or current pregnancies.

Primary outcomes:
measure: CMAP distal latency
timeFrame: Immediately after application
measure: CMAP amplitude
timeFrame: Immediately after application
measure: CMAP duration
timeFrame: Immediately after application
measure: Nerve conduction study
timeFrame: Immediately after application
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Amr S Shalaby, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02519088: A New Approach to a Personalized Patient Blood Management Program (pPBM) in Total Hip Arthroplasty (THA)
Official title: A New Approach to a Personalized Patient Blood Management Program in Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Anemia
Keywords: Homologous Blood Transfusion
Total Hip Replacement
Patient Blood Management
Lead sponsor: Krankenhaus der Barmherzigen Brüder Trier
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who electively underwent primary THA in 2013 and 2014

Brief summary: The study evaluates the patient related risk and predictive factors concerning perioperative homologous blood cell transfusion (erythrocyte concentrate ) in THA patients in one EndoCert max-certified orthopedic hospital in Germany.

A patient oriented preoperative decision-making algorithm (a personalised Patient Blood Management or pPBM App) will be developed as a new patient-safety blood-sparing strategy.

The aim is to increase the patient safety by using the pPBM App and to reach a more efficient management of resources.

Detailed description: Retrospective audit of 470 consecutive primary THA in 2013 and 2014

Eligibility criteria: Inclusion Criteria:

* primary THA on patients with coxarthrosis

Exclusion Criteria:

* any kind of old or acute fractures about the basin and hip
* combined surgery, like first extracting a femur nail and than undergoing THA
* any other kind of combined or simultaneous surgery
* any kind of coagulopathy

Primary outcomes:
measure: Events and circumstances of Homologous Blood Transfusion (erythrocyte concentrate transfusion)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes:
measure: pPBM Computer Simulation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Other outcomes:
Locations:
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
state: Rheinland-Pfalz
Study officials:
affiliation: Krankenhaus der Barmherzigen Brüder Trier
name: Ion-Andrei Popescu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04071288: Burch Colposuspension and Mid-urethral Sling Operations
Official title: Comparison of Burch Colposuspension and Mid-urethral Sling Operations for Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incontinence
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total laparoscopic hysterectomy was planned for benign causes, Patients who underwent simultaneous operation for incontinence

Brief summary: Stress urinary incontinence is common in women. the treatment of this condition is surgery. investigators add stress incontinence surgery to patients who undergo total laparoscopic hysterectomy for benign reasons.

Depending on the patient's general condition and indications, the operation can be performed by vaginal approach, as well as mid-urethral sling operations and laparoscopic burch colposuspension.

The researchers aimed to compare these two types of operations performed on patients. In this way, the superiority and disadvantage of each other in two procedures will be demonstrated.


Eligibility criteria: Inclusion Criteria:

* A total laparoscopic hysterectomy was planned for benign causes,
* Patients scheduled for simultaneous operation for incontinence

Exclusion Criteria:

* Patients previously operated for urinary incontinence
* Patients whose diagnosis of stress urinary incontinence is uncertain
* Patients with urinary tract infection

Primary outcomes:
measure: recurrence
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References: