louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04373304: The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients
Official title: The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
FODMAP
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tertiary care IBS patients will be recruited for a prospective low FODMAP intervention study, hereby focusing on the reintroduction phase of the diet, where patients are blindly challenged with different FODMAP groups administered as powder, to be added to the strict FODMAP exclusion phase. During the screening phase of two weeks, baseline data regarding psychological, nutritional, microbial, and genetics will be collected. Predictors of treatment response (a 50-point drop on the IBS-severity scoring system (IBS-SSS) during the strict FODMAP exclusion phase of 6 weeks) will be studied with linear mixed models.


Eligibility criteria: Inclusion Criteria:

* Patients are eligible for the study if all of the following criteria are met:

  1. Patients with irritable bowel syndrome as per Rome IV diagnostic criteria
* Symptom characteristics of IBS according to Rome IV criteria 2. Patients must provide witnessed written informed consent prior to any study procedures being performed 3. Patients aged between 18 and 70 years inclusive 4. Male or female patients

Exclusion Criteria:

* Patients are excluded from the study if any of the following criteria are met:

  1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
  2. Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
  3. Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD)
  4. Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.
  5. Females who are pregnant or lactating are excluded from the study.

Primary outcomes:
measure: Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
timeFrame: approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT02974504: Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)
Official title: A Multicenter, Randomized, Double-blind, Active-contrelled, Parallel-group, Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin After Oral Administration in Patiend With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type2 Diabetes
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-28
Enrollment: 207
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, randomized, double-blind, active-controlled, parallel group, phase IV clinical trial to investigate the effect on blood glucose of evogliptin after oral administration in patients with type 2 diabetes

Detailed description: 1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-24 weeks.
2. Liniagliptin 5mg Group: Administration with linagliptin 5mg for 0-12 weeks, and with Evogliptin 5mg for 13-24 weeks

Eligibility criteria: Inclusion Criteria:

* Subjects with 7.0%≤HbA1c≤10.0% at screening

  * Subjects untreated with oral hypoglycemic agents within 8 weeks prior to screening
* Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion Criteria:

* Subjects with fasting plasma glucose≥270mg/dL at screening
* Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
* Subjects with history of myocardial infarction, cerebral infarction within 24 weeks prior to screening
* Subjects with ALT and AST 3 times or higher than upper normal range

Primary outcomes:
measure: HbA1c
timeFrame: Change from baseline at 12 week
Secondary outcomes:
measure: fasting plasma glucose
timeFrame: Change from baseline at 12 week
measure: HbA1c response rate
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
References:
Clinical trial NCT05646004: 621 Real World Study
Official title: An Open Single-arm Clinical Investigation to Evaluate the Clinical Safety and Effectiveness of 621
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Senile Cataract
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 105
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: This study is evaluating the clinical safety and effectiveness of 621, after cataract surgery.


Eligibility criteria: Inclusion:

1. Age ≥ 18 years old;
2. Patient with clinically significant cataract with planned phacoemulsification cataract extraction and implantation of IOL into the capsular bag;
3. Preoperative corneal astigmatism ≤ 1.00D;
4. Patient is willing and capable of providing informed consent;
5. Patient is willing and capable of complying with visits and procedures as defined by this protocol.

Exclusion:

1. Preoperative best corrected visual acuity \> 4.7 or ≤ 0.3 logMAR;
2. Corneal endothelial cell count less than 2000 cell/mm2;
3. Age under 18 years old;
4. Pregnant and lactating women;
5. Patients who attend other drug or medical device study;
6. Ocular disorder that could potentially cause a clinically significant future visual acuity loss;
7. Anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
8. Abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies);
9. Any condition in the study eye that could affect IOL stability (e.g. pseudo-exfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc;
10. Any acute infection (acute ocular disease, external/internal infection, systemic infection);
11. History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, microphthalmia, aniridia, epiretinal membrane etc.) in the study eye that could alter or limit final postoperative visual prognosis;
12. Any previous intraocular and corneal surgery ;
13. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
14. Current systemic or ocular pharmacotherapy that effects patients' vision;
15. Current pathology or condition that could be a risk for the patient according to the investigator opinion;
16. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the clinical investigation;
17. Patients whose freedom is impaired by administrative or legal order.

Primary outcomes:
measure: Corrected Distance Visual Acuity (CDVA)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qionghai
country: China
facility: Hainan Boao Lecheng Aier Eye Hospital
state: Hainan
Study officials:
References:
Clinical trial NCT05235204: Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair
Official title: Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colovesical Fistula
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 48
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: Patients undergoing surgical repair of colovesical fistula will have have "early" (post-operative day 3) cystogram and removal of bladder catheter. Outcomes from the "early" group will be compared to historical "late" group data to determine if early bladder catheter removal is safe.

Detailed description: There is defined time for foley/bladder catheter removal after colovesical fistula repair in the current surgical literature. This study will be a prospective cohort study evaluating outcomes after early foley catheter removal (on post-operative day 3), specifically bladder leak, 30-day readmissions and adverse events. This cohort will be compared to a retrospective "late" group, who had foley catheter removal later in their hospital course.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and over
* Undergoing surgical repair of diverticular colovesical fistula

Exclusion Criteria:

* Patients with active and untreated genitourinary cancers
* Subjects with known or suspected Inflammatory Bowel Disease as the cause of colovesical fistula.
* Individuals who are not expected to regain normal bladder function after surgery as defined by either pre-existing bladder dysfunction with chronic indwelling urinary catheter, supra-pubic catheter, or surgical urinary diversion
* Individuals who require re-operation prior to Foley removal
* Adults unable to consent
* Pregnant women
* Prisoners
* Individuals who are not yet adults (infants, children, teenagers less than 18 years old)

Primary outcomes:
measure: Presence of positive urine leak on post-operative day 3 cystogram
timeFrame: up to 3 days post surgery
Secondary outcomes:
measure: Foley catheter re-insertion
timeFrame: up to 5 days post-surgery
measure: Re-operations within 30 days of initial surgery
timeFrame: up to 30 days post discharge
measure: Hospital re-admission
timeFrame: up to 30 days post- discharge
measure: Symptomatic post-operative urinary tract infection
timeFrame: up to days post discharge
measure: Post operative urinary sepsis
timeFrame: up to 30 days post discharge
measure: Recurrence of colovesical fistula
timeFrame: up to 30 days post-discharge
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center Memorial Campus
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: KArin Alavi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06416904: Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper Versus Mini-Screws
Official title: Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper in Comparison to Mini-Screws in Post-Pubertal Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 26
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare the anchorage control during canine retraction using arch wire stopper versus mini-screws in post-pubertal patients with maxillary dentoalveolar protrusion

Detailed description: The study begins with patient selection according to inclusion and exclusion criteria, followed by treatment planning, and then bonding of orthodontic brackets of the upper and lower arches, including the second maxillary molars.

After leveling and alignment for all participants, the extraction of the maxillary first premolars will be performed.

* In the "Intervention Group" Canine retraction will be performed on 0.017×0.025 ss archwire with an archwire stopper mesial to the upper first molar.
* In the "Comparator Group" Canine retraction on 0.017×0.025 ss archwire with the upper first molars indirectly anchored to inter-radicular mini screws

Lastly, the anchorage control in both groups and the secondary outcomes will be assessed using the obtained digital models and lateral cephalometric radiographs.

Eligibility criteria: Inclusion Criteria:

* Post-pubertal female patients.
* Cases with bimaxillary protrusion or Class II Division 1 malocclusion that require maxillary first premolars extraction.
* Full permanent dentition (not necessitating third molars).
* Good oral hygiene.

Exclusion Criteria:

* Medically compromised patients.
* Active periodontal disease or obvious bone loss in the maxillary arch.
* Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
* Smoking or any systemic diseases.
* Chronic use of any medications including antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers. All the above factors affect the rate of tooth movement
* Previous orthodontic treatment.
* Missing teeth.

Primary outcomes:
measure: Amount of anchorage loss of the maxillary first molars
timeFrame: 6 months from the start of the canine retraction
Secondary outcomes:
measure: Tipping of the maxillary first molar.
timeFrame: 6 months from the start of the canine retraction
measure: Maxillary incisors inclination
timeFrame: 6 months from the start of the canine retraction
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Cairo University
name: Mennatallah Ali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04167904: Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction
Official title: Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction, Acute
Keywords: Troponin I
Myocardial Infarction
Sensitivity and Specificity
Receiver operation characteristics curve
Biomarkers
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2019-11-19
Enrollment: 4446
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: Patients admitted to St. Olavs Hospital (Trondheim University Hospital) with suspected acute myocardial infarction without ST-elevations on ECG (NSTEMI).

Brief summary: The concentration of troponins in plasma is used for diagnosing acute myocardial infarction. Different types of heart-specific troponins can be measured and with different analytical methods. The primary aim of this study is to evaluate the diagnostic characteristics of a new analytical method for measuring troponin I in diagnosing acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* hospitalized at St. Olavs hospital
* blood sampled for troponin analysis due to suspicion of acute myocardial infarction without ST-elevations on ECG less than 4 hours after admitted to the hospital

Exclusion Criteria:

* residency outside Norway
* does not understand Norwegian

Primary outcomes:
measure: Acute myocardial infarction according to the 4th universal definition of myocardial infarction
timeFrame: Before discharge from hospital, a median of 2 days
Secondary outcomes:
measure: Days between hospital discharge and death
timeFrame: Within 30 days after hospital discharge
measure: Days between hospital discharge and acute myocardial infarction according to the 4th universal definition of myocardial infarction
timeFrame: Within 30 days after hospital discharge
measure: Days between hospital discharge and coronary revascularization
timeFrame: Within 30 days after hospital discharge
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs hospital
Study officials:
affiliation: St. Olavs Hospital
name: Gustav Mikkelsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04864301: Tumescent Stretching Measurement Technique
Official title: Tumescent Stretching Measurment Technique: A New Technique for Intraoperartive Measurement of Inflatable Penile Implant Size
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: To Try to Eliminate Frequencies of Insertions in Order to Arrive to Adequate Size of Implanted Penile Prosthesis
Keywords: penile implant, iflatable penile implant, re-insertion, measurement
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 24
Sex: MALE
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introducing and evaluating the accuracy of a novel method for estimating inflatable penile prosthesis cylinders length by stretching the tumesncent penis intraoperatively instead of taking proximla and distal measurement to the corporotomy

Detailed description: Objectives:

Introducing and evaluating the accuracy of a novel method for estimating inflatable penile prosthesis cylinders length.

Methods:

24 patients undergoing a Coloplast Titan ® Touch implantation procedure will berandomly divided into two groups.

The "Tumescent Stretching Measurement Technique" (TSMT) group (N=12) will be administered an intracorporal injection (ICI) of 20 microgram Alprostadil. Hegar 7 dilator will be introduced through the corporotomy until reaching a bone stopping point. The tumescent penis will be stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus.

The control group (N=12) will receive no intraoperative ICI. Following maximal corporal dilatation, cylinder length will be estimated by adding up the internally measured distal and proximal corpora to the length of the corporotomy.

Implants are deemed correctly sized when cylinders reached the proximal third of the glans with no buckling of cylinders or floppy glans.

Eligibility criteria: Inclusion Criteria:

Males needing Penile implant surgery, not responding to oral pharmacological drugs for ttt of ED -

Exclusion Criteria:

Previouys penile surgery Previous implanted penile prosthesis

-

Primary outcomes:
measure: Number of penile implant insertions and re-insertions needed to arrive to adequate penile implant size
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01926301: Cerebrovascular Autoregulation in Sepsis, Influence of Renal Replacement Therapy
Official title: Cerebrovascular Autoregulation in Patients With Severe Sepsis and Septic Shock, Influence of Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Severe Sepsis
Septic Shock
Keywords: sepsis
cerebrovascular autoregulation
delirium
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe sepsis or septic shock at the intensive care unit of an university general hospital

Brief summary: The cerebrovascular autoregulation is impaired in patients with severe sepsis and septic shock. A continuous veno-venous hemodialysis may improve impaired cerebrovascular autoregulation.

Hypothesis: continuous hemodialysis recovers impaired cerebrovascular autoregulation in patients with acute severe sepsis and septic shock.


Eligibility criteria: Inclusion Criteria:

* severe sepsis or septic shock
* adult patients
* possibility of transcranial Doppler ultrasound

Exclusion Criteria:

* traumatic brain injury
* known cerebrovascular diseases
* Infection of the brain
* chronic renal failure
* pregnancy

Primary outcomes:
measure: Cerebrovascular autoregulation
timeFrame: during the first 4 days
Secondary outcomes:
measure: Delirium
timeFrame: at day 4
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg-Univerity
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Patrick Schramm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00764101: Attentional Bias Modification in Patients With Posttraumatic Stress Disorder
Official title: Effects of Attentional Bias Modification on Attentional Bias and Symptoms of Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
Lead sponsor: PsyQ
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2008-10-01
Enrollment: 80
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: Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training on attentional bias and on symptoms of Posttraumatic Stress Disorder.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Posttraumatic Stress Disorder

Exclusion Criteria:

* Diagnosis of psychosis, drug- or alcohol dependency/abuse;
* Unable to fill in questionnaires in Dutch;
* Color blindness (Stroop test).

Primary outcomes:
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: End of Trial + 3 week Follow-Up
Secondary outcomes:
measure: PTSD symptoms (self-report)
timeFrame: end of trial + 3wk Follow Up
measure: Attentional Bias (dot-probe test)
timeFrame: End of trial + 3wk Follow-up
measure: Emotional Stroop Interference
timeFrame: End of trial + 3wk Follow Up
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: PsyQ Haaglanden, department of psychotrauma
state: Zuid Holland
Study officials:
affiliation: Leiden University
name: Willem van der Does, professor
role: STUDY_DIRECTOR
affiliation: PsyQ Nederland bv
name: Maartje Schoorl, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schoorl M, Putman P, Van Der Does W. Attentional bias modification in posttraumatic stress disorder: a randomized controlled trial. Psychother Psychosom. 2013;82(2):99-105. doi: 10.1159/000341920. Epub 2012 Dec 22.