louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03934190: Inner Nuclear Macular Microcyst is a Risk Factor for Macular Cystoid Changes After Phacoemulsification in Eyes With Previous Vitrectomy and Macular Pucker Removal
Official title: Inner Nuclear Macular Microcyst is a Risk Factor for Macular Cystoid Changes After Phacoemulsification in Eyes With Previous Vitrectomy and Macular Pucker Removal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Pucker
Macular Cyst
Keywords: macular edema
pseudophakic cystoid macular edema
macular pucker
internal limiting membrane peeling
pars plana vitrectomy
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The general medical history of the patients was evaluated preoperatively. Comprehensive ophthalmological examinations including BCVA measurements and funduscopic examinations were performed at each visit. SD-OCT (Cirrus HD-OCT, Carl Zeiss Meditec, Dublin, CA) was used to measure the central macular thickness (CMT) and structural changes preoperatively, and at 1 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively

Brief summary: To evaluate the visual acuity, macular thickness, morphological changes after cataract surgery in eyes with previous vitrectomy for macular pucker. Associated risk factors were also investigated.


Eligibility criteria: Inclusion Criteria:

* Patients had macular pucker surgery before cataract surgery.
* Follow up over 1 year.

Exclusion Criteria:

* Patients had any surgical complications such as posterior capsule rupture, vitreous loss, prolapse through the wound or iris trauma
* Patients had diabetes mellitus.
* Patients had uveitis or other inflammatory eye disease.
* Patients had history of retinal vein occlusion.
* Patients had retinal detachment; or previous vitrectomy for a disease other than macular pucker.

Primary outcomes:
measure: Wilcoxon Signed-Rank test
timeFrame: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year
Secondary outcomes:
measure: visual acuity
timeFrame: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Changhua Christian Hospital
name: San-Ni Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01540890: Impairment of Sleep and Pattern of Breathing Before and After Opioid Withdrawal in Comparison to Patients Without Opioid Withdrawal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Architecture Under Opioid Medication
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: inpatients with chronic pain

Brief summary: Main of the study is to assess the influence of high-dose opioids on the sleep architecture and patterns of breathing using non-invasive polysomnographic measurements before and after opioid withdrawal in patient who undergo opioid withdrawal independently from the present study. These data will be compared to polysomnographic data of patients under opioid treatment who do not undergo opioid withdrawal as well as to patients without opioid treatment.


Eligibility criteria: Inclusion Criteria:

* older than 18 year, indication for opioid withdrawal (cohort 1), opioid intake (cohort 1 and 2)

Exclusion Criteria:

* plaster allergic reactions, opioid withdrawal (cohort 2), opioid intake (cohort 3)

Primary outcomes:
measure: frequency of an abnormal apnoea-hypnoea index
timeFrame: 3 weeks
Secondary outcomes:
measure: changes of the sleep duration and architecture
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Pain Medicine
Study officials:
References:
Clinical trial NCT01860690: BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success
Official title: BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ectopic Pregnancy
Keywords: MTX
Ectopic pregnancy
medical treatment
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators want to compeer BHCG levels after Methotrexate ( MTX). treatment for Ectopic pregnancy in days 4 and 7 after MTX. to day 10 . The hypothesis is that "BHCG" level in day 10 is the best indicator for treatment success , superior to day 4 and 7 . According to the investigators impression BHCG level rises in days 4 and 7 due to destruction of the trophoblast tissue , and only day 10 is an indicator for treatment success


Eligibility criteria: Inclusion Criteria:

* patients with ectopic pregnancy
* healthy
* hemodynamic stable
* first ectopic

Exclusion Criteria:

* hemodynamic non-stable
* abnormal liver or kidney function
* allergy reaction to MTX

Primary outcomes:
measure: To measure the change of levels of "BHCG" in patients receiving Methotrexate for treatment of ectopic pregnancy in days 4, 7, and 10 post treatment
timeFrame: the change of levels in days 4, 7, and 10 post MTX injection
Secondary outcomes:
Other outcomes:
Locations:
city: Kefar-saba
country: Israel
facility: Dr. Zvi Klein
Study officials:
References:
Clinical trial NCT01343290: The Effect of Food on the Administration of Canagliflozin in Healthy Adult Volunteers
Official title: A Single-Dose, Open-Label, Randomized, 2-Period, 2-Sequence, Crossover Study to Determine the Effect of Food Coadministration on the Pharmacokinetics of 300 mg Canagliflozin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Canagliflozin (JNJ-28431754)
Pharmacokinetic
Oral Bioavailability
Food effect
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2011-04-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of food on the absorption of canagliflozin in the body when canagliflozin is taken with and without food by healthy volunteers

Detailed description: This is a single-center, single-dose, open-label (volunteers will know the identity of assigned treatment), randomized (one of 2 study drug sequences assigned by chance) study to evaluate the oral bioavailability (the degree to which the drug is absorbed in the body when taken orally by mouth) of canagliflozin when taken with and without food in healthy volunteers. Healthy Volunteers will take 1 canagliflozin tablet orally for 1 day in 2 treatment periods (canagliflozin will be taken with food in 1 treatment period and canagliflozin will be taken without food in 1 treatment period); the 2 treatment periods will be separated by a 10- to 14-day washout period.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg

Exclusion Criteria:

* of or current medical illness deemed clinically significant by the Investigator (study physician)

Primary outcomes:
measure: Concentration of canagliflozin in plasma samples
timeFrame: For up to 8 days
Secondary outcomes:
measure: Adverse events reported
timeFrame: Up to approximately 34 days
measure: Vital signs measurements
timeFrame: Up to approximately 34 days
measure: Results from clinical chemistries performed
timeFrame: Up to approximately 34 days
measure: Results from 12-lead ECGs performed
timeFrame: Up to approximately 34 days
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Devineni D, Manitpisitkul P, Murphy J, Stieltjes H, Ariyawansa J, Di Prospero NA, Rothenberg P. Effect of food on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor, and assessment of dose proportionality in healthy participants. Clin Pharmacol Drug Dev. 2015 Jul;4(4):279-86. doi: 10.1002/cpdd.151. Epub 2014 Dec 11.
Clinical trial NCT03015090: Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline
Official title: Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline in Han and Uygur Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
CYP1A2
Theophylline
Lead sponsor: Kashgar 1st People's Hospital
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
First posted: 2017-01-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to determine whether common CYP1A2 gene polymorphisms effect metabolism of theophylline in Han and Uygur Patients with chronic obstructive pulmonary disease patients.


Eligibility criteria: Inclusion Criteria:

* Aged 18-75 years,Weight 40-80kg COPD patients, male or female; regularly visiting our hospital; taking a sustained-release preparation of theophylline continuously for at least 2 weeks

Exclusion Criteria:

* Patients with renal or hepatic dysfunction; Patients with congestive heart failure; Patients with hypothyroidism or hyperthyroidism; Patients currently taking drugs likely to effect theophylline metabolism or who had taken such drugs in the preceding week; Patients with extreme obesity Patients with very severe Chronic Obstructive Pulmonary Disease(COPD)

Primary outcomes:
measure: Plasma concentrations of theophylline
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Kashgar
country: China
facility: Kashgar 1st People's Hospital
state: Xinjiang
Study officials:
References:
Clinical trial NCT04161690: Evaluation of Dexketoprofen in Total Knee Arthroplasty
Official title: Evaluation of Dexketoprofen Given Intravenous or Intrathecal in Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postoperative Pain
Analgesia
Lead sponsor: KAT General Hospital
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions. Dexketoprofen is a new NSAID treating acute postoperative pain. The purpose of this study is to evaluate the analgesic effect when it is given intravenously or as part of the local infiltration analgesia in patients under spinal anesthesia undergoing unilateral total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* unilateral total knee arthroplasty
* accept to enter the study
* ASA score I or II
* hospitalization for at least 2 days

Exclusion Criteria:

* allergy in any given medications
* active gastrointestinal bleeding or other active bleeding
* history of peptic ulcer
* renal failure
* hepatic failure
* chronic heart failure

Primary outcomes:
measure: VAS Score in 8hours after surgery
timeFrame: 8h
measure: VAS Score 24hours after surgery
timeFrame: 24h
measure: VAS Score 48hours after surgery
timeFrame: 48h
measure: Total tramadol consumption the first 24hours
timeFrame: 24h
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Elena Nikolakopoulou
state: Kifissia
Study officials:
References:
Clinical trial NCT01291290: START - Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism
Official title: Thrombocyte Administration Versus no Thrombocytes to Patients With Ruptured Abdominal Aortic Aneurism Before Transport to Hospital With Vascular Surgical Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ruptured Abdominal Aortic Aneurism
Keywords: rAAA
Platelets
TEG
Massive bleeding
Coagulopathy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 420
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of platelet infusion prior to transfer to a vascular surgical department in patients with a ruptured abdominal aortic aneurism.


Eligibility criteria: Inclusion Criteria:

* diagnosed with rAAA either by clinical evaluation or CT or UL

Exclusion Criteria:

* formerly randomized in the study
* aneurism not ruptured during operation

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Acute myocardial infarction
timeFrame: 30 days
measure: Post operative kidney failure
timeFrame: 30 days
measure: Post operative pulmonary insufficiency
timeFrame: 30 days
measure: Length of stay in ICU
timeFrame: until discharged from ICU
measure: Length of stay in hospital
timeFrame: until discharged from hospital
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Oesterbro
Study officials:
name: Henning Bay Nielsen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00593190: Intracameral Gas SF6 (Sulfur Hexafluoride) Injection for Acute Hydrops in Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrops in Keratoconus
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intracameral Gas SF6 (Sulfur Hexafluoride) Injection for Acute Hydrops in Keratoconus


Eligibility criteria: Inclusion Criteria:

* Hydrops

Exclusion Criteria:

* Age \< 18 years old

Primary outcomes:
measure: Hydrops resulotion
timeFrame: weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
References:
Clinical trial NCT00759590: Comparison of Two Methods to Estimate the Lung Recruitment
Official title: Comparisons of Two Methods to Estimate the Lung Recruitment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome
Acute Lung Injury
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALI/ARDS patients

Brief summary: In this study the investigators aim to compare two common methods to estimate the lung recruitment in ALI/ARDS patients.


Eligibility criteria: Inclusion Criteria:

* ALI/ARDS

Exclusion Criteria:

* Barotrauma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Policlinico Hospital
Study officials:
affiliation: Policlinico Hospital
name: Davide Chiumello, MD
role: STUDY_CHAIR
References:
citation: Chiumello D, Marino A, Brioni M, Cigada I, Menga F, Colombo A, Crimella F, Algieri I, Cressoni M, Carlesso E, Gattinoni L. Lung Recruitment Assessed by Respiratory Mechanics and Computed Tomography in Patients with Acute Respiratory Distress Syndrome. What Is the Relationship? Am J Respir Crit Care Med. 2016 Jun 1;193(11):1254-63. doi: 10.1164/rccm.201507-1413OC.
Clinical trial NCT04690790: Pulmonary Nodule Localization Prospective Validation
Official title: Pulmonary Nodule Localization Under Thoracoscopic Surgery- a Machine Learning Based Retrospective Analysis and Prospective Validation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Video-assisted Thoracic Surgery
Pulmonary Nodules
Keywords: Video-assisted thoracic surgery
Thoracoscopy
Localization
Pulmonary nodules
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for thoracoscopic nodulectomy

Brief summary: Localization is the key for successful excision of small target nodules under thoracoscopy, but the procedure also brings risks to patients. However, the criteria is still unclear. The investigators will validate the prediction model produced by institutional retrospective analysis in the prospective cohort.

Detailed description: Excision of targeted lung nodules during thoracoscopy sometimes needs placing a mark before surgery. The procedure of mark placement (localization) could probably cause damages to the patients. However, the criteria for patient selection is still not clear. Through respective analysis, the investigators have set up a prediction model and wish to validate this model prospectively.

Eligibility criteria: Inclusion Criteria:

* Age ≧ 20 years
* Lung nodule size ≦2cm on the pre-operative computed tomography (CT)
* Nodulectomy is performed under thoracoscopy

Exclusion Criteria:

* Age \< 20 years
* Lung nodule size \> 2cm on CT or in the final pathology report
* Open surgery for nodulectomy

Primary outcomes:
measure: Nodule detection
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-DA Hospital
Study officials:
affiliation: E-DA Hospital
name: Ming-Wei Kao, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04004390: Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin
Official title: Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin: a Retrospective Study of Efficacy on Clinical and Isokinetic Criteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Poliomyélitis Syndrom
Keywords: Pre- and post-therapeutic evaluation carried out
Data transcribed in the computerized patient file
post-poliomyelitis syndrome
Intravenous immunoglobulins
walking test
isokinetics
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 17
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 15 men and 11 women with Diagnosis of PPS

Brief summary: Our study evaluates the efficacy of IGIV treatment in PPS on clinical (walking and pain) and isokinetic (muscle strength) criteria, on patients with PS at Montpellier's Hospital

Detailed description: Patients are admitted to a multidisciplinary consultation (neurologist, PMK) to validate the indication of treatment with IGIV. Realization of a pre-therapeutic evaluation in the department of MPR on the criteria of judgment, then the patient is admitted in a service of neurology to benefit from the cure of IGIV. The patient is then re-admitted to a PMR service for post-treatment evaluation.

Collection of data retrospectively.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PPS
* Pre- and post-therapeutic evaluation carried out
* Data transcribed in the computerized patient file

Exclusion Criteria:

* No walking patient

Primary outcomes:
measure: Muscular strength
timeFrame: 5 months
Secondary outcomes:
measure: Walking perimeter
timeFrame: 5 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: MOIZIARD Vincent, intern
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00976690: Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
Official title: A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn Disease
Keywords: Crohn's Disease
Ileocolic resection
Endoscopic recurrence
Ileocolic or colon resection (>50cm)
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 83
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: To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.


Eligibility criteria: Inclusion Criteria:

* more than 18 years old
* Clinical remission at inclusion time (CDAI\<150)
* Having ileocolonic or colon resection 21 days before inclusion
* Resection \> 50cm or subtotal colectomy with ileorectal anastomosis

Exclusion Criteria:

* Intolerance to one of both study treatment
* Liver failure (TP\<60%)
* Renal Failure (Creatinine \< Lab results)

Primary outcomes:
measure: Clinically and endoscopically recurrence at 12 and 24 months
timeFrame: 12 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Besancon
country: France
facility: Chu Besancon
city: Caen
country: France
facility: CHU CAEN
city: Clichy
country: France
facility: Hopital Beaujon
city: Lille
country: France
facility: Chru Lille
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital St Antoine
city: Paris
country: France
facility: Hopital Cochin
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Reims
country: France
facility: Chu Reims
city: Rennes
country: France
facility: Chu Rennes
city: Toulouse
country: France
facility: Chu Toulouse
city: Tours
country: France
facility: Chu Tours
Study officials:
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Marc LEMANN, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: