louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01237834: Physiological Responses in Tobacco Chippers
Official title: Physiological Responses in Tobacco Chippers (Non Nicotine-dependent Light Smokers)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Stress
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 178
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

Brief summary: This study will analyze a series of biological and behavioral markers in different populations of smokers. The study groups will differ in their cigarette consumption and level of nicotine dependence. This analysis will help to identify factors that might be important for smoking behavior and nicotine addiction. The results from this study will contribute to improve campaigns for smoking prevention and treatments for smoking cessation.


Eligibility criteria: Inclusion Criteria:

* healthy adults
* age 25-55

Exclusion Criteria:

* alcohol or drug addiction
* unstable significant medical problems
* neurologic disease
* medications known to affect CNS function or impact physiologic parameters measured in the study
* significant visual impairment
* breath carbon monoxide (BCO) level of less than 10 ppm for smokers
* breath carbon monoxide (BCO) level of more than 5 ppm for non-smokers
* for heavy regular smokers: erratic smoking history (i.e. they must have smoked an average of 15 cigarettes daily for at least one year)

Primary outcomes:
measure: Electroencephalography
timeFrame: Changes from baseline during a hard cognitive task
Secondary outcomes:
measure: Salivary cortisol
timeFrame: Changes from baseline during performance on a hard cognitive task
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Barry Oken
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Laura Carim Todd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00032734: Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Syndrome of Inappropriate ADH (SIADH) Secretion
Hyponatremia
Keywords: Low Blood Sodium (Hyponatremia)
SIADH
Inappropriate ADH Syndrome
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2002-04-01
Enrollment: 35
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 study is designed to assess the efficacy of an investigational drug called SR121463B (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).

This double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.

Detailed description: This is a multicenter worldwide study with 32 participating men and women aimed to figure out whether SR121463B is safe and effective in correcting low levels of sodium in blood in subjects with SIADH. The participation in the study lasts up to 34 days. After screening, during the first part of the study (maximum 5 days), the subjects receive either capsules of SR121463B or a matching placebo. During the second part of the study (23 days), subjects receive either capsules of SR121463B or no treatment. The subjects will be assessed by physical examinations, electrocardiograms, blood samplings, and urine collections. Women of childbearing potential must have an approved method of contraception.

Eligibility criteria: SIADH of any origin

Primary outcomes:
measure: serum sodium concentration
Secondary outcomes:
measure: safety assessment
Other outcomes:
Locations:
city: Diegem
country: Belgium
facility: Sanofi-aventis Administrative Office
city: Paris
country: France
facility: Sanofi-aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04753034: Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
Official title: A Multicenter, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of TER-101 Topical Ointment to Assess Efficacy and Safety in Subjects With Mild to Moderate Atopic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Teres Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-12
Enrollment: 63
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Adolescent or adult subject aged 12 - 65 years.
* Overall IGA score of 2 (mild) or 3 (moderate) at baseline on a 5-point IGA

Exclusion Criteria:

* AD with known hypersensitivity to excipients of TER-101 Ointment
* Subjects who are immunocompromised

Primary outcomes:
measure: Percent Change in EASI From Baseline at Day 29
timeFrame: 29 days
Secondary outcomes:
measure: Changes in EASI Over Time
timeFrame: 15 days
measure: Change in IGA From Baseline Over Time
timeFrame: 29 Days
measure: Changes in Itch Over Time
timeFrame: 29 days
measure: Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
timeFrame: 29 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Teres Bio site 05
state: Arizona
city: Encinitas
country: United States
facility: Teres Bio Site 04
state: California
city: North Miami Beach
country: United States
facility: Teres Bio Site 12
state: Florida
city: Tampa
country: United States
facility: Teres Bio Site 10
state: Florida
city: Clarksville
country: United States
facility: Teres Bio Site 02
state: Indiana
city: Louisville
country: United States
facility: Teres Bio Site 01
state: Kentucky
city: Saint Joseph
country: United States
facility: Teres Bio site 09
state: Missouri
city: High Point
country: United States
facility: Teres Bio Site 08
state: North Carolina
city: Wilmington
country: United States
facility: Teres Bio Site 11
state: North Carolina
city: College Station
country: United States
facility: Teres Bio Site 03
state: Texas
city: Pflugerville
country: United States
facility: Teres Bio Site 06
state: Texas
city: San Antonio
country: United States
facility: Teres Bio Site 07
state: Texas
Study officials:
References:
Clinical trial NCT01738334: Effects Of The Mindfulness Meditation Practices On Cognition
Official title: EVALUATION OF THE EFFECTS OF THE MINDFULNESS MEDITATION PRACTICES ON COGNITION OF ADULTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Meditation
Cognition
Attention Deficit Disorder with Hyperactivity
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adults with Attention Deficit Hyperactivity Disorder (ADHD) have impairments in attentional subsystems of alerting and conflict monitoring. Mindfulness meditation may lead to an improvement of these deficits, and reduces symptoms of anxiety and depression. However, the studies that demonstrated these improvements did not use a control group, nor controlled the use of medication. In the present study the investigators will examine the effects of the mindfulness practices (same protocol of 8 weekly sessions used in the study that showed positive effects in this disorder) in the performance of adult patients and healthy people (with ADHD). Cognitive performance, mood, and the quality of life will be assessed by validated questionnaires before and after treatment/standby.


Eligibility criteria: Inclusion Criteria:

* Portuguese as their first language;
* minimum of eight years of formal education;
* normal vision or corrected to normal and normal hearing;
* no prior experience with meditation;
* patients should be taking stable doses of methylphenidate (for at least a month) for their disorder as prescribed by their doctors.

Exclusion Criteria:

* patients with neurological and psychiatric disorders such as psychosis, obsessive-compulsive disorder or Tourette's syndrome.

Primary outcomes:
measure: Evaluate the ADHD symptoms before to the meditation and after 8 weeks to the meditation.
timeFrame: change from baseline in ADHD symptoms at 8 weeks
measure: Evaluate the executive functions
timeFrame: 1 day
measure: Evaluate the mood symptoms before to the meditation and 8 weeks after to the meditation.
timeFrame: change from baseline in mood symptoms at 8 weeks.
measure: Evaluate the quality of life before to the meditation and 8 weeks after to the meditation.
timeFrame: change from baseline in quality of life at 8 weeks.
measure: Evaluate the attention before to the meditation and 8 weeks after to the meditation.
timeFrame: change from baseline in attention at 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Sabine Pompéia, Postdoctoral
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Viviane F Bueno, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02531724: Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery
Official title: Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Renal Insufficiency, Acute
Keywords: acute kidney injury
cardiac surgery
renal blood flow
levosimendan
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2015-08-24
Enrollment: 30
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: Acute kidney injury (AKI) is a common complication after cardiac surgery. Mismatch in renal oxygen demand-supply may be an important pathogenetic factor. Levosimendan has been shown to improve renal blood flow, glomerular filtration rate and renal oxygenation in healthy controls after cardiac surgery.

In order to investigate the effect of levosimendan in patients with AKI after cardiac surgery, the investigators plan a randomized placebo controlled trial. 30 patients will receive levosimendan or placebo. Renal blood flow and filtration fraction will be measured using infusion clearance technique of para-aminohippuric acid and Chromium ethylenediaminetetraacetic acid (Cr-EDTA) respectively.


Eligibility criteria: Inclusion Criteria:

* Patients in the cardiothoracic intensive care after cardiac surgery with cardiopulmonary bypass
* Acute kidney injury, defined as increase in S-creatinine 50% or 27 mol/L
* Normal S-creatinine before surgery

Exclusion Criteria:

* Ongoing treatment with inotropic drugs (not norepinephrine)
* Central venous oxygen saturation (ScvO2) \< 60% despite optimization of hematocrit and volume status
* Need of renal replacement therapy
* Ongoing bleeding
* Patient or next of kin does not consent with study participation

Primary outcomes:
measure: Renal blood flow
timeFrame: 5 Hours
measure: Glomerular filtration rate
timeFrame: 5 Hours
Secondary outcomes:
measure: Serum creatinine
timeFrame: 4 days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of thoracic anesthesia, Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska Academy, dept of clinical science
name: Sven-Erik Ricksten, Professor
role: STUDY_DIRECTOR
References:
citation: Bragadottir G, Redfors B, Ricksten SE. Effects of levosimendan on glomerular filtration rate, renal blood flow, and renal oxygenation after cardiac surgery with cardiopulmonary bypass: a randomized placebo-controlled study. Crit Care Med. 2013 Oct;41(10):2328-35. doi: 10.1097/CCM.0b013e31828e946a.
citation: Tholen M, Ricksten SE, Lannemyr L. Effects of levosimendan on renal blood flow and glomerular filtration in patients with acute kidney injury after cardiac surgery: a double blind, randomized placebo-controlled study. Crit Care. 2021 Jun 12;25(1):207. doi: 10.1186/s13054-021-03628-z.
Clinical trial NCT04303624: Understanding Family Refusal
Official title: Exploring Family vs. Individual Decision-making in Organ Donation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Death
Renal Failure
Keywords: Organ donation
Transplantation
Intensive care
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2020-03-11
Enrollment: 1007
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were a representative sample of Singapore's population, approached via door-to-door recruitment and via community eateries.

Brief summary: The investigators plan a secondary data analysis of an existing dataset to examine how individual decision-making differs from family decision-making in organ donation.


Eligibility criteria: Inclusion Criteria:

* Citizens or permanent residents of Singapore
* Above 21

Exclusion Criteria:

- Below 21

Primary outcomes:
measure: Willingness to donate
timeFrame: Single measurement (time of taking the survey)
Secondary outcomes:
measure: Confidence in family decision-making
timeFrame: Single measurement (time of taking the survey)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02796924: Treating Non-epileptic Seizures Using Magnetic Brain Stimulation
Official title: The Efficacy of Transcranial Magnetic Stimulation in the Treatment of Non-epileptic Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonepileptic Seizures
Keywords: Psychogenic Non-Epileptic Seizure
Transcranial Magnetic Stimulation
Brain Stimulation
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 10
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: The purpose of this study is to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) - a form of non-invasive brain stimulation - to decrease the frequency of psychogenic non-epileptic seizure (PNES) episodes in patients with PNES.

Detailed description: This study is an open label pilot study that aims to recruit 15 individuals with diagnosed PNES to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) to decreasing the frequency of psychogenic non-epileptic seizure (PNES) episodes. rTMS is a non-invasive method of brain stimulation that uses rapid magnetic pulses applied over the scalp to active neurons in a specified target location of the brain.

Electronic as well as paper-and-pencil questionnaires will be used to asses patient's psychiatric symptoms and functional impairment both before and after treatment to monitor symptom-changes.Treatment will consist of daily sessions of high frequency (20 Hz) rTMS applied over the right temporoparietal junction (TPJ) of the cerebral cortex. Patients will receive two sessions per day for 15 consecutive weekdays. Each session will take approximately 20 minutes to complete.

Results of the questionnaires will be analyzed to determine the effect of the treatment on PNES episodes and functional impairment. As a pilot study, this research will be used to evaluate the effect size and the feasibility of a more definitive project in the future. Both patient response and tolerability to rTMS will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Confirmed Psychogenic Non-Epileptic Seizures

Exclusion Criteria:

* Evidence of previous or comorbid epileptic seizures
* Major comorbid neurological diseases
* Currently taking medications that are known to reduce seizure-threshold
* Currently pregnant

Primary outcomes:
measure: Number of Weekly Psychogenic Non-epileptic Seizure-events
timeFrame: One week and three months post-rTMS treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba
name: Mandana Modirrousta, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05974124: Effectiveness of Ophthalmic Antiseptic Preparations
Official title: Topical Ophthalmic Antiseptics and Reduction of Ocular Surface Bacterial Load Before Cataract Surgery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antiseptics
Microbiota
Conjunctiva
Keywords: Povidone-iodine
Chlorhexidine
Preoperative
Antiseptics
Conjunctival bacterial flora
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: European School of Advanced Studies in Ophthalmology
First posted: 2023-08-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomised to instill either povidone-iodine eye drops (35 patients) or chlorhexidine (35 patients) in the eye to be operated on. The contralateral eye was considered as control and received no antiseptic prophylaxis.
Primary purpose: PREVENTION

Brief summary: The aim of this clinical trial is to evaluate the effectiveness of two topical antiseptics, povidone-iodine (PVI) and chlorhexidine (CHX), in reducing conjunctival bacterial flora.

Detailed description: 70 patients undergoing cataract surgery were enrolled and randomly divided in two arms: 35 patients used PVI 0.66% 4 times daily starting 3 days before surgery; 35 patients used CHX 0.02% with the same posology. The contralateral eye was considered as control. Conjunctival swabs were collected in both eyes at the baseline (T0) and after three days of treatment (T1) all before cataract surgery. Conjunctival bacterial load has been evaluated through a molecular based method at T0 and T1 and compared to the control eye.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cataract surgery
* 18 years of age or older

Exclusion Criteria:

* Reported allergy or hypersensitivity to iodine or chlorhexidine
* Active ocular infection
* Contraindication to surgery
* Pregnant women
* Patients residing in nursing homes or prison
* Patients who used antibiotic, antiviral or antifungal eye drops in the week preceding the intervention

Primary outcomes:
measure: Conjunctival composition
timeFrame: 3 days. Conjunctival swabs were taken at baseline and after 3 days of treatment.
Secondary outcomes:
measure: Patient pain score
timeFrame: Day 3: after 3 days of treatment
measure: Compliance of the patients
timeFrame: Day 3: after 3 days of treatment
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study officials:
affiliation: Università degli Studi di Brescia
name: Vito Romano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05014724: CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)
Official title: CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Keywords: Chronic inflammatory demyelinating polyradiculoneuropathy
CIDP
UCB7665
rozanolixizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2021-08-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This Post Trial Access (PTA) Program enables access to rozanolixizumab for eligible patients who have taken part in the CIDP04 trial (NCT04051944) and are continuing to derive benefit from treatment.


Eligibility criteria: Inclusion Criteria:

* Patient who has taken part in the CIDP04 (NCT04051944) study
* Patient who derives continued benefit from treatment
* All required safety information has been reported as per local laws/regulations, reported to Bionical, as appropriate, and documented in the patient's medical records
* Patient is not pregnant

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
Clinical trial NCT04389424: Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer
Official title: Evaluation of the Relationship Between Drug Therapy, Food Consumption, Body Composition and Plasma Micronutients Levels With the Expression of Genes Related to Metabolism, Aging and Immunity in Women With Breast Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Endocrine Therapy
Endocrine Therapy Adverse Reaction
Vitamin D Deficiency
Nutrition Disorders
Obesity
Keywords: Vitamin D
Adverse
Cytochrome p450
VDR
Nutrients
Gene Expression
Tamoxifen
Anastrozole
Exemestane
Lead sponsor: Instituto Jalisciense de Cancerologia
Sponsor class: OTHER_GOV
Collaborators: name: University of Guadalajara
First posted: 2020-05-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Mexican breast cancer woman

Brief summary: The protocol involves measurement of 25 hidroxy vitamin D, gene expression of cytochrome and vitamin D receptor , endoxifen, tamoxifen, exemestane, and other metobolites related to nutrition and endocrine metabolism.


Eligibility criteria: Inclusion Criteria:

* Breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy
* Signed consent

Exclusion Criteria:

* Mental retardation

Primary outcomes:
measure: Hidroxy Vitamin D Concentration
timeFrame: One time after minimum 3 months of tamoxifen, anastrozole or exemestane treatment (endocrine therapy)
measure: Body Composition
timeFrame: One time at enroll with at least 3 months of endocrine therapy
Secondary outcomes:
measure: Tamoxifen plasma levels
timeFrame: One time. After minimum 3 months of tamoxifen treatment
measure: Anastrozole
timeFrame: One time. After minimum 3 months of anastrozole treatment
measure: Exemestane
timeFrame: One time. After minimum 3 months of exemestane treatment
measure: Recurrence
timeFrame: One time. In recurrence after at least 3 months with endocrine therapy
Other outcomes:
measure: Food consumption recall 24 hours (ASA 24)
timeFrame: At enroll
Locations:
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Cancerologia
state: Jalisco
Study officials:
References: