louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02940457: Cognitive Ability Training for Seniors With Mild Cognitive Impairment
Official title: Verbesserung Kognitiver Fähigkeiten Bei Personen Mit Verdacht Auf Eine Leichte Kognitive Beeinträchtigung
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: tDCS
MCI
Working Memory
fNIRS
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation \[tDCS\]) during working memory training in seniors with mild cognitive impairments.The placebo-controlled double blinded study includes 50 elderly patients which will be randomized into verum or sham tDCS.

Detailed description: In this project, we want to test whether the effectiveness of neuropsychological exercise therapy can be increased in elderly persons suspected of having an MCI by means of parallel tDCS treatment.

All test participants train over 6 sessions within 2 weeks two different working memory tasks with increasing difficulty. In the randomized, double-blind, prospective therapy study, participants are assigned to either a Verum-tDCS or a placebo-tDCS group. The Verum-tDCS group receives active stimulation in parallel to the exercise therapy, while the placebo group does not receive tDCS stimulation. To check the effects of the therapy, we measure performance and neuronal activation in different executive tasks using near-infrared spectroscopy (NIRS). Furthermore, we will check whether the training increases the volume of the grey matter (Draganski et al., 2004, Malchow et al., 2016) and the expression of BDNF can be increased (Schuch et al., 2015).

Eligibility criteria: Inclusion Criteria:

* suspected MCI
* total CERAD score \<= 85.1
* MMSE \>=24
* native german speaker
* between 50-75 years old
* right handed

Exclusion Criteria:

* impairment of daily living activities
* psychiatric, neurological diseases
* uncorrected hearing or vision deficits
* actual psychopharmaca intake
* metal parts in the head
* medical electronical implants

Primary outcomes:
measure: Brain activation measured with NIRS
timeFrame: 4 weeks
measure: Reaction times, errors and number of generated words in neuropsychological tasks
timeFrame: 4 weeks
Secondary outcomes:
measure: T1 weighted magnetic resonance Imaging (MRI) of the brain
timeFrame: 4 weeks
measure: Blood sampling
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital
Study officials:
affiliation: Wuerzburg University Hospital
name: Martin Herrmann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675557: Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney Disease Patients on Chronic Hemodialysis
Official title: Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
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 compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney Disease subjects requiring chronic hemodialysis.

Detailed description: This is a randomized, single blind, controlled study. Subjects will be randomly assigned to receive 1) placebo capsules (control group); 2) capsules with ergocalciferol (the vitamin D2 group); or 3) capsules with cholecalciferol (the vitamin D3 group).

Eligibility criteria: Inclusion Criteria:

* 30 men and women, ages 20-65, BMI 18-30, requiring chronic hemodialysis

Exclusion Criteria:

* They will habitually consume less than 16 oz of milk per day and get less than 10 hours of sun exposure per week. We will exclude those with granulomatous conditions, cirrhotic liver disease, and those taking anticonvulsants, barbiturates, or steroids in any form or any investigational drugs within 4 weeks. We will exclude those with pregnancy or planned pregnancy, hypercalcemia (\>10.4 mg/dl) previously recorded, chronic GI disease which would interfere with absorption, any allergy to vitamin D3, or chronic vitamin D intake \>1,000 IU daily. Subjects will continue to take a calcitriol analogue and phosphorus binder as prescribed by their nephrologist. Calcitriol analogues are to be documented and remain constant throughout study.

Primary outcomes:
measure: 25(OH)D
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Laura AG Armas, MD,MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graeff-Armas LA, Kaufmann M, Lyden E, Jones G. Serum 24,25-dihydroxyvitamin D3 response to native vitamin D2 and D3 Supplementation in patients with chronic kidney disease on hemodialysis. Clin Nutr. 2018 Jun;37(3):1041-1045. doi: 10.1016/j.clnu.2017.04.020. Epub 2017 Apr 30.
Clinical trial NCT01978457: Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction
Official title: Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cocaine Dependent Subjects
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: We will develop a procedure for conditioning cue-cocaine associations in human drug users. Next, we will reactivate that learning and intervene pharmacologically to prevent the reconsolidation of cue-drug memories. We hypothesize that a combined behavioral and pharmacological approach will have significant potential for persistently inhibiting relapse.


Eligibility criteria: Inclusion Criteria:

1. Age 18 - 50 years
2. voluntary, written, informed consent
3. physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
4. DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
5. recent street cocaine use in excess of that administered in the current study
6. intravenous and/or smoked (crack/freebase) use
7. positive urine toxicology screen for cocaine
8. for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (-HCG) test
9. able to read English and complete study evaluations.

Exclusion Criteria:

1. Other drug dependence (except nicotine)
2. a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine
3. a history of significant medical (cardiovascular) or neurological illness (e.g., prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrythmias of clinical significance, and/or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures)
4. current use of psychotropic and/or potentially psychoactive prescription medication
5. seeking treatment for drug abuse/dependence
6. those having contraindications to beta-blocker administration, including diagnoses of asthma, bronchitis, emphysema, or a history of adverse reactions to beta-blockers (including propranolol), as well as those with bradycardia and/or first-degree or greater heart block by ECG

Primary outcomes:
measure: Total number of patient controlled analgesic (PCA) pump activations (responses)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
References:
Clinical trial NCT04727957: Predictive Analytics in Lower Respiratory Tract Infections (VA-LRTIs)
Official title: Predictive Analytics in Ventilator-Associated Events
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator-Associated Event
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 30000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult mixed medical-surgical ICU patients

Brief summary: To determine the accuracy and generalizability of VA-LRTI algorithm to detect and predict three high-incidence and high-impact VAEs from electronic health records data: 1) ventilator-associated event, 2) ventilator-associated pneumonia, and 3) ventilator-associated tracheobronchitis.


Eligibility criteria: All invasively ventilated ICU patient (aged 18 or over)

Primary outcomes:
measure: Number of participants with VA-LRTI as assessed by risk-calculator
timeFrame: 1.6.-31.12.2021
Secondary outcomes:
measure: Rate of in-hospital mortality
timeFrame: 1.6.-31.12.2021
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Univeristy of Oulu
Study officials:
References:
Clinical trial NCT01159457: Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients
Official title: Engerix B Versus Sci-B-Vac Immunization in a Celiac Population of Non-responders to Primary Hepatitis B Immunization Series - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Celiac Disease
Keywords: Celiac Disease
Hepatitis B vaccination
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 210
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Celiac disease and infection with hepatitis B virus (HBV) are very prevalent worldwide and carry a high morbidity rate. It has been recently shown that patients with celiac disease very often fail to develop immunity after standard vaccination for HBV during infancy. In this study, we will evaluate whether a second vaccination series with a different vaccine, Sci-B-Vac, results in a better immunological response in celiac patients. Eligible patients will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac vaccines.. Rate of responders and level of immunity will be compared. This study will facilitate better protection of celiac patients to this potentially deadly virus.


Eligibility criteria: Inclusion Criteria:

* Patients above 1 year of age with confirmed diagnosis of celiac disease by characteristic symptoms, serology and small bowel biopsy.
* Completion of the IM HBV vaccine series in infancy.
* HBsAb titer of \<10mIU/mL at the time of enrollment.

Exclusion Criteria:

* Immunocompromised subjects or those receiving medications that may modulate or suppress the immune system (i.e. azathioprine, 6-MP, steroids).
* Inability to obtain written informed consent and patients' assent, as appropriate by the maturity age.

Primary outcomes:
measure: Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group
timeFrame: two years
Secondary outcomes:
measure: Rate of responders four weeks after the completion of the series
timeFrame: two years
measure: Rate and characteristics of adverse drug reactions
timeFrame: two years
measure: Numerical increase in the antibodies titer before and after vaccination
timeFrame: two years
measure: Rate of responders in the cross over phase.
timeFrame: two years
measure: Association between the HBsAg-specific cytokine secreting PBMCs by the ELISPOT assay and vaccine response
timeFrame: two years
measure: Association between genetic make-up and vaccine response
timeFrame: two years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: SZMC
Study officials:
affiliation: Shaheed Ziaur Rahman Medical College
name: Lena Rachman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05665257: Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases
Official title: Preoperative Inspiratory Muscle Training for Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Metastases
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this randomized controlled feasibility study was to evaluate the feasibility of preoperative inspiratory muscle training in patients undergoing surgery because of peritoneal metastases.

The main questions it aimed to answer was how feasible the intervention is regarding process and scientific feasibility as defined by Thabane et al 2010.

Participants in the intervention group were using a handheld device to increase their inspiratory muscle strength prior to surgery and researchers compared this group to a control group who were offered a sham treatment.


Eligibility criteria: Inclusion Criteria:

* Scheduled for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

* Surgery scheduled less than two weeks from the date of inclusion
* Inability to speak and understand Swedish

Primary outcomes:
measure: Feasibility of preoperative inspiratory muscle training
timeFrame: The different outcome measures are assessed continuously during a period from inclusion until discharge from the hospital. This period varied in length (3 weeks-3 months) depending on when participants were scheduled for surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medical Sciences, Respiratory, Allergy and Sleep Research, Uppsala University
name: Mikael Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00558857: Dynamic Substrate Mapping (DSM) for Ischemic VT
Official title: Clinical Feasibility of Using Dynamic Substrate Mapping to Guide Ablation of Ischemic Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ischemic Ventricular Tachycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-11-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, non-randomized study to determine the feasibility of using a new technique called Dynamic Substrate Mapping (DSM) to help guide the treatment of ischemic ventricular tachycardia (IVT). We hypothesize that DSM will lead to simpler, more effective ablation of IVT. Results from this study will be used to determine if further clinical investigation is warranted.


Eligibility criteria: Inclusion Criteria:

* Have an ICD or CRT-D device
* Had at least 3 documented device therapies to treat VT over last 3 months
* Clinical VT is confirmed or suspected to be of ischemic origin
* Scheduled for VT ablation procedure
* LVEF \> or = 20%

Exclusion Criteria:

* Inadequate AAD washout (amiodarone should be maintained at current dose)
* Unstable angina
* Active ischemia
* Cardiac surgery within prior 2 months
* Evidence of infection
* Prosthetic mitral or aortic valve or mitral/aortic valvular heart disease requiring surgical intervention
* History of embolic event
* Myocardial infarction within prior 6 weeks
* Enrolled in another study
* Recurrent sepsis or otherwise not a candidate for catheterization
* Hypercoagulable state or inability to tolerate heparin therapy during procedure
* Has had an atriotomy or ventriculotomy within prior 4 months
* Life expectancy \< 6 months
* Class IV NYHA classification

Primary outcomes:
measure: Incidence of serious adverse events (SAEs)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Philadelphia
country: United States
facility: Hospital at the University of Pennsylvania
state: Pennsylvania
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
affiliation: University of Pennsylvania
name: David Callans, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Jason Jacobson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02952157: Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff
Official title: Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sore Throat
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. The investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Patients scheduled for general anesthesia with endotracheal intubation
* Patients scheduled for surgery which duration is expected to less than 3 hr

Exclusion Criteria:

* Difficult airway
* Rapid sequence induction
* Recent sore throat
* Recent upper respiratory infection
* Asthma
* Chronic obstructive pulmonary disease
* Chronic cough
* Pregnancy
* Allergy to lidocaine
* Friable teeth
* History of head and neck surgery
* Multiple intubation attempts
* Regional anesthetic agents
* Gastric tube
* Dexamethasone

Primary outcomes:
measure: Number of participants with sore throat
timeFrame: At 24 hr
Secondary outcomes:
measure: Number of participants with sore throat
timeFrame: At 1, 6, and 12 hr
measure: Number of participants with hoarseness
timeFrame: At 1, 6, 12 and 24 hr
measure: Number of participants with throat numbness
timeFrame: At 1, 6, 12 and 24 hr
measure: Number of participants with nausea
timeFrame: At 1, 6, 12 and 24 hr
measure: Number of participants with vomiting
timeFrame: At 1, 6, 12 and 24 hr
measure: Number of participants with cough
timeFrame: At 1, 6, 12 and 24 hr
measure: Number of participants with dry mouth
timeFrame: At 1, 6, 12 and 24 hr
measure: Number of participants with additional pain medication
timeFrame: At 24 hr
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02306057: Fluid Balance in Children Undergoing Fontan Surgery
Official title: Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Defects, Congenital
Hypoplastic Left Heart Syndrome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2014-12-03
Enrollment: 39
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with congenital heart defect scheduled for Fontan surgery

Brief summary: This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the child end up with a univentricular heart with one-chamber circulation ( Fontan circulation). This project will evaluate if these children has increased micro vascular leakage before surgery due to their congenital heart defect. The project will also investigate if the edema formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and hypothermia is caused by capillary leakage of plasma protein.

The study hypothesis are

1. Edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane.
2. The degree of micro vascular leakage in open-heart surgery is related to duration of CPB and hypothermia.
3. Fontan circulation cause peripheral edema related to elevated central venous pressure and is not caused by increased micro vascular leakage of plasma proteins.


Eligibility criteria: Inclusion Criteria: Diagnosis of Congenital heart defect in need of Fontan procedure -

Exclusion Criteria: No parental consent

-

Primary outcomes:
measure: Interstitial colloid osmotic pressure
timeFrame: Before and after surgery or catheterization
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Marianne Indrebø, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Indrebo M, Berg A, Holmstrom H, Seem E, Guthe HJT, Wiig H, Norgard G. Fluid accumulation in the staged Fontan procedure: the impact of colloid osmotic pressures. Interact Cardiovasc Thorac Surg. 2019 Apr 1;28(4):510-517. doi: 10.1093/icvts/ivy298.