louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03433508: Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock
Official title: Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock: An Open Label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 0
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: Consecutive cirrhotics who present to emergency department of ILBS with documented or suspected sepsis induced hypotension with Hb \<8 gm/dl will be randomly assigned to restrictive (Target Hb 7-8 gm/dl) to liberal (Target Hb 10-11 gm/dl) group in a 1:1 proportion At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. Enrolled patients will be given PRBC-transfusion (Not more than two units of PRBC/day) when they reach their assigned trigger value (Hb 7-8 g/dl or 10-11 g/dl ) during the entire ICU stay. All other interventions will be at the discretion of clinicians.


Eligibility criteria: Inclusion Criteria:

1. Cirrhosis with septic shock.
2. Age \>18 years

Exclusion Criteria:

1. Previous severe adverse reaction with blood products,
2. Disseminated intravascular coagulopathy
3. HCC
4. Pregnancy
5. Malignancy
6. Active gastrointestinal bleeding
7. Intracranial bleeding
8. Chronic Kidney disease with Maintenance Hemodialysis
9. Pulmonary Edema
10. Congestive Heart Failure
11. Lack of informed consent

Primary outcomes:
measure: Mortality in both groups
timeFrame: 28 dyas
Secondary outcomes:
measure: Improvement in vasopressors in both groups
timeFrame: 28 days
measure: Incidence of complications in both groups
timeFrame: 28 days
measure: Length of ICU (Intensive Care Unit) stay
timeFrame: 28 days
measure: Requirement of mechanical ventilation in both groups
timeFrame: 28 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT06129123: An Online Intervention to Reduce E-cigarette Use and Susceptibility to Smoking in Young Adults
Official title: Development of an Online, Theory-Based Intervention to Reduce E-cigarette Use and Susceptibility to Smoking in Young Adults: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: E-cigarette Use
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this intervention development and pilot clinical trial is to determine whether receiving the brief online intervention results in greater reductions in past 7-day e-cigarette use frequency and smoking susceptibility over an 8-week period compared to receiving the control condition in young adults who currently use e-cigarettes. Participants in the experimental condition will be asked to complete the 30-minute mobile-based program. Participants in the assessment-only control will be given the option to access the intervention after they complete their final survey at 8 weeks. All participants will complete our online surveys at baseline as well as 2-weeks, 4-weeks, and 8-weeks post-randomization. Researchers will compare outcomes among the intervention and control groups to determine the efficacy of the intervention.


Eligibility criteria: Inclusion Criteria:

* be between the ages of 18 to 24
* be able to read English
* report vaping at least one day per week in the past month
* report no history of cigarette use at screening and baseline.

Exclusion Criteria:

* reporting severe mental health, illicit drug use, or alcohol use disorder
* currently receiving nicotine cessation services

Primary outcomes:
measure: E-cigarette Use
timeFrame: 8 weeks
measure: Smoking Susceptibility
timeFrame: 8 weeks
Secondary outcomes:
measure: Perceived harms and benefits of vaping
timeFrame: 8 weeks
measure: Perceived harms and benefits of smoking
timeFrame: 8 weeks
measure: Motivation to vape
timeFrame: 8 weeks
measure: Motivation to smoke
timeFrame: 8 weeks
measure: Quitting vaping self-efficacy
timeFrame: 8 weeks
measure: Vaping quit attempts
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern California
name: Denise D Tran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02665923: Gastric Emptying in Neonates and Infants After Formula Feeding
Official title: Gastric Emptying in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Emptying
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 210
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be performing serial ultrasounds in total of 100 healthy newborns, and 50 4-6 months old and 50 9-12 months old infants.

Brief summary: Ultrasound imaging will be used to evaluate time for gastric emptying in healthy, fasting newborns, and infants following feeding of clear liquids and/or milk (including breast or formula).

Detailed description: The study involves serial ultrasounds over several visits. Healthy newborns in the Newborn Nursery will be recruited to conduct this study. The study will include a total of 50 healthy newborns who will be given formula feeding of known volume, and then serial ultrasound imaging of gastric antral volume will be performed until gastric emptying.

The study originally was designed to perform follow up of these newborns at two later time intervals (between ages 4-6 months, and 9-12 months). The purpose of follow-up is to evaluate whether there are age-related changes in gastric emptying. Due to the pause/suspension of research activity during the pandemic, these follow up studies of the original newborn cohort could not be completed. The protocol is thus revised as follows:

The study will recruit 50 4-6 months old and 50 9-12months old infants and perform gastric emptying serial ultrasound to evaluate if there are age-related changes in gastric emptying.

Eligibility criteria: Inclusion criteria for study cohort are pediatric patients from Allen Hospital and Morgan Stanley Children's Hospital of New York Presbyterian Hospital who are receiving feeding by formula

1. healthy full-term (postmenstrual age ≥ 36 weeks) newborns aged 0-5 days or
2. healthy infants (4-6 months old and 9-12 months old)

Exclusion criteria are individuals who have

1. newborn history of requirement resuscitation at delivery
2. newborn history of admission to the Neonatal Intensive Care Unit
3. any history of hospital admission
4. history of gastroesophageal reflux or other feeding difficulty
5. receiving any medication known to accelerate or delay gastric emptying, including but not limited to opioid-containing medications and antacids.

Primary outcomes:
measure: Gastric Antral Volumes in Newborns
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Gastric Antral Volumes in Infants
timeFrame: Up to 6 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Lena S. Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02897323: Northwest Adult Congenital Heart Disease Observatory
Official title: Northwest Inter Hospital Adult Congenital Heart Disease Observatory
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients visiting the participating centers meet the following criteria:

* Patient, male or female, aged 18 years
* with congenital heart disease operated or non-operated
* Followed by a cardiologist specializing in congenital heart disease in the inter northwest region of France

Brief summary: The incidence of congenital heart disease is about 8 per thousand live births. Thanks to advances in cardiac surgery, 90% of children born with heart defects reach adolescence and adulthood. Congenital heart defects are the leading cause of heart disease in young adults and expectant mothers in Western countries. The number of patients increases continuously as life expectancy increases. An increasing number of patients with complex heart defects survive to adulthood. The medico-surgical management of this highly specialized growing number of patients is difficult and requires a multidisciplinary collaboration. In France, an estimated 200,000 patients the number of carrier patients with congenital heart disease. Half of them will require monitoring, medical procedures, catheterizations and/or surgical re-intervention. No objective demographic data are currently available on the French patients. So, the investigators decided to set up an epidemiological project to better understand this cohort of patients. The main objective of this project is to obtain accurate epidemiological data needed to adapt the supply of care.


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, aged 18 years
* Congenital heart disease operated or non-operated
* Followed by a cardiologist specializing in congenital heart disease in the inter northwest region of France

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: patients characteristics description
timeFrame: baseline
Secondary outcomes:
measure: heart disease complications description
timeFrame: baseline
measure: complications during pregnancy description
timeFrame: baseline
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT06593223: Non-invasive Filling Pressure(NIFP) Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients
Official title: Non-invasive Filling Pressure(NIFP) Device Based on Low Frequency Heart Sound in Assessment of Congestion in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: The University of Hong Kong-Shenzhen Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen Fiber Medical Technology Co., Ltd.
First posted: 2024-09-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient visits to hospital with suspected heart failure (HF) or with history of HF were enrolled. Some of the patients were admitted to cardiology ward due to initial diagnosis of acute heart failure (AHF). Some of the patients are who make a planned visit to outpatient clinic with history of HF. All patients are over 18 years old and are willing to sign the inform consent.

Brief summary: Congestion plays a key role in heart failure (HF) trajectory .Clinical congestion refers to the signs and symptoms resulting from elevated cardiac filling pressures. Hemodynamic congestion refers to elevated cardiac filling pressures, which may occur days or weeks before the presentation of symptoms , , .

Serial assessment of congestion is required in each encounter of the HF patients, while in current clinical practice, serial assessment of congestion relies on physical examination, sometimes supported by BNP test. Both physical and BNP test are reported to be unreliable in some cases ， . Echocardiography is good tool, but it requires skilled physician to operation and is more time consuming. In general, there is unmet needs of better tools for serial assessment of congestion in HF patient management.

In this study, we aim to prospectively observe and evaluate the feasibility of using a novel non-invasive device in assessment of congestion in HF patients.


Eligibility criteria: Inclusion Criteria:

* Acute heart failure；Stabilized outpatient chronic heart failure patients；Willing to sign the inform consent

Exclusion Criteria:

* 1.Patients under 18 years old 2.Patients with congenital heart diseases (e.g., tetralogy of Fallot, atrial septal defect, Fontan disease, single chamber disease) 3.Patients with implanted artificial mechanical valves, pacemaker or ICD. 4.Patients with significant back issues that prevent them from lying supine on the bed 5.Pregnant patients 6.Patient wight under 35 kg or over 150 kg 7.Patients who are attaching to other medical device that prevent them to receive a test by the study device.

Primary outcomes:
measure: Noninvasive filling pressure testing has clinical significance consistent with NT-proBNP and CCS scores to reflect congestion in acute heart failure.
timeFrame: 2025-7-1
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Mingya Liu
state: Guangdong
Study officials:
References:
Clinical trial NCT06302023: Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor
Official title: Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnant Women Diagnosed With Threatened Preterm Labor
Keywords: DHA
threatened preterm labor
Docosahexaenoic acid
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm labor

The main questions it aims to answer are:

* Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor?
* How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups
* Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day
* Group 2 (control) Participant will not need to take a DHA

Detailed description: Threatened preterm labor is defined as regular uterine contractions occurring before 37 completed weeks of gestation, without any cervical dilation.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Between 24 wk to 34 wk of gestational age
* Pregnant women diagnosed threatened preterm labor (with no cervical change)

Exclusion Criteria:

* Fetal anomalies
* Multiple pregnancy
* Premature rupture of membrane
* Placental disorders: placenta previa, placental abruption
* Fetal growth restriction
* Pregnancy complication: gestational diabetes mellitus, Chronic hypertension
* Allergic reaction to DHA

Primary outcomes:
measure: Number of Participants with preterm birth
timeFrame: at delivery time
Secondary outcomes:
measure: Rate of low birth weight neonate
timeFrame: at delivery time
measure: Rate of Neonatal Intensive care unit admission
timeFrame: at delivery time
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: KhonKaenU
state: KhonKaen
Study officials:
References:
Clinical trial NCT00026923: A Phase II Evaluation of Telesurgery Systems
Official title: A Phase II Evaluation of Telesurgery Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Laparoscopy
Keywords: Laparoscopy
Telemedicine
Surgery
Endoscopy
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-11-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This study evaluates a system of remote supervision of laparoscopic surgery. Laparoscopic surgery is performed through small holes in the abdomen called ports. A camera is passed through one port for visualization. Laparoscopic surgery requires an assistant to hold the camera and help the operating surgeon view the surgical field. The assistant camera holder may be a surgeon or a robotic arm. The robotic arm is usually controlled by the operating surgeon. In this study, a robotic arm holding the camera will be used, and will be controlled by a surgeon outside the operating room.

Detailed description: This study evaluates a system of remote supervision of laparoscopic surgery. Laparoscopic surgery is performed through small holes in the abdomen called ports. A camera is passed through one port for visualization. Laparoscopic surgery requires an assistant to hold the camera and help the operating surgeon view the surgical field. The assistant camera holder may be a surgeon or a robotic arm. The robotic arm is usually controlled by the operating surgeon. In this study, a robotic arm holding the camera will be used, and will be controlled by a surgeon outside the operating room.

Eligibility criteria: Any patient undergoing laparoscopic surgery.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
citation: Kavoussi LR, Moore RG, Partin AW, Bender JS, Zenilman ME, Satava RM. Telerobotic assisted laparoscopic surgery: initial laboratory and clinical experience. Urology. 1994 Jul;44(1):15-9. doi: 10.1016/s0090-4295(94)80003-0.
citation: Moore RG, Adams JB, Partin AW, Docimo SG, Kavoussi LR. Telementoring of laparoscopic procedures: initial clinical experience. Surg Endosc. 1996 Feb;10(2):107-10. doi: 10.1007/BF00188353.
citation: Docimo SG, Moore RG, Adams J, Ben-Chaim J, Kavoussi LR. Early experience with telerobotic surgery in children. J Telemed Telecare. 1996;2 Suppl 1:48-50. doi: 10.1258/1357633961929259. No abstract available.
Clinical trial NCT06108323: Immediate Effects of Mental Practice and Therapeutic Exercise in Mild Smokers
Official title: Immediate Effects of Mental Practice and Therapeutic Exercise in Mild Smokers: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smokers
Keywords: smokers
therapeutic exercise
mental practice
respiratory function
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about the effects who would add mental practice based on action observation to a therapeutic exercise program in young mild smokers.

The main question it aims to answer is whether the observation of actions prior to the implementation of a therapeutic exercise session improves the response to it on respiratory, strength and muscle function variables.

Participants will be assigned to one of 2 study groups:

G1) Therapeutic exercise plus action observation training (n=20) G2) Therapeutic exercise plus sham action observation training (n=20)


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Had a pack per year index of \<5 (mild smoking index).

Exclusion Criteria:

Those who presented:

* a respiratory pathology,
* cardiac, systematic, or metabolic disease,
* history of recent surgery,
* vertebral fracture,
* or osteoarticular disorders of the spine area.

Primary outcomes:
measure: Respiratory strength
timeFrame: Preintervention and inmediately after the intervention
Secondary outcomes:
measure: Respiratory function parameters
timeFrame: Preintervention and inmediately after the intervention
measure: Physical function
timeFrame: Preintervention and inmediately after the intervention
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universitat de Valencia
Study officials:
References:
Clinical trial NCT00004323: Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aplastic Anemia
Keywords: aplastic anemia
hematologic disorders
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of California, Los Angeles
First posted: 1999-10-19
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the efficacy of related, HLA-identical bone marrow transplantation following cyclophosphamide (CTX) and antithymocyte globulin in patients with aplastic anemia.

II. Evaluate the efficacy of related, HLA-nonidentical bone marrow transplantation following CTX and total-body irradiation/total-lymphoid irradiation in patients with aplastic anemia.

Detailed description: PROTOCOL OUTLINE: Patients with HLA-identical donors receive cyclophosphamide/mesna, antithymocyte globulin (ATG), and methylprednisolone (MePRDL), followed by allogeneic marrow transplantation.

Patients with HLA-nonidentical (5/6 or 4/6) donors and those with a systemic reaction to ATG receive the same dosage of myeloablative chemotherapy and rescue. In addition, these patients are treated with total-body irradiation, total-lymphoid irradiation, and methotrexate.

All patients received MePRDL and cyclosporine for graft-versus-host prophylaxis.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Severe aplastic anemia with 2 of the following criteria: Polymorphonuclear neutrophils no more than 0.5 x 10 to the ninth/L Platelets no more than 20 x 10 to the ninth/L Reticulocytes no more than 30 x 10 to the ninth/L Hypocellular bone marrow Related donor aged 6 weeks or more, matching at least 4 of 6 HLA A, B, and DRI loci, as follows: HLA-identical family member for patients aged less than 40 years HLA-nonidentical family member for patients aged less than 55 years failing antithymocyte globulin or other immunosuppressive therapy The following eligible for transplantation as initial therapy: Patients aged less than 40 years with HLA-matched donor Patients aged 40-45 years with HLA-identical donor No neoplastic or preneoplastic evolution --Patient Characteristics-- Age: Under 40 (55 if ATG failure) Hepatic: No severe liver dysfunction Renal: No severe renal dysfunction Cardiovascular: No severe cardiac dysfunction Other: No other organ dysfunction that would compromise survival after transplant No HIV infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Center for Health Sciences
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Mary Carol Territo
role: STUDY_CHAIR
References: