louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05053893: Roxadustat Combined With Sacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome
Official title: A Randomized, Parallel Controlled Trial of Roxadustat Combined withSacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardio-Renal Syndrome
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized and parallel controlled trial design of comparing the new treatment group of Roxadustat combined with Sacubitril Valsartan Sodium Tablets with the traditional treatment group of recombinant human erythropoietin (EPO) combined with ACEI or ARB in Chinese patients with cardiorenal anemia syndrome.


Eligibility criteria: Inclusion Criteria:

* diagnosed as regular dialysis patients with cardiorenal anemia syndrome
* Hemoglobin 60-110g / L (twice with an interval of at least 4 days);
* Volunteered to participate

Exclusion Criteria:

* Anemia caused by diseases other than CKD
* Malignant tumors
* Active liver disease
* Rheumatic immune diseases in active stage
* Hereditary or idiopathic angioedema
* Systolic blood pressure≥180 mmHg;diastolic blood pressure≥110 mmHg
* Acute myocardial infarction and unstable angina pectoris
* Severe parathyroidism
* Active peptic ulcer
* taking aliskiren
* Mental disease
* Alcohol and drug abuse
* Allergy to test drugs

Primary outcomes:
measure: Changes of hemoglobin level before and after treatment
timeFrame: Day0-Day90
measure: Changes of ejection fraction before and after treatment
timeFrame: Day0-Day90
measure: Incidence of acute heart failure, acute myocardial infarction, severe hyperkalemia and severe anemia during treatment
timeFrame: Day0-Day90
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Department of Nephrology, Affiliated Hospital of Qingdao University
state: Shangdong
Study officials:
References:
Clinical trial NCT03948893: Smoking Cessation Behavioral Treatment Study
Official title: Neural Mechanisms Mediating Appetitive Regulation and Smoking in Nicotine Addiction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
First posted: 2019-05-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effectiveness of two behavioral interventions on smoking behavior - Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT). MORE is a behavioral therapy that integrates mindfulness training to modify reward processes. CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.


Eligibility criteria: Inclusion Criteria:

* Age 18 and up
* English fluency as demonstrated in providing informed consent and the ability to independently follow directions in completing assigned assessments and tasks
* Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks
* Current nicotine dependent smoker with a minimum smoking history of 2 years
* Interest in quitting smoking

Exclusion Criteria:

* Use of psychotropic (e.g. antiepileptic) medications in the past month
* Positive urine drug screen
* Presence of an untreated medical illness
* Current or past psychosis
* History of major neurological illness or head injury resulting in loss of consciousness
* And contraindication to MRI, including claustrophobia
* Among females, positive urine pregnancy test
* Inability or unwillingness of subject to give informed consent

Primary outcomes:
measure: Cigarette Smoking
timeFrame: 7 weeks
measure: Magnitude of change in fMRI brain response to images
timeFrame: 7 weeks
measure: Magnitude of change in fMRI brain connectivity
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri - Columbia
state: Missouri
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT01508793: Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors
Official title: Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Obesity
Keywords: Sleep
Obesity
Children
Eating behaviors
Activity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Temple University
First posted: 2012-01-12
Enrollment: 103
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study aims to determine whether an intervention to increase sleep in school-age children is associated with positive changes in eating, activity behaviors and zBMI. One hundred four children 8-11 years old who sleep 9 ½ hours or less per night will be randomly assigned to 1 of 2 conditions: 1) optimize sleep (increase TIB by 1 ½ hours/night to produce a change in sleep duration of approximately 40 minutes/night), or 2) control (no change in sleep). Families of children in the optimize sleep group will be taught effective behavioral strategies that have been shown to improve sleep duration. At baseline, 2-week and 2-month follow-up, the following will be gathered: sleep duration (measured by actigraphy), food intake (measured by 3 days of 24-hour recall), activity level (measured by accelerometry), the relative reinforcing value (RRV) of food (measured using a validated experimental paradigm), and measured child height and weight.


Eligibility criteria: Inclusion Criteria:

* Age 8-11 years old
* BMI for age and gender \> 10th percentile (but no greater than 100% overweight)
* Sleep 9.5 hours or less nightly
* Attend elementary school
* Like at least 1 food used in the reinforcement paradigm
* Able to understand and complete the reinforcement paradigm

Exclusion Criteria:

* Existence of a diagnosable parasomnia, sleep disordered breathing
* Medical or psychiatric condition that could influence sleep or weight
* Inability to complete study materials, including diagnosed disabilities
* Dietary restrictions/allergies to foods used in the study that preclude them from study participation

Primary outcomes:
measure: Change in Sleep Duration
timeFrame: Baseline, 2-weeks, and 2-months
measure: Change in Dietary Intake
timeFrame: Baseline, 2-weeks, and 2-months
Secondary outcomes:
measure: Change in the Reinforcing Value of Food
timeFrame: Baseline, 2-weeks, and 2-months
measure: Change in activity
timeFrame: Baseline, 2-week, and 2-month
measure: Change in zBMI
timeFrame: Baseline, 2-week, and 2-month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Obesity Research and Education
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Temple University
name: Chantelle N Hart, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03435393: Ripple Mapping for Epicardial Mapping of Brugada Syndrome
Official title: Ripple-Mapping for the Detection of Long Duration Action Potential Areas in Patients With Brugada Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brugada Syndrome
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Brugada syndrome and an episode of ventricular tachycardia

Brief summary: Whether a mapping algorithm "Ripple-mapping" is able to rapidly identify the areas of long-duration multicomponent electrograms which constitute the targets for ablation for an automated strategy remains to be assessed.


Eligibility criteria: Inclusion Criteria:

* Brugada syndrome patients requiring ablation

Exclusion Criteria:

* Patients not able to consent

Primary outcomes:
measure: Eradication of Brugada syndrome pattern
timeFrame: 24h post procedure
Secondary outcomes:
measure: Freedom from ventricular arrhythmias
timeFrame: 12 months post-procedure
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coracao
city: Lisbon
country: Portugal
facility: Hospital de Santa Cruz
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
References:
Clinical trial NCT01550393: Biomarkers in Urine Samples From Patients With Wilms Tumor
Official title: Discovery and Validation of Wilms Tumor Markers Using Urine Proteomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Keywords: stage II Wilms tumor
stage III Wilms tumor
recurrent Wilms tumor and other childhood kidney tumors
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-12
Enrollment: 100
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage II-III Wilms tumors

Brief summary: RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial studies biomarkers in urine from patients with Wilms tumor.

Detailed description: OBJECTIVES:

* To validate the prognostic performance of specific-candidate Wilms tumor markers by measuring their urinary concentration using enzyme-linked immunosorbent assays (ELISAs) in urine specimens collected at diagnosis from 50 patients with favorable histology Wilms tumor who relapsed and 50 patients who did not relapse.

OUTLINE: Urine specimens are analyzed using enzyme-linked immunosorbent assays (ELISAs) for biomarkers.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Urine specimens collected at diagnosis will be selected from patients with stage II-III Wilms tumors, with both local and non-local sites of disease relapse
* Clinical patient information (urinalysis/macro, age, gender, congenital defects/syndromes, comorbidities, tumor stage, size, pathology, therapy, outcome) available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Wilms tumor biomarkers identified by ELISA
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Elizabeth A. Mullen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05272293: Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With AML
Official title: Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With High-risk, Refractory or Relapsed AML
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: Natural killer cells, immunotherapy
Lead sponsor: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells for children/young adults with primary high risk or refractory AML and relapsed AML.

Detailed description: Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line.

For patients with high-risk primary AML a cycle of immunotherapy includes chemotherapy (HD-ARA-C+IDA) followed by three doses of NK cells infusion.

For patients with refractory/relapsed AML a cycle of immunotherapy includes chemotherapy (FLAG - fludarabine, cytarabine, G-CSF) followed by three doses of NK cells infusion.

A 2nd cycle of therapy may be administered if a recipient continues to meet the eligibility criteria.

Eligibility criteria: Inclusion Criteria:

Patients:

* primary high risk AML
* primary refractory AML
* relapsed AML
* Karnofsky or Lansky performance scale greater or equal to 70
* written informed consent

Donors:

* haploidentical family donor
* donor suitable for cell donation and apheresis according to standard criteria
* written informed consent

Exclusion Criteria:

Patients:

* uncontrolled infection
* severe hepatic dysfunction: SGOT or SCPT \>=5x upper limit of normal for age
* positive serology for human immunodeficiency virus (HIV)

Donors:

* pregnancy
* positive serology for HIV, hepatitis B or C

Primary outcomes:
measure: Objective Response Rate (ORR) (PR+ MLFS+CRi +CR)
timeFrame: 30 days after every a course of NK immunotherapy
measure: Leukemia-free survival (LFS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 1 year
Secondary outcomes:
measure: Duration of persistence of infused NK cells
timeFrame: 21 days after the first infusion
measure: Number of T, B, NK, activated T and NK cells after immunotherapy
timeFrame: 30 days after the first infusion
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
state: Minsk Region
Study officials:
affiliation: Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
name: Olga Aleinikova, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01062893: Combined Spinal/Epidural (CSE) Saline Duration/Spread
Official title: Effect of Epidural Saline on Duration and Spread of Subsequent Spinal Analgesia/Anesthesia Using a CSE Technique
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Labor Pain
Keywords: labor pain treatment
duration analgesia
Analgesic duration with normal saline injection.
Analgesic duration without normal saline injection
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 82
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An attempt is being made to see if by injecting a set volume of sterile saline into the epidural space during the treatment of labor pain with a combined spinal/epidural (CSE) increases the amount of pain relief obtained and makes the labor analgesia lasts longer. Subjects are in the study from the time their CSE is placed until they request additional pain medication from the spinal dose of numbing medicine wearing off.


Eligibility criteria: Inclusion Criteria:

* age greater than 12 years of age
* ASA status 1 or 2
* cervical dilation \< 6cm

Exclusion Criteria:

* ASA assigned 3 or 4
* advanced labor (\> 6cm cervical dilated)
* distorted epidural anatomy

Primary outcomes:
measure: Highest Sensory Blockade Level to Pinprick and to Cold
timeFrame: up to 20 minutes
Secondary outcomes:
measure: Duration of Analgesia (Time to Request Additional Analgesia)
timeFrame: up 120 minutes
measure: Onset of Analgesia
timeFrame: up to 20 minutes
measure: Time to Highest Sensory Block
timeFrame: up to 20 minutes
measure: Number of Participants Who Had Occurrence of Fetal Bradycardia
timeFrame: length of labor, up to 24 hours
measure: Number of Participants Who Had Occurrence of Maternal Hypotension
timeFrame: length of labor, up to 24 hours
measure: Occurrence of Use of Vasopressors
timeFrame: length of labor, up to 24 hours
measure: Number of Participants Who Had Occurrence of Itching
timeFrame: length of labor, up to 24 hours
measure: Number of Participants Who Had Occurrence of Post Dural Puncture Headache
timeFrame: length of labor, up to 24 hours
measure: Time for 2 Dermatome Level Regression of Sensory Block
timeFrame: up to 20 minutes
measure: Time for Regression of Motor Blockade
timeFrame: up to 20 minutes
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Forsyth Medical Center-Sara Lee Center for Women's Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Peter H Pan, MD, MSEE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05528393: Prolactin and FGF21 in Gestational Diabetes Mellitus
Official title: Prolactin and FGF21 in Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes Mellitus in Pregnancy
Hyperprolactinemia Pregnancy
Keywords: Gestational Diabetes Mellitus
Prolactin
Insulin resistance
Fibroblast growth factor 21
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who met the above criteria were enrolled

Brief summary: Prolactin (PRL) and PRL receptor (PRLR) signaling has been validated to play an important role in the modulation of glucolipid metabolism. However, the role of serum PRL levels in gestational diabetes mellitus (GDM) remains unclear. The investigators aimed to explore the possible influence of serum PRL within or without normal range on the development of GDM.


Eligibility criteria: Inclusion Criteria:

* aged 18 to 45 years
* completed a 75-g oral glucose tolerance test (OGTT)
* females with pregnancy

Exclusion Criteria:

* severe liver and renal dysfunction, preexisting heart disease, malignancy, or endocrine diseases such as pituitary adenoma and hypogonadism
* mental illness
* genetic disease
* current or previous treatment that might affect PRL and insulin secretion
* diabetes before pregnancy
* loss to follow-up, or withdrawal from the study
* unable to understand and comply with the study protocol.

Primary outcomes:
measure: Gestational diabetes mellitus (GDM)
timeFrame: 2019-2023
measure: PRL
timeFrame: 2019-2023
Secondary outcomes:
measure: Insulin resistance (IR)
timeFrame: 2019-2023
measure: HOMA-IR
timeFrame: 2019-2023
measure: OGTT
timeFrame: 2019-2023
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
Study officials:
References:
Clinical trial NCT01065493: QuitAdvisorMD: A Point-of-care Tool for Brief Smoking Cessation Interventions
Official title: QuitAdvisorMD: A Point-of-care Tool for Brief Smoking Cessation Interventions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Smoking
Tobacco Use Disorder
Lead sponsor: Silverchair Science & Communications, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-02-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: QuitAdvisorMD: A point-of-care tool for brief smoking cessation interventions Under a Phase II SBIR grant supported by NIH/NIDA, we are developing QUITAdvisorMD: a point-of-care, patient-centered resource for counseling patients who smoke or use tobacco products. It is based on the principles of Motivational Interviewing, a non-confrontational and very effective method for intervening and treating these patients; the 5 A's of behavioral interventions; and the Transtheoretical Model of Change. Through a point and click interface, the tool uses a series of interview questions designed to motivate patients to stop smoking by first assessing their stage of change and then offering effective stage-based interventions and interview techniques. The tool also offers stage-tailored patient information, a clinician educational reference, and the ability to communicate support information patients via email and/or text message.


Eligibility criteria: Inclusion Criteria:

* any physician providing care for members of Southern Health through primary care and have access to a point-of-care computing device (Smartphone, desktop PC, etc) during patient visits.

Exclusion Criteria:

* Lack of appropriate computing device

Primary outcomes:
measure: The goal of the evaluation is to assess the ability of QuitAdvisorMD to influence smoking cessation as measured by the primary outcome of the increase in physician initiated smoking cessation counseling.
timeFrame: 12 Months
Secondary outcomes:
measure: Secondary outcomes will include, 1) the increase in ability of clinicians to provide appropriate stage-based smoking cessation assistance, and 2) the increase in patient quit attempts.
timeFrame: 12 Months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: Silverchair, Inc
name: George Reynolds, BA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia Health System
name: Scott Strayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01918293: Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma): Adult
Official title: Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma) in Adult
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BRONCHIAL ASTHMA
Keywords: ASTHMA
SMARTPHONE APPLICATION
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough, wheezing and severe life-threatening attack and lower quality of life. In addition, it make large amount of socioeconomic loss as about 3.7 billion US dollars.


Eligibility criteria: Inclusion Criteria:

* using smartphone
* alleged bronchial asthma over 3months \& positive of bronchodilator response test or bronchial provocation test

Exclusion Criteria:

* COPD
* active pulmonary TUBERCULOSIS
* Acute exacerbation within 4weeks
* severe psychological disorder
* severe systemic disease; severe LC, ESRD ...
* MALIGNANCY

Primary outcomes:
measure: The efficacy of smartphone application for asthma control test (ACT)and quality of life
timeFrame: at least 2 times a week
Secondary outcomes:
measure: FEV1 (Forced expiratory volume in 1 second ) and FVC (Forced vital capacity)
timeFrame: at least 1 time a month
measure: Acute exacerbation of bronchial asthma
timeFrame: at least 1 time a week
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital
Study officials:
References: