louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06143826: Progressive Muscle Relaxation Exercise on Care Burden, Depression, Anxiety, and Stress Levels in Dementia Caregivers
Official title: Progressive Muscle Relaxation Exercise on Care Burden, Depression, Anxiety and Stress Levels in Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burden
Dementia
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The research is a pre-test, post-test, cross-sectional, descriptive research.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dementia, which leads to deterioration in cognitive and behavioral functions, is a chronic progressive disease. Since the diagnosis is made, the care needs of the patients increase. In the later stages of the disease, it becomes completely dependent on the caregiver.

they are coming. Caregiving is performed by family members in developing countries such as Turkey. Family members face many difficulties in their social, work, and daily lives after they start to care. These difficulties are the burden of caregiving is called. Caregivers who perceive the burden of care also experience anxiety, stress, and depression. Jacobson progressive muscle relaxation in coping with these problems exercises can be used. This study was planned to examine the effects of progressive muscle relaxation exercises on anxiety, stress, depression, and caregiver burden in dementia caregivers.

Detailed description: The research is a pre-test, post-test, and cross-sectional research. After explaining the purpose of the study to the caregivers who met the inclusion criteria, the Information Form, the Depression Anxiety Stress-21 Scale (DAS-21), and the Zarit Care Burden Scale will be administered. Then, progressive muscle relaxation exercises will be applied to caregivers. During the interview, the audio recording of the exercise will be given to them. Also, contact information (caregiver and researcher) will be shared mutually.

Eligibility criteria: Inclusion Criteria:

* Be over 18 years old
* Being literate
* Not having difficulties in verbal communication
* Have been caring for at least 3 months
* Being able to provide care for free
* Being the primary caregiver of the patient
* Not having a psychiatric diagnosis
* Not using medication for psychiatric illness

Exclusion Criteria:

* Providing care for less than 3 months
* Providing paid care

Primary outcomes:
measure: Caregiver burden
timeFrame: At the end of the 3 months, the Zarit caregiver burden scale will be applied.
Secondary outcomes:
measure: Depression, anxiety and stress
timeFrame: At the end of the 3 months, the Depression, anxiety and stress scale-21 will be applied.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Alzheimer daily life home
Study officials:
References:
Clinical trial NCT04655326: Probiotic Therapy for Children and Adults With Autism Spectrum Disorder
Official title: Assessment of Customized Probiotic Therapy for Children and Adults With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Autism Spectrum Disorder
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Sun Genomics
First posted: 2020-12-07
Enrollment: 350
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant receives a customized probiotic based on the results of the measurement of their gut microbiota
Primary purpose: TREATMENT

Brief summary: This is a study of the effect of a customized probiotic on children and adults with autism, including effects on autism symptoms and gastrointestinal symptoms.

Detailed description: SunGenomics provides its customers with a customized probiotic based on an analysis of the microbiota in their stool samples. Customers who have autism spectrum disorders are invited to participate in this study by completing several questionnaires about their medical history, diet, autism symptoms, and gastrointestinal symptoms before taking the probiotic, and to repeat those questionnaires approximately 3 months later. This is effectively an open-label study.

Eligibility criteria: Inclusion Criteria:

1. New client of Sun Genomics (has applied for testing and treatment, but not yet begun treatment)
2. Diagnosis of ASD (initially based on self-report of ASD diagnosis by appropriate medical professional, and then verified by an evaluation of the Social Responsiveness Scale (SRS-2) by ASU staff.
3. Children and adults ages 2.5-75 years

Exclusion Criteria:

1. Antibiotic use in the last two months (not counting topical antibiotics)
2. Any changes in medications, nutritional supplements, therapies, in the last two months, or any plans to change them during the first 3 months of probiotic treatment.

Primary outcomes:
measure: Parent Global Impressions of Autism
timeFrame: change in score between baseline and 3 months
Secondary outcomes:
measure: Social Responsiveness Scale
timeFrame: change in score between baseline and 3 months
measure: Gastrointestinal Symptom Rating Scale
timeFrame: change in score between baseline and 3 months
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
Clinical trial NCT01350726: Functional-three-dimensional Reconstruction of Liver by 99MTc-GSA-SPECT Scan
Official title: Functional-three-dimensional Reconstruction and Functional Evaluation of Liver by 99MTc-GSA-SPECT Scintigraphy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis
Hepatic Carcinoma
Keywords: Cirrhosis
Hepatic Carcinoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects were from Peking Union Medical College Hospital from May, 2008 to the end of the study.

Brief summary: The aims of this study were divided into three parts:

1. To develop a new software to carry out the functional-three- dimensional-reconstruction of the liver by 99mTc-GSA-SPECT scintigraphy
2. To probe a new dynamic model of the metabolism of the 99mTc-GSA.
3. To evaluate the liver function by 99mTc-GSA-SPECT scintigraphy before surgical treatment.

Study design:

1. Collectivity type: Prospective，randomized, controlled, multi-central clinical study.
2. Patients: The subjects were from different hospitals including: Peking Union Medical College Hospital (PUMCH).

Study arrangement:

This study was consisted of three parts:


Eligibility criteria: Inclusion Criteria:

* Patients that with benign tumor、hepatitis and hepatic carcinoma (with or without cirrhosis)diagnosed by examination of CT, ultrasound-B, and/or pathology.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03953326: HeartPhone Cancer Survivors Trial 2019
Official title: Digital Intervention to Promote Physical Activity and Improve Cardiovascular Health Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Leukemia
Lymphoma
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group pre-post change
Primary purpose: PREVENTION

Brief summary: This is a behavioral study that will examine changes in physical activity and vascular health in response to a digital tool (app) that will appear on participant's lock screen of their Android phone. Participants will be asked to use this app for 3 months and to wear a Fitbit device continuously throughout the study. Participants will be asked to complete questionnaires, participate in fitness testing and measures of cardiovascular health at 3 months and 6 months after baseline assessments. The hypothesis is that exposure to the app will lead to increased physical activity volume and improved microvessel function.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Diagnosis of breast cancer, leukemia, or lymphoma \<15 yrs
* Completed chemotherapy with cardiotoxic anthracycline-based agents 1+ year ago
* English-proficiency
* Own \& use smartphone with Android operating system

Main Study and Ancillary Study Exclusion Criteria:

* Currently receiving curative treatment for cancer
* 90+ min/week moderate (or greater) intensity PA
* Any medical contraindications on the Physical Activity Readiness Questionnaire
* Require an assistive device for mobility or has any other condition that may limit or prevent participation in moderate-intensity physical activity
* Current smoker
* Pregnant or planning to become pregnant in the next 6 mos/breastfeeding
* Allergy to test substances
* Allergy to latex

Ancillary Study:

* Taking metformin
* Current medications that could conceivably alter the cardiovascular or thermoregulatory control or responses (e.g. beta blockers, calcium channel blockers, angiotensin receptor blockers)

Primary outcomes:
measure: Physical activity volume
timeFrame: 3 month
Secondary outcomes:
measure: Microvessel function
timeFrame: 3 month
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01363726: Surveillance of Rotavirus Gastroenteritis in Children <5 Years
Official title: Surveillance of Rotavirus Gastroenteritis Among Children <5 Years of Age Visiting the Pediatric Emergency Room in Southern Israel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroenteritis
Rotavirus Infections
Keywords: surveillance Rotavirus Gastroenteritis Children
< 5 years of age
southern Israel
Signed informed concent
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 30000
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Survieillance of Rotavirus Gastroenteritis Among Children Bedouin and Jewish \< 5 years with gastro enteritis visiting the ER in southern Israel

Brief summary: The purpose of this study is to monitor diarrheal disease and observe changes after the introduction of the rota vaccine.

Detailed description: Monitoring of diarrheal disease and observe changes after the introduction of the rota vaccine Comparing the epidemiology in Jewish and Bedouin population before and after the introduction of the rota vaccine into the national immunization program

Eligibility criteria: Inclusion Criteria:

1. Children \< 5 years with
2. Gastro enteritis
3. Visiting the ER
4. Residents of southern Israel
5. Signed informed concent -

Exclusion Criteria:

Not all of the above

Primary outcomes:
measure: epidemiology of rota virus disease in southern Israel before and after the rota virus vaccine introduction
timeFrame: 7 years
Secondary outcomes:
measure: To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations.
timeFrame: 7 years
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Pediatric infectious disease unit Soroka U medical center
Study officials:
References:
Clinical trial NCT00829257: Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma
Official title: A Proof of Concept Study to Evaluate the Additive Effects of HFA-BDP (Qvar) to Fluticasone/Salmeterol (Seretide) on Surrogate Markers of Small and Large Airway Inflammation in Refractory Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2009-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.


Eligibility criteria: Inclusion Criteria:

* Refractory, non-smoking asthmatics with FEV1 les than 80% predicted
* RV greater than 100% predicted and CANO greater than 3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication.
* Informed consent and ability to perform exhaled nitric oxide assessment.
* Participants must be on greater than 500mcg of fluticasone per day to enter dose ramp run-in.

Exclusion Criteria:

* Recent respiratory infection or oral steroid use.
* Pregnancy or lactation.
* Known or suspected contra-indication to any of the IMP's.
* CANO less than 3ppb, FEV1 greater than 80% or RV less than 100% at post-optimisation visit.

Primary outcomes:
measure: Alveolar nitric oxide
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Asthma and Allergy Research Group, Ninewells Hospital and Medical School
state: Scotland
Study officials:
affiliation: University of Dundee
name: Peter A Williamson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williamson PA, Short PM, Vaidyanathan S, Lipworth BJ. Inhaled and systemic corticosteroid response in severe asthma assessed by alveolar nitric oxide: a randomized crossover pilot study of add-on therapy. Br J Clin Pharmacol. 2013 Jan;75(1):93-102. doi: 10.1111/j.1365-2125.2012.04319.x.
Clinical trial NCT04505657: Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography
Official title: Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUCD Complication
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

Brief summary: our aims to investigate the effectiveness of10% Lidocaine Spray plus oral celecoxib for Pain Control During Hysterosalpingography

Detailed description: hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Eligibility criteria: Inclusion Criteria:

* any patient came for Hysterosalpingography

Exclusion Criteria:

* any patient has contraindication to Hysterosalpingography

Primary outcomes:
measure: Mean pain score during the procedure
timeFrame: 10 minuets
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT01670357: Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome
Official title: Placebo Controlled, Dose-Response, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of DA-6034 Eye Drops in Patients With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Keywords: Dry Eye Syndrome
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-22
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared with placebo in dry eye syndrome.

Detailed description: Eligible subjects are randomly assigned to receive 3% DA-6034, 5% DA-6034 or Placebo. This study is conducted for 6 weeks(Run-in Period 2 weeks + Treatment Period 4 weeks).

Eligibility criteria: Inclusion Criteria:

1. Age≥20
2. Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months
3. Fluorescein corneal staining score ≥ 4 and Schirmer test I ≤ 7mm in same eye
4. Corrected vision ≥ 0.2 in both eye
5. Have given a written, informed consent

Exclusion Criteria:

1. Ocular disorder that may confound interpretation of study results
2. Current treatment for glaucoma or IOP over 25mmHg
3. Ocular surgery history within 1 year
4. Other malignancy history or uncontrolled severe disease within 5 years
5. Use of systemic immunosuppressive therapies within 3 months
6. Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks
7. Received any other investigational drugs within 4 weeks
8. Subjects who are willing to wear contact lenses during study participation
9. Pregnant or lactating women

Primary outcomes:
measure: Change from baseline of Fluorescein Corneal Staining(FCS) score
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline of Tear Break-Up Time(TBUT)
timeFrame: 4 weeks
measure: Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score
timeFrame: 4 weeks
measure: Change from baseline of Schirmer Test I score
timeFrame: 4 weeks
measure: Change from baseline of Ocular Surface Disease Index(OSDI) score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: ManSoo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992757: Thromboelastography-derived Functional Fibrinogen Levels
Official title: Comparison of Thromboelastography-derived Functional Fibrinogen Levels During and After Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus of Study
Coagulation Status of Cardiac Surgery Patient
Reducing Excess Blood Transfusion
Keywords: functional fibrinogen assay
cardiac surgery
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population for this study will be elective cardiac surgical patients who will be undergoing elective primary cardiac surgery.

Brief summary: This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF or FLEV) levels obtained during the rewarming phase of cardiopulmonary bypass can provide information on coagulation status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements


Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgery patients who are undergoing primary cardiac surgery

Exclusion Criteria:

* Emergency surgery
* Re-operative cardiac surgery
* History of hypercoagulable state as defined in medical record
* Anticoagulated status at time of surgery
* Plasma requirement prior to discontinuation of bypass (alters fibrinogen level)

Primary outcomes:
measure: Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)
timeFrame: Change in FLEV from rewarming and after cardiopulmonary bypass
Secondary outcomes:
measure: Difference in Clauss Assay and FLEV
timeFrame: Clauss vs FLEV for rewarming and post-CPB
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania Hospital
name: Prakash A Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05319457: Testing Radon Com Methods: Clinical Trial Smartphone App vs Print Brochures
Official title: Testing Radon Com Methods: Clinical Trial Smartphone App vs Print Brochures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University of North Dakota
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to compare the effectiveness of radon information delivered via the radon app vs. a traditional approach (printed brochure). The prevalence of exceptionally high levels of residential radon in ND, coupled with public's poor understanding of this hazard, is a critical public health problem.


Eligibility criteria: Inclusion Criteria:

* The principal eligibility criterion is that participants own a smartphone.

Exclusion Criteria:

* The principal exclusion criterion is previous testing for radon within the past two years.

Primary outcomes:
measure: Ordering a free radon test kit
timeFrame: Through the study completion - 3 months
measure: Using the radon test kit
timeFrame: Through the study completion - 3 months
measure: Change from baseline radon knowledge at 3 months
timeFrame: Change from baseline knowledge level to the completion of study at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: University of North Dakota
state: North Dakota
Study officials:
affiliation: University of North Dakota
name: Soojung Kim
role: STUDY_DIRECTOR
affiliation: University of North Dakota
name: Gary G Schwartz
role: PRINCIPAL_INVESTIGATOR
References: