louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03206359: GADD34 and Type I IFN Response Genes in SLE
Official title: Evaluation of GADD34 and Type I IFN Response Gene Expression in Patients Suffering From Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: Unfolded Protein Response
GADD34
Type I IFN
IFN response genes
Type II IFN
anti-DNA autoantibodies
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 90
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: Patients suffering from systemic lupus erythematosus

Brief summary: GADD34 (Growth Arrest and DNA Damage inducible-protein) is a regulatory subunit of PP1 (phosphatase 1) phosphatase which dephosphorylates eIF2alpha (eucaryotic initiation factor 2 alpha subunit), representing a negative feedback loop of the unfolded protein response (UPR). Moreover, GADD34 is necessary for type I interferon (IFN) production in response to viral infection in murine models. We investigate here the expression of GADD34 in systemic lupus erythematosus (SLE), in which type I IFN has an important pathogenic role.

We report a case-control study on GADD34 gene expression in PBMC (peripheral blood mononuclear cells) of SLE patients (n=60) and age- and sex-matched healthy controls (n=30). The level of GADD34 gene expression, as well as of type-I IFN response genes in PBMC is measured by quantitative PCR.


Eligibility criteria: Inclusion Criteria:

* Man and woman over 18 years old.
* Patients suffering from SLE (SLICC criteria)
* Patients having given their "Non-opposition"
* Patients with social security affiliation (required in France)

Exclusion Criteria:

* Patients suffering from other auto-immune disease (except SAPL, thyroiditis, and Gougerot Sjogren syndrome)
* Patients with viral infection within 15 days
* People with special protection (defined in articles L1121-§5-8 and articles L3212-§1-3 of French health care law)

Primary outcomes:
measure: GADD34 expression in SLE patients
timeFrame: 4 years
Secondary outcomes:
measure: GADD34 and IFN response gene expression
timeFrame: 4 years
measure: GADD34 expression and pathology activity
timeFrame: 4 years
measure: GADD34 expression and pathology activity
timeFrame: 4 years
measure: CHOP and BiP expression
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02958059: Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biliary Obstructive Disease Such as Choledocholithiasis
Benign Biliary Stricture
Peri-ampullary Cancer
Bile Duct Cancer Resectable
Klatskin Tumor
Keywords: ERCP
prophylaxis
antibiotics
infection
cholangitis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that allows minimally invasive management of biliary and pancreatic disorders. However, the incidence of infectious complication of ERCP is considerable. Transient blood stream infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection accounts for about 10% of the major complications associated with mortality.

Although prophylactic use of antibiotics is generally not recommend in all cases, debates about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is recommend in case of ERCP that incomplete biliary drainage is expected.

In this study, researchers will use prophylactic antibiotics in patients with biliary obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected based on the data of our institution, and administered to patients before ERCP procedure.


Eligibility criteria: Inclusion Criteria:

* Patients with biliary obstructive disease (Benign or Malignant)
* 19 year-old and older than 19 year-old

Exclusion Criteria:

* Younger than 19 year-old
* Patients with leukocytosis (WBC ≥ 11,000/mm3)
* Body temperature ≥ 38 °C within 72 hours before ERCP
* History of antibiotics administration due to cholangitis, cholecystitis or sepsis within 72 hours before ERCP
* Pregnancy women
* Patients with allergy to beta-lactam

Primary outcomes:
measure: Rate of complication that related with infection.
timeFrame: within 10 days
Secondary outcomes:
measure: Rate of post-ERCP cholangitis
timeFrame: within 10 days
measure: Grade of post-ERCP infectious complication
timeFrame: within 10 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university of medical center
Study officials:
References:
Clinical trial NCT00471159: A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.
Official title: A Randomized Phase 2 Clinical Trial Of Docetaxel With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

* Female patients with confirmed advanced breast cancer.
* Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.
* Patients with adequate general well-being, kidney and liver function.

Exclusion Criteria:

* Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study.
* Patients who have had prior chemotherapy for advanced breast cancer.
* Patients of child-bearing potential who are unwilling to use contraception.

Primary outcomes:
measure: Progression-free survival
measure: Tumor assessment every 6 weeks until disease progression
Secondary outcomes:
measure: Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression
measure: Overall Survival - Patients will be followed for survival
measure: Overall safety profile -Targeted questions to patients throughout study, Weekly blood sampling during treatment, every 3 weeks during follow-up, Urine sample every 3 weeks during treatment and follow-up
measure: Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02708459: Transversus Abdominus Plane Block in Living Donor Hepatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Living Donor Hepatectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 90
Sex: ALL
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: Comparing different drugs used in Transversus abdominus plane analgesia after donor hepatectomy. Patients will be divided into three groups; control group, Bupivecaine group, and Dexmedetomedine group according to the used drug

Detailed description: Transversus abdominus plane block for postoperative analgesia after donor hpatectomy surgery using three different drugs control group, Bupivecaine group, and Dexmedetomedine group

Eligibility criteria: Inclusion Criteria:

* all living hepatectomy donors in Mansoura liver transplantation program

Exclusion Criteria:

* refusal known sensetivity to used drugs

Primary outcomes:
measure: postoperative morphine (mg) consumption in 1st 48 hours
timeFrame: 48 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahleya
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References:
Clinical trial NCT05164159: The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy
Official title: The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Cholecystitis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 274
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is conducted to determine whether the occurrence of hypotension is reduced by the combined use of remimazolam and remifentanil compared to the conventional combination use of propofol and remifentanil. Patients enrolled in the study are infused continuously with either propofol or remimazolam from the start of anesthesia to the end of surgery.


Eligibility criteria: Inclusion Criteria:

1. patients 19 years of age or older
2. the American Society of Anesthesiologists classification 1-3
3. patients undergoing laparoscopic cholecystectomy at Severance Hospital

Exclusion Criteria:

1. Emergency surgery,
2. patients with heart disease or arrhythmias,
3. patients undergoing concurrent surgery other than laparoscopic cholecystectomy,
4. obesity (BMI\>30),
5. patients who were admitted on the surgery day,
6. foreigners,
7. illiteracy

Primary outcomes:
measure: Percent of patients with hypotension event
timeFrame: from start of drugs to end of anesthesia on the surgery 1 day
Secondary outcomes:
measure: time-weighted average of hypotension
timeFrame: from start of drugs to end of anesthesia on the surgery 1 day
measure: dose of Norepinephrine or nicardipine
timeFrame: from start of drugs to end of anesthesia on the surgery 1 day
measure: difference of QOR-40 score
timeFrame: Baseline (preoperative period) and Postoperative day 1
measure: Heart rate variability
timeFrame: from start of drugs to end of anesthesia on the surgery 1 day
measure: Sedline(Psi)
timeFrame: from start of drugs to end of anesthesia on the surgery 1 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Bon-Nyeo Koo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04442100: The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
Official title: The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Valve Diseases
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality

Detailed description: The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality. Antithrombotic therapy after new biological valve prosthesis is studied. Transesophageal ultrasound is used for assessment of aortic strain, left ventricular strain, and 3D reconstruction of implanted bioprosthesis. The quality of life of patients is assessed using SF36 questionnaire. Heart failure after surgery is assessed by six-minute walking test and plasma BNP level.

Eligibility criteria: Inclusion Criteria:

1. aortic valve disease requiring surgical disease patients without symptoms with severe aortic stenosis - indexed area of the opening less than 0.5 cm2 / m2, average gradient more than 40 mm RT. Art;

   o patients who require coronary artery bypass grafting with moderate aortic stenosis - indexed area of the hole 0.5 - 1 cm2 / m2, the average gradient is more than 20 mm RT. Art., Regardless of symptoms;patients with symptoms of aortic stenosis, regardless of the severity of stenosis)
2. mitral valve disease requiring surgical disease

Exclusion Criteria:

1. the need for prosthetics of two or more valves
2. patients with a decrease in LVEF of less than 45%;
3. the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death
4. high pulmonary hypertension (SDJ above 60 mm Hg. Art.);
5. the diameter of the ascending aorta is more than 45 mm;
6. unwillingness of the patient to participate in the study.

Primary outcomes:
measure: death
timeFrame: 10 years after surgery
measure: prosthetic complications
timeFrame: 10 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Tomsk National Research Medical Center of the Russian Academy of Sciences
state: Tomsk Region
Study officials:
affiliation: Tomsk National Research Medical Center of the Russian Academy of Sciences
name: Boris N. Kozlov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05259800: Peppermint Oil for Urinary Retention
Official title: Evaluating the Use of Peppermint Oil for Postpartum Women With Urinary Retention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Retention
Keywords: peppermint oil
postpartum
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled study will be conducted, with two arms. Postpartum women experiencing urinary retention will be randomized into one of the two following arms:

* Arm 1: Subjects will be exposed to vapor of peppermint oil
* Arm 2: Subjects will be exposed to vapor of placebo (mineral oil) Outcome variables include resolution of urinary retention, time to spontaneous urination, volume of spontaneous urination, frequency of urinary catheterization, and patient satisfaction.

Detailed description: The purpose of the study is to determine if the use of peppermint oil among postpartum women experiencing urinary retention will increase spontaneous urination and decrease the need for catheterization. A randomized controlled study will be conducted, with two arms. Subjects will be randomized into one of the two following arms:

* Arm 1: Subjects will be exposed to vapor of peppermint oil
* Arm 2: Subjects will be exposed to vapor of placebo (mineral oil) Outcome variables include resolution of urinary retention, time to spontaneous urination, volume of spontaneous urination, frequency of urinary catheterization, and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* 1. 18 years old or older 2. English speaking 3. Admitted to Bethesda North Mom Baby Unit 4. Postpartum 5. Experiencing urinary retention - defined as meeting at least one of the following criteria:

  * More than 6 hours after delivery or foley catheter removal without being able to spontaneously void
  * Symptomatic urinary retention without being able to spontaneously void
  * Change in fundal height or position without being able to spontaneously void 6. Bladder scan showing bladder containing 400mL or more urine

Exclusion Criteria:

1. Allergy to peppermint
2. Asthma
3. Active herpes lesions
4. Seizure disorder
5. Not able to void in toilet (ex: requiring use of bed pan to void)

Primary outcomes:
measure: Percent of patients with urinary retention resolved
timeFrame: 10 minutes
Secondary outcomes:
measure: Time to spontaneous urination
timeFrame: 1 hour
measure: Volume of spontaneous urination
timeFrame: 1 hour
measure: Incidence of urinary catheterization
timeFrame: 1 hour
measure: Patient satisfaction
timeFrame: 1 hour
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02694900: Single-rescuer Pediatric Resuscitation
Official title: Comparison of Three Different Chest Compressions Methods During Pediatric Cardiopulmonary Resuscitation: A Pilot, Randomized Crossover Manikin Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Compression
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this pilot study was to compare the manual chest compressions (CC) versus CC feedback device TrueCPR vs mechanical CC device LifeLine ARM during simulated pediatric cardiopulmonary resuscitation


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* maximum 1 year of work experience in medicine
* minimum 10 clinical resuscitations
* paramedics, nurses, physicians

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
* pregnancy

Primary outcomes:
measure: chest compressions effectiveness
timeFrame: 1 day
Secondary outcomes:
measure: Depth
timeFrame: 1 day
measure: Pressure point
timeFrame: 1 day
measure: Complete pressure release
timeFrame: 1 day
measure: Rate of chest compressions
timeFrame: 1 day
measure: Ease-of-use
timeFrame: 1 day
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Łukasz Szarpak
Study officials:
References:
citation: Truszewski Z, Szarpak L, Kurowski A, Evrin T, Zasko P, Bogdanski L, Czyzewski L. Randomized trial of the chest compressions effectiveness comparing 3 feedback CPR devices and standard basic life support by nurses. Am J Emerg Med. 2016 Mar;34(3):381-5. doi: 10.1016/j.ajem.2015.11.003. Epub 2015 Nov 4.
Clinical trial NCT00894400: Characterisation of Fractionated Electrograms Critical for Maintenance of Atrial Fibrillation (AF)
Official title: Characterisation of Fractionated Electrograms Critical for Maintenance of AF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: AF
catheter ablation
fractionated electrogram
complex fractionated atrial electrogram (CFAE)
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2009-05-07
Enrollment: 20
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: The purpose of this study is to characterise which fractionated electrogram morphologies are important to target in the catheter ablation of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* patients with persistent AF listed for first time catheter ablation

Exclusion Criteria:

* age \< 18 years
* pregnancy
* contraindications to procedure
* recent myocardial infarction, coronary intervention, or cardiac surgery

Primary outcomes:
measure: change in AF cycle length when targeting fractionated electrograms of different morphology.
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts and The London NHS Trust
Study officials:
References:
citation: Hunter RJ, Diab I, Tayebjee M, Richmond L, Sporton S, Earley MJ, Schilling RJ. Characterization of fractionated atrial electrograms critical for maintenance of atrial fibrillation: a randomized, controlled trial of ablation strategies (the CFAE AF trial). Circ Arrhythm Electrophysiol. 2011 Oct;4(5):622-9. doi: 10.1161/CIRCEP.111.962928. Epub 2011 Aug 15.
Clinical trial NCT04010500: Speech Performance of Rugby Players When Using Different Types of Mouthguard
Official title: Speech Performance of Rugby Players When Using Different Types of Mouthguard
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Speech
Keywords: dental trauma
rugby
mouthguard
speech
contact sports
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participants will articulate phonemes with plosive sounds (/p/, /b/, /d/ and /t/) for the following conditions in a pre-determined sequence: (i) not using mouthguard; (ii) using a 'boil and bite' mouthguard; and (iii) using a custom-fitted mouthguard. A washout interval of one hour will be implemented between conditions.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participation in contact sports is linked to an increased risk of dental injuries. To reduce the risk and severity of sports-related dental injuries, mouthguards are often recommended to be worn during training and competition. However, athletes often complain that they cannot talk properly when using mouthguards. It is hypothesized that speech performance differs when using different types of mouthguards. A group of female national rugby players will be asked to pronounce four Malay words with plosive sounds (/p/, /b/, /d/ and /t/) repeatedly in three conditions: (i) when not using any mouthguard, (ii) when using 'boil and bite' mouthguard, and (iii) when using custom-fitted mouthguard. The sounds will be recorded for spectrographic analysis. The difference in mean voice onset time between conditions will be assessed.


Eligibility criteria: Inclusion Criteria:

* adult female aged 18 years old and older
* currently representing the nation and participating actively in rugby
* native speakers of Malay (national language)

Exclusion Criteria:

* did not play rugby within the last six months
* edentulism
* used a mouthguard, orthodontic appliance or removable prosthodontics appliance within the last six months
* known history of allergy to polymers
* medical problems (ASA classification 3 and above)

Primary outcomes:
measure: Mean voice onset time
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Universiti Kebangsaan Malaysia
Study officials:
References: