louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05688826: The Effect of Sugar Load in IBS Patients Depending on Sucrase-isomaltase Genes
Official title: Comparison of Sugar Load Between Normal and Functional Variants of Sucrase-isomaltase Genes in IBS
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sucrase-Isomaltase Deficiency
Irritable Bowel Syndrome
Keywords: gastrointestinal symptoms, glucose
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 100
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
Intervention model description: Patients with normal genes and with functional variants of sucrase-isomaltase genes
Primary purpose: DIAGNOSTIC

Brief summary: The investigators know that many patients with irritable bowel syndrome (IBS) have functional variants of genes coding for sucrase-isomaltase enzymes. The investigators will now examine whether these functional variants are associated with defect degradation of sucrose and associated gastrointestinal symptoms

Detailed description: The investigators have in a previous study included IBS patients for treatment with a starch- and sucrose reduced diet (SSRD). The investigators found a great improvement of symptoms. The investigators gene-tested those patients, and now have the full identification of all functional variants encoding sucrase-isomaltase enzymes.

The investigators will invite patients from this previous study with normal genes and functional variants of genes. The patients will come fasting over night to the department of clinical research. The participants will ingest 75 g sugar dissolved in 0.8 dl water and flavored with lemon, to ingest during 5 minutes. After that, glucose will determined repeatedly up to 2 hours afterwards. At the same time, the participants have to assess their gastrointestinal sympotms on visual analogue scales (VAS).

The investigators will compare the raise in b-glucose and symptoms between the groups of patients, divided into gene expression.

Eligibility criteria: Inclusion Criteria:

* Participants of our previous clinical trial with SSRD diet (NCT03306381)

Exclusion Criteria:

* Difficulties in taking blood samples

Primary outcomes:
measure: Changes from baseline of blood glucose levels
timeFrame: From distribution repeatedly up to 2 hours
measure: Change from baseline of gastrointestinal symptoms
timeFrame: From baseline and up to 2 hours, at the same time points as blood glucose is measured
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of Internal Medicine, Skåne University Hospital
Study officials:
affiliation: Department of Internal Medicine, Skåne University Hospital, Malmö
name: Cecilia Kennback, Nurse
role: STUDY_DIRECTOR
References:
Clinical trial NCT01445626: A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-10-04
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received at least 2 injections of OZURDEX® to treat macular oedema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in at least 1 eye.

Brief summary: This study will use retrospective data to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular oedema due to Retinal Vein Occlusion (RVO).


Eligibility criteria: Inclusion Criteria:

* Macular oedema in the study eye due to BRVO or CRVO
* Received at least 2 OZURDEX® injections in the study eye

Exclusion Criteria:

* Received OZURDEX® injections as part of or during any clinical study

Primary outcomes:
measure: Time to OZURDEX® Re-injection
timeFrame: Up to 12 months
Secondary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection
timeFrame: Baseline, 7 to 12 weeks following the last injection
measure: Percentage of Patients With an Increase of 2 Lines or More in BCVA
timeFrame: Baseline, Up to 12 months
measure: Percentage of Patients With an Increase of 3 Lines or More in BCVA
timeFrame: Baseline, Up to 12 months
measure: Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection
timeFrame: Baseline, 7 to 12 weeks following the last injection
measure: Time to Improvement of 2 Lines or More in BCVA
timeFrame: Baseline, Up to 12 months
measure: Time to Improvement of 3 Lines or More in BCVA
timeFrame: Baseline, Up to 12 months
Other outcomes:
Locations:
city: Muenster
country: Germany
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02280226: Evaluating the Influence of Apnea on Cardiac Function Using Cardiac Magnetic Resonance Imaging.
Official title: Evaluating the Influence of Apnea on Heart Function With Strain Analysis and Measurement of Fibrosis Derived From T1-mapping Using Cardiac Magnetic Resonance Imaging (MRI).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Changes in Deliberate Apnea
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Former studies revealed a distinct pattern of changes in circulation during deliberate apnea. Blood pressure rises significantly often accompanied by bradycardia. Further studies confirmed a massive increase of total vascular resistance as it also happens in shock to maintain perfusion of heart, lung and brain. This study is to determine the exact alterations of the cardiac function during this reaction, show the redistribution of blood volume in apnea and evaluate possible longterm effects on the central nervous system caused by repeated apnea via magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

* Being able to hold breath deliberately at least 4,5 minutes

Exclusion Criteria:

-

Primary outcomes:
measure: Cardiac Function: Duration of Apnea
timeFrame: every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements
measure: Mean Blood Flow Measurement Under Apnea Using MRI
timeFrame: Every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Eichhorn L, Doerner J, Luetkens JA, Lunkenheimer JM, Dolscheid-Pommerich RC, Erdfelder F, Fimmers R, Nadal J, Stoffel-Wagner B, Schild HH, Hoeft A, Zur B, Naehle CP. Cardiovascular magnetic resonance assessment of acute cardiovascular effects of voluntary apnoea in elite divers. J Cardiovasc Magn Reson. 2018 Jun 18;20(1):40. doi: 10.1186/s12968-018-0455-x.
Clinical trial NCT04948957: Changes in Cerebral Oxygenation and Cognitive Functions
Official title: Changes in Cerebral Oxygenation and Cognitive Functions During Controlled Hypotension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension; Controlled
Cognitive Dysfunction
Keywords: cerebral oxygenation
cognitive function
esmolol
nitroglycerine
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - required controlled hypotension scheduled for nasal surgeries

Brief summary: The present study aimed to assess the influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by using near-infrared spectroscopy and postoperative cognitive function in patients undergoing nasal surgery.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* patients with ASA physical status of I-II
* aged 18-65 years

Exclusion Criteria:

* Age under 18 or above 65
* ASA \> II
* coagulation disorders
* history of cardiovascular and cerebrovascular disease
* poor Blood Pressure control
* anemia, pregnancy, addiction to opioids
* body mass index (BMI) \> 35
* intraoperative systolic BP \< 65 mmHg
* surgical duration less than 30 minutes or more than 160 minutes
* need for an intraoperative sympathomimetic drug and the use of other hypotensive drugs
* preoperative Mini-Mental State Examination (MMSE) score of 23 or less.

Primary outcomes:
measure: effects of controlled hypotension on cerebral oxygen saturation
timeFrame: until end of the surgical procedure.
Secondary outcomes:
measure: effects of controlled hypotension on cognitive function
timeFrame: 24 hour before surgery and 24 hour after surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References:
Clinical trial NCT01701557: Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
Official title: Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Ketoacidosis Fluids
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized trial to determine if the volume of fluid administration in pediatric patients with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of treatment

Detailed description: A randomized trial of two initial volumes of IVF and subsequent administration rates. Group I received 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance and Group II received 20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance. The specific variables measured included demographics (age, gender, and race/ethnicity) and routine laboratory values (pH, pCO2, plasma glucose, electrolytes, bicarbonate, sodium, chloride, BUN. Length of treatment was defined as a time of the hospital stay after the start of IVF infusion.

Eligibility criteria: Inclusion Criteria:

* 1 day to 18 years of age
* type 1 diabetes
* presence of DKA, as defined by glucose \>250 mg/dl, accumulation of ketone bodies in the blood, and metabolic acidosis (venous pH \< 7.30 or serum bicarbonate \< 15 mmol/L.)

Exclusion Criteria:

* requirement for additional fluid resuscitation for hemodynamic instability
* weight greater than 70 kilograms

Primary outcomes:
measure: time to normalization of bicarbonate and pH
timeFrame: start of treatment until resolution of DKA an expected average of 12 to 24 hours
Secondary outcomes:
measure: the length of treatment
timeFrame: discharge from the hospital, an expected average of 1-2 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: the Childrens Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Arleta Rewers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakes K, Haukoos JS, Deakyne SJ, Hopkins E, Easter J, McFann K, Brent A, Rewers A. Effect of Volume of Fluid Resuscitation on Metabolic Normalization in Children Presenting in Diabetic Ketoacidosis: A Randomized Controlled Trial. J Emerg Med. 2016 Apr;50(4):551-9. doi: 10.1016/j.jemermed.2015.12.003. Epub 2016 Jan 25.
Clinical trial NCT04187157: Association Between Light Spectrum and Survival After Cataract Surgery
Official title: Association Between the Implantation of Conventional or Blue Light-filtering Intraocular Lens and Survival Among Patients Undergoing Bilateral Cataract Surgery: a Multi-center, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Age-related Cataract
Circadian Rhythm Disorders
Glaucoma
Age Related Macular Degeneration
Keywords: circadian
cataracts
blue light
survival
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 10192
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of all adult patients (at least 65 years) who underwent bilateral cataract surgery between January 01, 2012 and January 01, 2018 within the University of Pittsburgh Medical Center (UPMC) healthcare system.

Brief summary: This study was a retrospective observational cohort analysis of subjects aged 65 years and older, who underwent bilateral cataract surgery within a single (15 hospital) healthcare system, to determine the association between type (conventional or blue-light filtering) of implanted intraocular lens and survival.


Eligibility criteria: Inclusion Criteria:

* The study population consisted of all adult patients (at least 65 years) who underwent bilateral cataract surgery between January 01, 2012 and January 01, 2018 within the University of Pittsburgh Medical Center (UPMC) healthcare system. To be considered bilateral and concomitant, cataract surgery had to be performed on both the left and the right eye within a 365-day period.

Exclusion Criteria:

* We excluded patients undergoing unilateral cataract surgery, surgery to replace or repair a previously implanted IOL, or bilateral implantation with one Blue-IOL and one Natural-IOL (i.e., mixed IOL transmission properties).

Primary outcomes:
measure: All-cause mortality
timeFrame: From the date of the initial cataract surgery until the date of death or end of the study period (April 30, 2019), whichever occurred first, assessed up to 2,310 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC-Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Matthew R Rosengart, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01500057: Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
Official title: An Open-Label Randomized Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: enlarged prostate
Lead sponsor: Brooklyn Urology Research Group
Sponsor class: OTHER
Collaborators: name: American Medical Systems
name: Richard Wolf Medical Instruments Corporation (RWMIC)
First posted: 2011-12-26
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.


Eligibility criteria: Inclusion Criteria:

* male over the age of 18 years
* present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention
* subjects must read, understand and sign the Informed Consent
* AUA ≥ 15
* Qmax \< 15mL/sec
* Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months
* Prostate volume ≥ 30g

Exclusion Criteria:

* PVR \> 300ml
* Current urine retention
* Previous surgical or invasive treatments (TURP, TUMT, TUNA)
* PSA ≥ 4 (must have negative biopsy within last 12 months)
* Neurogenic bladder
* Obstruction due to urethral stricture
* Any disorder or condition of the subject that the investigator believes will counter indicate their inclusion in the study

Primary outcomes:
measure: Change From Baseline in American Urological Association Symptom Score
timeFrame: Baseline and 12 months
measure: Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Change From Baseline to 12 Months in Post Void Residual Volume
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brooklyn Urology Research Group
state: New York
Study officials:
References:
Clinical trial NCT00714857: Population Pharmacokinetics of Dexmedetomidine in ICU Patients
Official title: Population Pharmacokinetics of Dexmedetomidine in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pharmacokinetics
Keywords: ICU patients
Dexmedetomidine
Sedation
Judged
Attending
Physician
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Dexmedetomidine is a new, highly selective and potent alpha2-adrenoreceptor agonist registered for sedation of patients in intensive care units. Although the pharmacokinetics of dexmedetomidine have been studied previously also in an ICU setting, there is no information on the pharmacokinetics of long-lasting (\>48 hours) dexmedetomidine infusions in humans.

The aim of this study is to study the pharmacokinetics of long-lasting dexmedetomidine infusions in ICU patients using the population pharmacokinetics approach.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Need for dexmedetomidine sedation (determined by the responsible physician).
* Predicted length of dexmedetomidine sedation ≥ 48 hours.
* Written informed consent from the patient or the relatives of the participating patient.

Exclusion Criteria:

* A previous history of intolerance to the study drug or related compounds and additives.
* Existing significant haematological, endocrine, metabolic or gastrointestinal disease

Primary outcomes:
measure: Pharmacokinetic parameters
timeFrame: Blood samples are taken three times daily for characterizing the pharmacokinetic parameters
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Timo T Iirola, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04235257: Intradermal, Fractional Dose of HPV Vaccines:
Official title: Immunogenicity of Fractional Dose of the Bivalent and Nonavalent Intradermal HPV Vaccines.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: HPV Infection
HPV Vaccine
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 40
Sex: ALL
Minimum age (years): 27
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized phase IV trial compares fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, 12 months, and 24 months.


Eligibility criteria: Inclusion Criteria:

* Age 27-45 years at enrollment
* Not intending to receive the HPV vaccine series for the duration of the study participation
* Willing and able to provide written informed consent, undergo clinical evaluation, and adhere to follow-up schedule

Exclusion Criteria:

* Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
* Currently pregnant or breastfeeding
* Immune deficiency or other immune disorder
* HIV infection or continued high risk for HIV; patients at risk for HIV who do not have a negative HIV test in the last 6 months will be excluded
* Cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer)
* Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes,
* Known allergy to vaccine components
* Prior history of HPV-associated cancer

Primary outcomes:
measure: HPV antibody detection after fractional HPV vaccination
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Virology Research Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Anna Wald, MD
role: PRINCIPAL_INVESTIGATOR
References: