louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01522911: Atrial and Brain Natriuretic Peptide Secretion After Percutaneous Closure of the Left Atrial Appendage
Official title: Interventional Study to Investigate the Effects of Percutaneous Closure of the Left Atrial Appendage on Atrial and Brain Natriuretic Peptide Secretion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Stroke Prevention
Left Atrial Appendage
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 50
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: To date there are no data suggesting substantial effects of hormonal interaction after percutaneous closure of the left atrial appendage (LAA). Our hypothesis is that by excluding the LAA from blood flow physiologic stimuli for ANP and BNP produce may be impaired and consecutive release of the hormones may be reduced. Here, we present our experience of ANP and BNP secretion in the early postprocedural period after transcatheter closure of the LAA.


Eligibility criteria: Inclusion Criteria:

* non-valvular atrial fibrillation
* increased risk for thromboembolic complications (a minimum CHADS2Score of at least 2)

Exclusion Criteria:

* Valvular-atrial fibrillation
* Low risk for thromboembolic complications CHADS-2-Score \< 2

Primary outcomes:
measure: Change from Baseline Plasma ANP and BNP levels after transcatheter closure of the left atrial appendage.
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: HearCenter Leipzig
name: Nicolas Majunke, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: HearCenter Leipzig
name: Sven Moebius-Winkler, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: HearCenter Leipzig
name: Gerhard Schuler, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06096311: Improvement of Hyperglycemia/Diabetes in Patients to Improve Safety
Official title: Improvement of Hyperglycemia/Diabetes in Patients to Improve Safety
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Provider Group: A clinical multidisciplinary team including inpatient endocrine nurse practitioners, nurse coordinators, diabetes educators, outpatient nurses, attending physicians, and pharmacists.

Patient, Caregiver and Layperson Group: The patients who have diabetes/hyperglycemia seen by the Glucose Management Service, the diabetes educator, or the endocrinology service. Caregivers will only be identified by patients if there was a member of their family who helped them with their diabetes management. Laypersons will be identified by research staff as members of the community that can directly advance research and solution development in the field.

Stakeholder Group: Any and all stakeholders that are currently involved in the specific care delivery of diabetes.

Brief summary: The goal of this project is to bring together staff and clinicians from Northwestern University/Northwestern Medical Group/Northwestern Memorial Hospital as well as patients and caregivers to assess and redesign the identification and management of hyperglycemia and diabetes during and in transitions of care. There will be 3 different groups for the study: a group of providers \[Group 1\], a group of patients/caregivers and laypersons \[Group 2\], and a stakeholder group \[Group 3\]. Participants will be asked to provide input on potential interventions for a future clinical trial.


Eligibility criteria: Inclusion Criteria:

* Provider Group: Multidisciplinary clinical team (including but not limited to inpatient endocrine nurse practitioners, nurse coordinators, diabetes educators, outpatient nurses, attending physicians, and pharmacists)
* Patient, Caregiver and Layperson Group: Patients must have had hyperglycemia or diabetes at Northwestern Memorial Hospital in the last 5 years.
* Stakeholder Group: Involved in the specific care delivery of diabetes

Exclusion Criteria:

* Provider Group: None
* Patient, Caregiver, and Layperson Group: Patients will be excluded if they did not have diabetes or had hyperglycemia.
* Stakeholder Group: None

Primary outcomes:
measure: Qualitative Results from Interviews
timeFrame: Up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT00116311: Effects of Allergen Inhalation on Adenosine Receptor Expression in Sputum and Peripheral Blood
Official title: Effects of Allergen Inhalation on Adenosine Receptor Expression and Mast Cell Activation in Peripheral Blood and Sputum of Asthmatics and Healthy Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Healthy
Keywords: Adenosine receptors
asthma
sputum
peripheral blood
healthy
Lead sponsor: Groningen Research Institute for Asthma and COPD
Sponsor class: OTHER
First posted: 2005-06-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to determine whether asthmatics have different adenosine receptor expression profiles than healthy controls. We hypothesize that asthmatics will have increased adenosine receptor expression versus control subjects.

We also want to study the effects of allergen inhalation on adenosine receptor expression in asthmatics. We believe that adenosine receptor expression will be upregulated after allergen inhalation.

Both hypotheses are being tested in sputum and peripheral blood.


Eligibility criteria: Asthmatic Subjects - Inclusion Criteria:

* Clinical diagnosis of asthma
* Steroid naive or subjects not using their inhaled steroids for the last 4 weeks, short-acting beta-agonist for rescue medication
* FEV1 \> 70% of predicted
* Positive skin prick test for house dust mite, cat or grass pollen
* PC20 methacholine or histamine \< 8 mg/ml

Asthmatic Subjects - Exclusion Criteria:

* Use of systemic steroids in the previous 6 weeks
* Asthma exacerbations in the previous 6 weeks
* Current or ex-smokers with ≥ 10 pack-years (≥ 2 pipe pack-years), ex smokers who stopped less than 1 year ago

Healthy Subjects - Inclusion Criteria:

* No airway complaints
* FEV1 \> 90% of predicted
* Negative skin prick test
* PC20 methacholine or histamine \> 8 mg/ml

Healthy Subjects - Exclusion Criteria:

* Use of steroids in the previous 6 weeks
* Current or ex-smokers with ≥ 10 pack-years (≥ 2 pipe pack-years), ex smokers who stopped less than 1 year ago

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen, Department of Pulmonology
Study officials:
affiliation: University Medical Center Groningen, Department of Pulmonology, hanzeplein 1, 9713 GZ Groningen, The Netherlands
name: Dirkje S Postma, prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00810511: Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period
Official title: Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 213
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 purpose of this trial is to compare two different contact lenses during 4 weeks of wear.


Eligibility criteria: Inclusion Criteria:

* Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
* Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
* Replace lenses on a weekly or longer schedule
* Other protocol inclusion/exclusion criteria may apply

Exclusion Criteria:

* Requires concurrent ocular medication
* Eye injury or surgery within twelve weeks immediately prior to enrollment
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
* Current soft toric lens wearers
* Those who dispose of their soft lenses on a daily basis
* Current NIGHT \& DAY® or Biofinity® lens wearers
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Comfort at End of Day
timeFrame: After 4 weeks of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03990311: Prepared Meals to Prime and Perpetuate Reduced Dietary Sodium Intake in Hemodialysis
Official title: Prepared Meals to Prime and Perpetuate Reduced Dietary Sodium Intake in Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension in Dialysis Patients
Fluid Overload in Dialysis Patients
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a randomized clinical trial in which maintenance hemodialysis patients will be provided with salt restricted 'dialysis friendly' meals and compared to a control arm receiving usual care.

Detailed description: Patients randomized to the intervention arm will receive 2 months of meals plus dietary counseling. Counseling will continue for an additional 3 months while the control arm will have 5 months of usual care followed by 2 months of meal provision. Effects on interdialytic weight gain, achievement of target dry weight, intradialytic hypotension episodes, blood pressure, and a volume assessment using lung U/S to assess lung water will be measured. Salt sensitivity will be tested throughout the study. Self reported questionnaires about the burden of adhering to the low salt diet and the level of adherence with it will be completed at baseline and throughout the study. The investigator hypothesizes that the prepared meals with prime patients behavior and may alter salt taste perception and that these effects will be sustained after the prepared meals have stopped.

Eligibility criteria: Inclusion Criteria:

1. Age \>18
2. Treated with outpatient hemodialysis for \>60 days
3. Mean IDWG over the past 30 days \>2 kg
4. Speaks and understands English or Chinese
5. Patient has a freezer at home with space to store at least 7 prepared meals
6. Cognitively intact (able to provide informed consent and answer questionnaires)

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Interdialytic Weight Gain throughout Length of Study
timeFrame: Every two weeks starting through 5months (intervention arm)/ 7 months (control arm)
Secondary outcomes:
measure: Rate of Intradialytic Hypotension Episodes throughout Length of Study
timeFrame: Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm)
Other outcomes:
measure: Pre-dialysis Blood Pressure
timeFrame: through 5months (intervention arm)/ 7 months (control arm)
measure: Salt Taste Perception
timeFrame: through 5months (intervention arm)/ 7 months (control arm)
measure: Salt Taste Preference
timeFrame: through 5months (intervention arm)/ 7 months (control arm)
measure: Fluid Overload
timeFrame: through 5months (intervention arm)/ 7 months (control arm)
measure: Rate of Achievement of Estimated Dry Weight
timeFrame: through 5months (intervention arm)/ 7 months (control arm)
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT06672211: Vıdeo-Assısted Stoma Care Traınıng Gıven To Patıents Wıth Stoma Adaptıng To Stoma and Complıcatıons
Official title: Effect of Video-Assisted Stoma Care Education Given to Patients With Stoma on Postoperative Anxiety, Adapting to Stoma and Complications: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma - Ileostomy
Stoma Colostomy
Stoma
Education of Patients
Keywords: stoma
İleostomi
Colostomy
Education of Patients
Lead sponsor: Hatay Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: The aim of this study is to evaluate the effects of video-assisted stoma care training given to patients with stoma on postoperative anxiety, stoma compliance and complications.

Materials and Methods: This study was conducted as a double-blind randomized controlled interventional study within the scope of a doctoral thesis between January 2021 and September 2022 at the General Surgery Clinics of Aydın Atatürk State Hospital, Aydın State Hospital and Aydın Adnan Menderes University Practice and Research Hospital with 42 patients, 21 in the intervention group (who received video-assisted stoma care training in the postoperative period) and 21 in the control group, who met the sampling criteria. In the postoperative period, patients in the intervention group were given video-assisted stoma care training, while patients in the control group were given training using plain narration and demonstration methods. During the research process, patients were visited at 3 different time periods to determine the patients' anxiety levels, evaluate their compliance with the stoma and complications, and the patient follow-up was concluded.


Eligibility criteria: Inclusion Criteria:

* Having a stoma
* Being over 18 years old
* Having no complications from the stoma

Exclusion Criteria:

* Having developed any complications in the stoma

Primary outcomes:
measure: State-Trait Anxiety Scale
timeFrame: Pre-training 1 day and Post-training 1 day
Secondary outcomes:
measure: Adaptation Scale for Individuals with Stoma
timeFrame: 1 day Pre-training and Post-training 1 day
measure: Pittman Ostomy Complication Severity Index
timeFrame: Post-training 1 week
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Health Sciences Institute
state: Merkez
Study officials:
affiliation: Adnan Menderes Üniversity
name: Senem GÜNEŞ KARA, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01550211: Changes in Brain Synchronization During Perceptual and Linguistic Tasks in Schizophrenic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenic Patients
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: Bar-Ilan University, Israel
First posted: 2012-03-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Chronic patients - Up to 30 chronic schizophrenic patients.
2. Naive patients - Up to 30 unmedicated first episode schizophrenic patients.
3. Patients' relatives - Up to 60 family members (parents or siblings) of the participants - control group 1.
4. Students - Up to 30 students from Bar-Ilan University - control group 2.

Brief summary: This study aims to identify electrophysiological correlates of impaired perceptual and linguistic processes in chronic schizophrenic patients, un-medicated first-episode schizophrenic patients and their healthy relatives.

Following administrating some questionnaires (demographic details and psychiatric history questionnaire, handedness questionnaire, reading abilities test and positive and negative symptoms questionnaire) and performing a perception test and a verbal abstract intelligence test, participants will conduct a brain scan during a series of perceptual and linguistic tasks.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria for chronic patients:

* Hebrew native speakers.
* Diagnosis of schizophrenia with a history of more than one episode.
* Capable and willing to provide informed consent.

Inclusion criteria for naive patients:

* Hebrew native speakers.
* Diagnosis of schizophrenia with a history of only one episode and unmedicated.
* Capable and willing to provide informed consent.

Inclusion criteria for patients' relatives (control group 1):

* Hebrew native speakers.
* Without any psychiatric history.
* Have a child and/or a sibling with schizophrenia.

Inclusion Criteria for students (control group 2):

* Hebrew native speakers.
* Without any psychiatric history.

Exclusion Criteria:

Exclusion Criteria for patient groups (chronic and "naïve"):

* Left handedness.
* Reading disability.
* Visual perception disability.
* Brain damage and/or a history of seizures.
* Impaired intelligence.
* Metal implants.

Exclusion Criteria for control groups (family members and students):

* Psychiatric history.
* Left handedness.
* Reading disability.
* Visual perception disability.
* Brain damage and/or a history of seizures.
* Impaired intelligence.
* Metal implants.

Primary outcomes:
measure: Magnetic field amplitude and source
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hod-Hasharon
country: Israel
facility: Shalvata MHC
Study officials:
affiliation: Shalvata MHC
name: Hilik Levkovitz, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02811211: A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With ADHD
Official title: A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Avalo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-23
Enrollment: 1894
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects between the ages of 6 years and 17 years of age with a previously established diagnosis of ADHD will be eligible for screening.

Brief summary: This noninterventional study will assess genomic changes in the metabotropic glutamate receptor (mGluR) network in children and adolescents with ADHD.

Detailed description: Male and female subjects 6 to 17 years of age with a primary psychiatric diagnosis of ADHD will be enrolled in this study. The subject and his or her parent/guardian must agree to genotyping to determine whether the subject has disruptive mutations within any of the approximately 274 mGluR-network genes, and complete an interview that will include information about the subject's ADHD history, treatment, and co-morbidities.

Eligibility criteria: Inclusion Criteria:

* The subject is male or female ≥6 and ≤17 years of age.
* The subject has ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.
* The subject, his or her legally responsible representative, and investigator agree to complete ADHD history, treatment, and comorbidity electronic case report form (eCRF).

Exclusion Criteria:

* The subject or parent/legal guardian is in the opinion of the investigator mentally or legally incapacitated and unable to provide informed consent/assent for participation in the study.

Primary outcomes:
measure: Presence of mGluR network mutations
timeFrame: At study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: A.I. DuPont Hospital for Children
state: Delaware
Study officials:
References:
Clinical trial NCT04882111: ALIGN Intervention in Patients With Advanced Cancer Discharging to a SNF
Official title: ALIGN - A Palliative Care Social Work Intervention for Cancer Patients Discharging to a Skilled Nursing Facility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cancer
Keywords: Palliative
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Icahn School of Medicine at Mount Sinai
First posted: 2021-05-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a single arm, pre-post, pilot study assessing the feasibility and acceptability of the ALIGN intervention in metastatic adult cancer patients discharging to local area SNFs.

Detailed description: A novel approach for delivering high quality palliative care for cancer patients discharging to a skilled nursing facility (SNF) is critically needed. This investigator plans to test a palliative care social work led intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) that aims to define patient and caregiver goals, facilitate communication between patients and their care teams, and develop a patient-centered plan that accompanies the patient across all future health system transitions. The central hypothesis is that implementation of ALIGN is feasible and acceptable for cancer patients and their caregivers and SNF staff.

Eligibility criteria: Inclusion Criteria:

1. Stage II - IV solid tumor malignancy
2. Discharging from an acute care hospital to a SNF in the metro Denver area
3. Decisional capacity to consent
4. English speaking
5. (During COVID requirements) Either internet access through a computer, tablet, or smartphone OR cellular service with adequate allowance of cellular minutes to allow virtual visits (by participant's assessment)

Exclusion Criteria:

1. Discharging with hospice as their goal of care

Primary outcomes:
measure: Subject retention
timeFrame: Two Years
Secondary outcomes:
measure: Qualitative interviews of ALIGN participants
timeFrame: 1.5 years
measure: Qualitative interviews of SNF staff
timeFrame: 1.5 years
Other outcomes:
measure: Advanced Illness Coordinating Care Survey
timeFrame: Baseline and 60 days
measure: Goal alignment measurement
timeFrame: Baseline and 60 days
measure: FACIT-Pal
timeFrame: Baseline and 60 days
measure: Advance Care Planning documentation
timeFrame: Baseline and 60 days
measure: Decision Regret Scale
timeFrame: Baseline and 60 days
measure: Caregiver Reaction Assessment
timeFrame: Baseline and 60 days
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
References: