louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01869153: Monitoring Growth of Preterm Infants
Official title: Monitoring Growth of Preterm Infants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prematurity
Keywords: Growth, weight
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants of gestational age \< 32w at birth, or \<1750 weight at birth.

Brief summary: Growth is poor in preterm infants, partly due to difficulty identifying when growth is slow. The investigators will examine the use of a computer program to try and identify periods of growth slowing in preterm babies, and compare those results to the usual assessments made on patient care rounds.

Detailed description: We wish to examine the use of a mathematical modeling system to see if it can detect poor growth better (and more quickly) than we can clinically. To do this, we need to know what the clinical team think about a baby's growth day-to-day. However, after rounds the fellow or NNP with fill in a sheet to say what the team thought about the baby's growth (was it okay, too slow, too fast etc.), and whether any changes were made to improve the baby's growth (e.g. increased feed volume, change in composition of feeds etc.). After the baby is discharged home, weight data from the EMR will be entered into the program to try and identify times where growth slowed (or where growth was faster than expected). We will compare the results of the computer program and the record of the clinical teams thoughts on the ward round, to see if the computer program identified growth slowing more quickly than the clinical team did.

Eligibility criteria: Inclusion Criteria:

1. Birth weight \< 1750g gestational age \< 32w at birth

   Exclusion Criteria:
2. Currently receiving parenteral nutrition or intravenous lipids

Primary outcomes:
measure: Identification of growth slowing
timeFrame: Between birth and hospital discharge, an average of 10weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: NICU, University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Ian Griffin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004353: Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitochondrial Myopathy
MELAS Syndrome
Lactic Acidosis
Keywords: MELAS syndrome
inborn errors of metabolism
lactic acidosis
mitochondrial myopathy
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of California, San Diego
First posted: 1999-10-19
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Study the metabolism of pyruvate and related problems in patients with lactic acidemia.

II. Define the nature of the metabolic defect.

Detailed description: PROTOCOL OUTLINE: Patients fast for 6 hours. Glucagon IM is administered after the 6 hour fast. Glucose level is measured at 0, 15, 30, 45, 60, and 90 minutes.

In children of sufficient size, alanine and lactic acid should also be measured at each or most of these time points.

Fasting continues for at least 18 hours. Glucagon IM is administered again at end of fast. Glucose level is measured at time 0, 15, 30, 45, 60, and 90 minutes.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

* Diagnostically documented elevation in lactate, pyruvate, and/or alanine levels in lactic acidemia patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Richard H. Haas
role: STUDY_CHAIR
References:
Clinical trial NCT04361253: Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy
Official title: A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID
Infectious Disease
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.

Detailed description: Investigators are doing this research to learn more about high-titer COVID-19 convalescent plasma (HT-CCP) transfusion as a possible treatment for people who have COVID-19, the coronavirus infection. "HT-CCP" is plasma that contains a high amount of antibodies that were made to fight off COVID-19 because it is donated by another person who has also been infected with coronavirus but has recovered, so their immune system has had enough time to make these antibodies. This study is being done to determine whether HT-CCP will help people with COVID-19 recover from their infection more quickly and lower their risk of having to go on a ventilator or reduce the time they need to stay on a ventilator. It is not yet known whether HT-CCP helps people with COVID-19, which is why the study needs to be randomized, meaning some subjects will be randomly selected to receive HT-CCP while others will be randomly selected to receive FFP.

Eligibility criteria: Inclusion Criteria:

1. Age \>1 year.
2. Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR.
3. Meets institutional criteria for admission to hospital for COVID-19.
4. Admitted to ICU or non-ICU floor within 5 days of enrollment.
5. PaO2/FiO2 \>200 mmHg if intubated.
6. Patient or LAR able to provide informed consent.

Exclusion Criteria:

1. Previous treatment with convalescent plasma for COVID-19.
2. Current use of investigational antiviral therapy targeting SARS-CoV-2.
3. History of anaphylactic transfusion reaction.
4. Clinical diagnosis of acute decompensated heart failure.
5. Objection to blood transfusion.

Primary outcomes:
measure: Modified WHO Ordinal Scale (MOS) score
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Richard Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03127553: ProAliFun_6.7_Health Effects of a Low-Salt Bread on Hypertensive Subjects (ProAliFun67)
Official title: Technological and Clinical Innovative Protocols for the Production of Functional Foods - 6.7 (ProAliFun67)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: salt intake
functional food
low-salt bread
blood pressure
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
Collaborators: name: Ospedali Riuniti di Foggia
First posted: 2017-04-25
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to evaluate the health properties of a dietary intervention carried on with an innovative low-salt bread.

The hypothesis is that the introduction of a low-sodium bread as part of a low-salt diet may improve the compliance to the own regime and that the vascular function, the inflammatory and oxidative state, the composition of the intestinal microbiota and that neurocognitive and neurodegenerative processes can improve in hypertensive patients fed a low-salt diet with low-salt bread.

Detailed description: This clinical trial is a multi-center, randomized, controlled, open label, pilot study, lasting 6 months.

A target number of seventy individuals with hypertension meeting inclusion and exclusion criteria, assessed at enrollment, and which have signed the informed consent, will be recruited.

Eligibility criteria: Inclusion Criteria:

* arterial hypertension stage I-II
* stable control of blood pressure
* eGFR \> 60
* informed consent signed

Exclusion Criteria:

* uncontrolled hypertension
* therapy with diuretics
* need for therapy with more than three antihypertensive drugs
* proteinuria greater than 1 g/day
* celiac disease
* systemic inflammatory diseases
* suspicion or clinical diagnosis of malignancy
* chronic liver disease
* treatment with corticosteroids or immunosuppressive drugs
* previous acute cardiovascular diseases (myocardial infarction, stroke)
* psychiatric conditions reducing the compliance to treatment protocols

Primary outcomes:
measure: Sodium intake
timeFrame: 6 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 6 months
measure: Endothelial stress
timeFrame: 6 months
measure: Gut microbiota
timeFrame: 6 months
measure: Antioxidant status
timeFrame: 6 months
measure: Inflammation
timeFrame: 6 months
measure: Insulin sensitivity
timeFrame: 6 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AUO Policlinico Consorziale
state: BA
Study officials:
affiliation: Head of the Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari Azienda Ospedaliero-Universitaria Consorziale "Policlinico"
name: Loreto Gesualdo, MD Full Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03028753: Accuracy of Bladder Scanners in Post-operative Voiding Trials
Official title: Accuracy of Bladder Scanners in Post-operative Voiding Trials
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pelvic Floor Disorders
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators are trying to determine if using a bladder scanner (type of ultrasound) to check how much urine is left in the bladder is the same as checking that volume with a catheter (tube that goes into your bladder to drain urine). After urogynecologic surgery, the investigators perform a voiding trial. Water is put into the participant's bladder through the catheter (tube draining your bladder). The catheter is then removed and the participant is asked to empty their bladder. After that, the investigators will use the bladder scanner (ultrasound) to see how much urine is left in the participant's bladder. After the ultrasound, the investigators will pass a very small catheter (tube) into the bladder to take out the remaining urine. The investigators will then compare the amount obtained from the catheter to the ultrasound amount. This will also help the investigators to figure out if they need to check how much urine is left in a patient's bladder after the voiding trial.

Detailed description: The primary aim of this study is to determine if bladder scanners are accurate in determining a post-void residual volume (PVR) after Urogynecologic surgery.

The secondary aim of this study is to determine if a post-void residual volume (PVR) measurement is needed after a back-fill voiding trial on Urogynecologic post-op patients.

Eligibility criteria: Inclusion Criteria:

* Undergoing Urogynecologic surgery
* Able to consent
* Greater than 18 years old
* Non pregnant

Exclusion Criteria:

* Need for prolonged catheterization
* Unable to consent
* Prisoner

Primary outcomes:
measure: Determine if bladder scanners are accurate in determining a post void residual after urogynecologic surgery
timeFrame: Within 48 hours after surgery
Secondary outcomes:
measure: Determine if a post void residual volume measurement is needed after a back-fill voiding trial after urogynecologic surgery
timeFrame: Within 48 hours after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Tanaz Ferzandi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04023253: Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin
Official title: Comparisons of the Impact of Beta-3 Agonist Versus Antimuscarinics on Psychological Distress, Sexual Function, Bladder Wall Thickness and Blood Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Overactive Bladder Syndrome
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and bladder blood flow.

Detailed description: To assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and blood flow.

Eligibility criteria: Inclusion Criteria:

* Overactive bladder syndrome

Exclusion Criteria:

* Allergy to mirabegron or solifenacin.
* Patients with severe hypertension who are difficult to control, known urethral diverticulum, known bladder malignant tumors, urinary retention patients, gastric retention patients, uncontrolled angular glaucoma patients, dialysis patients, severe renal dysfunction , moderate liver dysfunction, use strong inhibitors of CYP3A4 such as ketoconazole.

Primary outcomes:
measure: Global response assessment
timeFrame: 12 weeks
Secondary outcomes:
measure: Total score of Brief Symptoms Rating Scales
timeFrame: 12 weeks
measure: Female sexual function index
timeFrame: 12 weeks
measure: Bladder wall thickness
timeFrame: 12 weeks
measure: Blood flow index of the bladder
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT03967353: Study on the Management Model of "Home Treatment" for Tuberculosis Patients
Official title: Study on the Management Model of "Home Treatment" for Tuberculosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis, Pulmonary
Keywords: Tuberculosis
Home Treatment Management
Infection Control
Lead sponsor: Beijing Chest Hospital
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims to standardize the management of "home treatment" for tuberculosis patients, improve the compliance of patients with treatment, reduce the risk of transmission, and study the establishment of "home treatment" management model for tuberculosis patients.

Detailed description: The project intends to optimize the standardized management framework and process of "home treatment" for tuberculosis patients by introducing mobile Internet technology as a means of patient management and formulating "home treatment" infection control norms, and ultimately form a management model suitable for "home treatment" for tuberculosis patients.Through prospective study to evaluate the effect of this model on the treatment compliance of "home treatment" patients and the impact on tuberculosis infection and incidence of close contacts, so as to further improve the "home treatment" management model. The research results of this project will provide policy basis for Beijing to formulate "home treatment" management of tuberculosis progress.

Eligibility criteria: Inclusion Criteria:

Pathogenic Comfirmed Positive TB patients New Pathogenic Positive Pulmonary Tuberculosis Patients Treated by Home Treatment TB assistant APP user

Exclusion Criteria:

Unconscious Unable to answer questions

-

Primary outcomes:
measure: treatment adherence
timeFrame: 6 months for each patient
Secondary outcomes:
measure: treatment success rate
timeFrame: 6 months for each patient
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chest Hospital
state: Beijing
Study officials:
affiliation: Beijing Chest Hospital, Capital Medical University
name: fengling Mi, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT02993653: Intensity-modulated Radiotherapy Protocol in Cervix Cancer
Official title: Definitive Treatment Protocol for High-dose Intensity-modulated Radiotherapy (IMRT) With Intracavitary Radiotherapy in Locally Advanced Cervical Cancer: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Radiation
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial

Detailed description: Radiotherapy

1. intensity-modulated radiotherapy of whole pelvis: 60 Gy in 30 fx Re-simulation with pelvic Magnetic resonance imaging at 46 Gy in 23 fx and intensity-modulated radiotherapy on the gross cervical and nodal tumor (initially Positron emission tomography-positive), 14 Gy in 7 fx
2. intensity-modulated radiotherapy boost of gross cervical tumor or Intra-cavitary radiotherapy (ICR)

   * Re-staging pelvic Magnetic resonance imaging , if complete response occurs Intra-cavitary radiotherapy to A point, 25 Gy in 5 fx for 2 weeks
   * Re-staging pelvic Magnetic resonance imaging I, partial response or stable disease occurs intensity-modulated radiotherapy boost , 10 Gy in 4 fx to the gross cervical tumor for 1 week

Eligibility criteria: Inclusion Criteria:

1. FIGO II-IVA Patients with untreated and histologically confirmed carcinoma of the uterine cervix
2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1
3. Patients with adequate bone marrow function: Absolute nutrophil count (ANC) greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the beginning
4. Patients with adequate renal function: creatinine equal to or less than 2.0 mg/mL
5. Patients who have signed an approved informed consent and authorization

Exclusion Criteria:

1. Patients with recurrent cervical cancer
2. Patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer
3. Patients with metastatic lymphadenopathies other than pelvis (e.g. inguinal, paraaortic, supraclavicular, or mediastinal node)
4. Patients with distant organ metastasis

Primary outcomes:
measure: Progression-free survival
timeFrame: 30 months
Secondary outcomes:
measure: Overall survival
timeFrame: 30 months
measure: Treatment-related adverse events are assessed by CTCAE v4.0.
timeFrame: acute within 3 months and chronic after 3 months after radiotherapy
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Lee Jong Hoon
Study officials:
affiliation: St. Vincent's Hospital, South Korea
name: Jong Hoon Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07011251: Food Insecurity, Food as Medicine, Hypertension
Official title: Development of a User Centered Design Approach for Screening, Referral, and Enrollment in Food as Medicine Among Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Hypertension
Keywords: Food as medicine
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention consisted of allocating patients to receive either medically tailored meals or grocery Rx program based on their preferences and resource constraints.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Development of a user centered design to understand how a tailored food is medicine program based on user preferences and needs improves engagement and clinical outcomes. The study will examine how patients, screened either face to face or through automated for food insecurity, engage in a food is medicine program over 12-weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Hypertension in last 12 months
* Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
* English or Spanish speaking
* No plans to move from the area for at least 1 year
* Willing and able to accept text messages
* Free living to the extent that participant has control over dietary intake
* Willing and able to provide written informed consent and participate in all study activities.

Exclusion Criteria:

* Participant in weight research intervention in last 12 months
* Considering bariatric surgery in the next year or prior bariatric surgery
* Lack of safe, stable residence and ability to store meals
* Lack of telephone which can receive text messages
* Pregnancy/breastfeeding or intended pregnancy in the next year
* Known drug or alcohol misuse in the past 2 years

Primary outcomes:
measure: Change systolic blood pressure
timeFrame: Baseline and week 12
measure: Change diastolic blood pressure
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change in Dietary Intake
timeFrame: Baseline and week 12
measure: Change in Nutrition Security
timeFrame: Baseline and week 12
measure: Change in food insecurity
timeFrame: Baseline and week 12
Other outcomes:
measure: Number of food insecure participants identified from automated screening
timeFrame: Baseline
measure: Number of participants enrolling in FIM from automated screening
timeFrame: 7 days
measure: Number of food insecure participants identified from face to face screening
timeFrame: Baseline
measure: Number of participants enrolling in FIM from face to face screening
timeFrame: 7 days
Locations:
city: Floyd
country: United States
facility: Appalachian Regional Healthcare
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Alison Gustafson, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References: