louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05546489: Proof-of-concept Lymfif
Official title: A Proof-of-concept Study of Lymfit: A Personalized, Virtual Exercise Intervention to Improve Health Outcomes in Lymphoma Survivors in the Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: Quality of Life
cancer survivors
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This proof-of-concept study was to explore the implementation feasibility to deliver the Lymfit intervention to participants remotely during the pandemic.


Eligibility criteria: Inclusion Criteria:

* 1. previously diagnosed with lymphoma
* 2. have completed chemotherapy
* 3. had access to a smart phone or an electronic device (e.g., tablet) that allowed them to attend virtual meetings and install the Fitbit application

Exclusion Criteria:

-1. have any contra-indications to performing physical activities as determined by the hematologist

Primary outcomes:
measure: Quality of Life : changes from baseline to post-intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Fear of Cancer Recurrence : changes from baseline to post-intervention
timeFrame: 12 weeks
measure: Fear related to the pandemic : changes from baseline to post-intervention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT02565589: Hyporesponsiveness of Natural Killer Cells and a Dysfunctional Inflammatory Response in Critically Ill Patients
Official title: Hyporesponsiveness of Natural Killer Cells and a Dysfunctional Inflammatory Response in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From April 2014 to July 2015, 24 critically ill patients were enrolled in this study after admission to the ICU at Yonsei University Severance Hospital. For validation of the experimental findings, age-, sex- and BMI-matched healthy subjects were enrolled as controls among individuals seen at a health evaluation center during the same period.

Brief summary: To investigate natural killer (NK) cell activities, circulating cytokine levels and peripheral blood mononuclear cell (PBMC) cytokine production status in critically ill patients.

Detailed description: Blood samples were collected \< 24 hours after admission from 24 intensive care unit (ICU) patients and 24 age-, sex-, and body mass index (BMI)-matched healthy controls. NK cell activities, cytokine concentrations and cytokine production by PBMCs and lipopolysaccharide (LPS)-stimulated PBMCs were measured.

Eligibility criteria: Inclusion Criteria:

* ICU patients
* For healthy controls: nondiabetic and nonobese subjects

Exclusion Criteria:

* For healthy controls: diabetes; history/presence of significant metabolic disease; pregnancy or breast-feeding; acute or chronic infection; liver disease; kidney disease; gastrointestinal disease; subjects taking any drugs or supplements

Primary outcomes:
measure: NK cell activity
timeFrame: Baseline
Secondary outcomes:
measure: IL (Interleukin)-12
timeFrame: Baseline
measure: hs-CRP (high-sensitivity C-reactive protein)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Kim M, Kim M, Jeong H, Chae JS, Kim YS, Lee JG, Cho Y, Lee JH. Hyporesponsiveness of natural killer cells and impaired inflammatory responses in critically ill patients. BMC Immunol. 2017 Dec 8;18(1):48. doi: 10.1186/s12865-017-0231-y.
Clinical trial NCT03534089: Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia
Official title: Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Lead sponsor: Beingmate Baby & Child Food Co Ltd .
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 135
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A multi-center,randomized,double-blind,controlled clinical trial was used to investigate the effectiveness of the treatment of infant iron deficiency anemia by taking ferralia and different contents lactoferrin.

Detailed description: 5-9 months old infants with iron deficiency anemia were randomly divided into three groups. On the basis of giving the same dose of ferralia,three different levels lactoferrin infant formula were intervened 3 months respectively,and evaluate the clinical effect.

Eligibility criteria: Inclusion Criteria:

* Full term,healthy infants at 37-42 weeks of gestational age
* 5-9 months old infants were diagnose as iron deficiency anemia
* Accepting bottle feeding

Exclusion Criteria:

* Hb\<60 g/L
* Other microcytic, hypochromic anemia

Primary outcomes:
measure: Changes of Hb concentration(g/L)
timeFrame: Change of Hb concentration from baseline at 1 month and 3 months.
Secondary outcomes:
measure: Change of body weight (kilograms)
timeFrame: Changes of body weight from baseline at 1 month and 3 months.
measure: Change of body length (meters)
timeFrame: Changes of body weight from baseline at 1 month and 3 months.
measure: Change of head circumference (millimeters)
timeFrame: Changes of body weight from baseline at 1 month and 3 months.
measure: Change of serum ferritin concentration (μg/L)
timeFrame: Changes of serum iron concentration from baseline at 3 months.
measure: Change of serum transferrin receptor concentration(mg/L)
timeFrame: Changes of serum transferrin receptor concentration from baseline at 3 months.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
Study officials:
References:
Clinical trial NCT04628689: Quadratus Lumborum Block by Paraspinous Sagittal Shift Approach With Different Concentrations Of Bupivacaine in Hip Surgeries
Official title: Comparison Of The Analgesic Efficacy Of Quadratus Lumborum Block By Paraspinous Sagittal Shift Approach With Different Concentrations Of Bupivacaine in Hip Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hip Surgeries
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 5
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the optimum concentration of bupivacaine in Paraspinous Sagittal Shift Approach for Quadratus Lumborum Block in hip Surgeries

Detailed description: With the patient in the lateral decubitus and the block side independent, a curvilinear ultrasound transducer (2-5 MHz) will be directed caudally in a sagittal plane 3-4 cm lateral to the lumbar spinous process of L4, which is almost opposite to the iliac crest, producing a longitudinal scan of the lumbar paravertebral region; and thus identifying the transverse processes of L3 and L4, with PM muscle in-between and erector spinae muscle posteriorly.

The probe is shifted slowly to the lateral side until the transverse processes disappear and the QL muscle is evident in its long axis attached caudally to the iliac crest with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, QL, and PM muscles respectively. After subcutaneous local infiltration with lidocaine at the cephalic end of the probe, the block needle is advanced in a cephalo-caudal direction, through the erector spinae and QL muscles, until it pierces the epimysium of the QL. LA is injected anterior to the QL muscle, observing its spread in a caudal direction towards the iliac crest between the QL and psoas muscles

Eligibility criteria: Inclusion Criteria:

* ASA I and II undergoing hip surgery.

Exclusion Criteria:

* Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy) allergic reaction to drugs. opium addiction, any drug or substance abuse

Primary outcomes:
measure: time to first request of analgesics
timeFrame: Postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Benisuef univercity
state: Benisuef
Study officials:
References:
Clinical trial NCT00001489: Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism
Official title: The Effect of Vigabatrin on Cerebral Blood Flow and Glucose Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Epilepsy, Complex Partial
Keywords: Cerebral Metabolism
Complex Partial Seizures
Epilepsy
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study is designed to test the effects of vigabatrin (gamma-vinyl-GABA) an experimental drug used for the treatment of epilepsy. The study will use positron emission tomography (PET scan) to detect areas of the brain receiving increased blood flow and using increased amounts of glucose. Increases in blood flow and glucose use are good indicators of brain activity.

Researchers are interested in determining the effects of Vigabatrin on brain blood flow and glucose use.

Detailed description: This double-blind placebo-controlled parallel design protocol will investigate the effects of gamma-vinyl-GABA (vigabatrin--GVG) an experimental antiepileptic drug, on cerebral glucose metabolism (LCMRglc), blood flow (CBF), and seizure frequency, in patients with uncontrolled complex partial (CPS) and secondary generalized seizures (GTCS). Positron Emission Tomography (PET) will be used to measure CBF and LCMRglc.

Eligibility criteria: Localization-related epilepsy.

Uncontrolled seizures.

Ability to tolerate tegretol monotherapy.

No systemic illness requiring drug therapy.

No illness that might be made worse by vigabatrin.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Neurological Disorders and Stroke (NINDS)
state: Maryland
Study officials:
References:
citation: Ben-Menachem E, Persson LI, Schechter PJ, Haegele KD, Huebert N, Hardenberg J, Dahlgren L, Mumford JP. The effect of different vigabatrin treatment regimens on CSF biochemistry and seizure control in epileptic patients. Br J Clin Pharmacol. 1989;27 Suppl 1(Suppl 1):79S-85S. doi: 10.1111/j.1365-2125.1989.tb03466.x.
citation: Browne TR, Mattson RH, Penry JK, Smith DB, Treiman DM, Wilder BJ, Ben-Menachem E, Napoliello MJ, Sherry KM, Szabo GK. Vigabatrin for refractory complex partial seizures: multicenter single-blind study with long-term follow-up. Neurology. 1987 Feb;37(2):184-9. doi: 10.1212/wnl.37.2.184.
Clinical trial NCT05967429: Predictors of Sorafenib Response in HCC
Official title: Predictors of Sorafenib Response in Patients With Advanced Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma
Keywords: Nutrition assessment
HCC
Sorafenib
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hepatocellular carcinoma patient receiving sorafenib

Brief summary: Evaluating the nutrition status of patients with advanced HCC who received sorafenib.

Using the pretreatment nutrition status and quality of life as predictors to sorafenib response

Detailed description: This a cross sectional study will be conducted on 100 HCC treated with sorafenib Data were gathered from medical records, including

age sex body weight and height (BMI) pre-therapy laboratory counts of white cells, neutrophils, lymphocytes, monocyte, hemoglobin and platelets; bilirubin, albumin and globulin concentration, AST, ALT, AFP, PT and CONC

Barcelona Clinic Liver Cancer Stage (BCLC) of all patients

The neutrophil-to- lymphocyte ratio (NLR) was calculated by dividing the neutrophil count by the lymphocyte count.

The platelet- to-lymphocyte ratio (PLR) was calculated by dividing the platelet count by the lymphocyte count.

Weight loss difference after treatment Portal hypertension was defined as presence of either collaterals on radiological examination, esophageal varices by upper gastrointestinal endoscopy and/or thrombocytopenia.

Quality of life assessment. QoL was assessed using FACT Hepatobiliary Symptom Index (FHSI-8) Questionnaire. QoL was assessed at base line and 3-6 months after start of treatment.

Eligibility criteria: Inclusion Criteria:

* HCC recieved sorafenib

Exclusion Criteria:

* Patient refuse to participate
* Patients recieving other treatment modalities

Primary outcomes:
measure: assessment of nutrition status
timeFrame: Augest 2023 to March 2024
measure: Predictors of sorafenib response
timeFrame: Augest 2023 to March 2024
measure: Assess the quality of life
timeFrame: Augest 2023 to March 2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: Amr Zagloul, MD
role: STUDY_DIRECTOR
affiliation: Sohag University
name: Ahmed othman, MD
role: STUDY_CHAIR
affiliation: Sohag University
name: Rafat Abd El Aal, MD
role: STUDY_CHAIR
References:
citation: Takagi K, Buettner S, Ijzermans JNM. Prognostic significance of the controlling nutritional status (CONUT) score in patients with colorectal cancer: A systematic review and meta-analysis. Int J Surg. 2020 Jun;78:91-96. doi: 10.1016/j.ijsu.2020.04.046. Epub 2020 Apr 23.
Clinical trial NCT01451944: Effect of Home Health Case Management on Asthma Morbidity
Official title: Effect of Home Health Nurse Case Management on Asthma Morbidity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Asthma
Childhood Asthma
Keywords: Asthma
Home Health Nursing
Patient education
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of our program is to evaluate the effect of home health nurse intervention and education on hospital admissions, ER utilization and asthma control of Passport asthma patients. The investigators hypothesize that case management and in home education by nurses will decrease hospitalizations and ER asthma visits and improves disease control in our population.

Our clinic population consists of primarily inner-city, low income, medicaid recipients. This population suffers from severe asthma much more than the typical pediatric population. Asthma remains the most frequent cause of hospital admission for our patient population. Home health nurse asthma education and home visits have been reported to reduce asthma triggers in the home and improve asthma control. The unique partnership between the pediatrician and the home health nurse will give us a better understanding of the health needs for this population, will improve quality of care and deliver more cost effective care.

Detailed description: Asthma patients age 3-17 enrolled in our clinic who have been seen in the ER, hospital or clinic for an asthma exacerbation will be invited to participate. Once enrolled they will have a home health nurse visit their home and provide medical assessment, asthma education and determine if the patients has all needed medications available. They enrolled patient will receive another home visit at 1, 4, and 12 months after enrollment. The medical record will be reviewed and ER visits and hospitalizations recorded.

Eligibility criteria: Inclusion Criteria:

* Children age 3-17 years with asthma who attend our clinic who present with an asthma exacerbation to the clinic, ER or hospital.

Exclusion Criteria:

* Patients with airway anomalies or tracheostomy

Primary outcomes:
measure: Decreased asthma hospitalization rates
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Children and Youth Project
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Judith A Theriot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00731744: Generation of Dendritic Cell Precursors From Cord Blood Stem Cells
Official title: Generation of Dendritic Cell Precursors From Cord Blood Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normal Full-Term Deliveries
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-08-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: There is a growing interest in generating dendritic cells (DCs) for using as vaccines. Several cytokines, especially stem cell factor (SCF) and FLT3-ligand (FL), have been identified as essential to produce large numbers of myeloid precursors and even to increase DC yield obtained by the action of granulocyte-macrophage colony-stimulating factor (GM-CSF) and tumor necrosis factor alpha (TNF-α). However, there are few studies on the effect of the early-acting cytokines, commonly used to expand CD34+ progenitor cells, on DC generation.

We have established a serious of functional analysis of maturated or immaturated DCs including surface markers screening or cytokine production. Here, we design this two-year project to evaluate the possible methodology in the generation of CD14+CD1a- and CD14- CD1a+ myeloid DC precursors from CD34+ cells. In the first year of the project, we will set up the standard protocol to generate DC precursors from cord blood stem cells. In the first step, we will isolate CD34+ cells from cord blood and amplify these cells. Purity of the CD34+ cell populations obtained will be greater than 90%. In the next step, these primary cultures of CD34+ cells will treat with early-acting cytokines such as GM-CSF and IL-4 to further induction into dendritic cells. Functional analysis of dendritic cells would be performed in this stage. In the second year of the project, we will further evaluate the induction of DCs by CD34+ stem cells could be affected by combination of mesenchymal stromal cells. These results of this research with CD34+-based DCs induction provide the basis for materials to develop the DC-based vaccine against viral and fungal infections, and might be a powerful tool in anti-tumor immunotherapy.


Eligibility criteria: Inclusion Criteria:

* Normal full-term deliveries

Exclusion Criteria:

Primary outcomes:
measure: None, we isolate stem cells from cord blood.
timeFrame: from CS operation to close
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT02681744: Sarcopenia, Obesity, and Resistance Training
Official title: Effects of Resistance Training on Sarcopenic Obesity Index in Older Women: a RCT.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Aging
Obesity
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 244
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to examine the effects of resistance training on sarcopenic obesity in older women.

Detailed description: To examine the effects of resistance training on sarcopenic obesity in older women, a representative sample of older women from Brasília, Brazil (n\>244 subjects), will be recruited and invited to undergo body composition measurement using dual-energy x-ray absorptiometry. Moreover, the Sarcopenic Obesity index and isokinetic strength evaluations will be performed. It will be a single-blind randomized, controlled 24-week clinical trial, in which experimental group will receive a progressive resistance training program, meanwhile control group will receive instructions to maintain their lifestyle habits. Randomization will be conducted by computer-generated list in blocks of 10. Additionally, body composition, strength assessment, and sarcopenic index will collected and compared after the intervention period.

Eligibility criteria: Inclusion Criteria:

* Community older women (aged between 60 and 80 years).

Exclusion Criteria:

* individuals with any metallic implant or artificial pacemaker, who had undergone hip surgery, who were unable to walk without assistance and those affected by metabolic or endocrine disorders that affect the muscular system.

Primary outcomes:
measure: Laboratorial Body Composition assessment (DXA)
timeFrame: 30 minutes
Secondary outcomes:
measure: Isokinetic peak torque of leg extension (dynamometer isokinetic)
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Faculdade de Educação Física
state: Distrito Federal
Study officials:
affiliation: University of Brasilia
name: Ricardo M Lima, PhD
role: PRINCIPAL_INVESTIGATOR
References: