louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02886975: Effects of Low Protein Diet in Preventing the Progression of Chronic Kidney Disease(CKD)---a Prospective Study
Official title: Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency, Chronic
Keywords: Renal Insufficiency, Chronic
Diet, Protein-Restricted
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (CKD , stage 2 to 5).

Detailed description: Dietary protein restriction represents a basic therapeutic approach in chronic kidney disease(CKD), by reducing the accumulation of nitrogen catabolic substances, and by delaying the progress of CKD and proteinuria, but the effects of the low protein diet on renal failure progression rate remain to be determined.The aim of this study is to evaluate the efficacy of low protein diet and α-keto acid tablet in retard the progress of CKD. This is a prospective study, 100 patients who meet inclusion and exclusion criteria will be included. The changes of glomerular filtration rate in CKD and time to renal replacement will be evaluated after 1 year treatment.

Eligibility criteria: Inclusion Criteria: Patients with chronic kidney disease in stage 2 to 5 (GFR\<60 ml/min/1.73m2) receiving conservative treatment for CKD

Exclusion Criteria: None

Primary outcomes:
measure: changes in glomerular filtration rate
timeFrame: 1 year
Secondary outcomes:
measure: Compliance to diet
timeFrame: 1 year
measure: Nutritional status
timeFrame: 1 year
Other outcomes:
Locations:
city: Changsha
country: China
facility: the Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: specify unaffiliated
name: Min Liu, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05709275: Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation
Official title: Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypoplastic Left Heart Syndrome
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with HLHS treated surgically and followed medically at the IRCCS Policlinico San Donato

Brief summary: This project has several objectives ranging from clinical data analysis to computational simulations as listed below:

1. Retrospective review of all patients with HLHS treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to assess the SEVR after each step of Norwood palliation to analyze its influences on:

   * Mortality;
   * Occurrence of adverse events;
   * Outcome of the three-staged palliation;
2. Creation of a prospective registry that will enroll all patients surgically treated for HLHS at the IRCCS Policlinico San Donato.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato.

Exclusion Criteria:

* Patients with any type of atrioventricular discordance.
* Pediatric patients (age ≤18 years) with the diagnosis of hypoplastic left heart syndrome who underwent the Norwood palliation at the IRCCS Policlinico San Donato before March 2019.

Primary outcomes:
measure: Mortality during the hospital stay and after the discharge
timeFrame: 5 year
Secondary outcomes:
measure: Number of adverse events registered during the follow-up.
timeFrame: 5 year
Other outcomes:
measure: Number of adverse events at the three-staged palliation (short and long-term mortality)
timeFrame: 5 year
Locations:
city: San Donato
country: Italy
facility: IRCCS Policlinico San Donato
state: Milano
Study officials:
References:
Clinical trial NCT01320475: Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine
Official title: Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Thoracic Surgery
Keywords: thoracic epidural analgesia
epidural opioid
ketamine
adverse effect
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic and an opioid are generally associated to produce an epidural analgesia. However, opioid epidural administration is frequently associated with adverse effects as nausea, vomiting, urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an effective analgesic.

The purpose of the study is to compare the epidural administration of levobupivacaine and sufentanil or the epidural administration of levobupivacaine associated with the iv administration of ketamine.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 75 yrs
* class ASA I, II or III
* lung surgery

Exclusion Criteria:

* Contra-indication to the achievement of epidural analgesia
* Preoperative chronic pain,
* Contra-indication to ketamine
* Hypersensitivity to ketamine or any excipients
* Uncontrolled hypertension,
* Stroke
* Heart failure
* Hepatic porphyria
* Contra-indication to sufentanil
* Hypersensitivity to sufentanil, opioids or any excipients
* Treatment with an opioid agonist-antagonist,
* Contra-indication to levobupivacaine
* Hypersensitivity to levobupivacaine, local anesthetics of the amide or any excipients
* Hypotension, shock

Primary outcomes:
measure: Occurrence of an adverse event due to the analgesic protocol
timeFrame: one week
measure: Efficacy of the analgesic regimen
timeFrame: third postoperative day
Secondary outcomes:
measure: postoperative rehabilitation
timeFrame: two weeks
measure: postoperative complications (pulmonary, others)
timeFrame: one month
measure: length of stay
timeFrame: one month
measure: patient's satisfaction
timeFrame: sortie de l'hopital
measure: Occurence of a chronic pain
timeFrame: end the first postoperative year
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References:
Clinical trial NCT05915975: Integrated Behavioral Healthcare for Youth With Type 1 Diabetes
Official title: Integrated Behavioral Healthcare for Low-Income Ethnic Minority Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to understand how behavioral health care that is coordinated with diabetes medical care compared with behavioral care that is provided in the community (and therefore not coordinated with diabetes medical care).


Eligibility criteria: Inclusion Criteria:

1. Type 1 Diabetes diagnosed for one year or more
2. Latino or Black ethnicity/race
3. Speak and read English or Spanish
4. Eligibility for Medicaid

Exclusion Criteria:

1. Significant developmental disability
2. Serious psychiatric disorder
3. Another serious chronic illness

Primary outcomes:
measure: Change in Glycemic Control
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Change in Diabetes Self-Management
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Univeristy of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Luiza V Mali, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01264575: ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty
Official title: ED50 and ED95 of Intrathecal Bupivacaine With or Without Epinephrine for Total Knee Replacement Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Total Knee Replacement Arthroplasty
Keywords: spinal anesthesia
intrathecal bupivacaine
epinephrine
ED50
ED95
Lead sponsor: Seoul Medical Center
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 162
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This prospective randomized double-blind dose-response study is aimed to investigate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine 100 mcg for total knee replacement arthroplasty.

Detailed description: Patients undergoing total knee replacement arthroplasty are randomly assigned to six bupivacaine dose group (6, 7, 8, 9, 10, 11 mg). Combined spinal-epidural anesthesia would be performed. The dose would be considered as successful if no epidural supplement was required during surgery. A probit analysis will be performed to calculate the ED50 and ED95 of intrathecal bupivacaine with or without epinephrine for total knee replacement arthroplasty.

After these measurements, ED50 and ED95 of bupivacaine with epinephrine would be compared with those without epinephrine.

Eligibility criteria: Inclusion Criteria:

* The patients with ASA class I or II scheduled for total knee replacement surgery

Exclusion Criteria:

* Patients with previous spine surgery, diabetic and other neuropathy, skin infection at the site of injection, allergy to bupivacaine and other common contraindications for spinal anesthesia were excluded from this study.

Primary outcomes:
measure: the success of anesthesia
timeFrame: during the surgery (average two hours)
Secondary outcomes:
measure: Adverse effects of the various intrathecal bupivacaine dose
timeFrame: during surgery (average two hours)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
Study officials:
affiliation: Seoul Medical Center
name: Won Ho Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05212675: Short Daily Versus Conventional Hemodialysis for COVID-19 Patients
Official title: Short Daily Versus Conventional Hemodialysis for COVID-19 Patients: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Dialysis
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of dialysis patients involved with COVID-19 with short daily hemodialysis has been supposed to improve short term outcome. It is unclear if short daily dialysis would optimize mortality or ICU admission in routine dialysis patients with COVID-19.

Also the potential variants according with worse outcomes remain to be fully elucidated.

Detailed description: investigators undertook a randomized trial in ESRD patients infected with COVID-19 to determine: 1) if short-daily hemodialysis is associated with a reduction in mortality and ICU admission in one weak period and; 2) the potential effective variants in worst outcome. . Paperwork for the trial was submitted to the shaheed beheshti university of medical sciences in June 2021 for registration . The protocol for this trial and supporting CONSORT checklist are available. The SBMU Ethics Board approved the study and all amendments. The study was conducted according to the Declaration of Helsinki.

Eligibility criteria: Inclusion Criteria:

* ESRD patients \>3months on hemodialysis admitted for COVID-19

Exclusion Criteria:

* ESRD patients \<3 months on hemodialysis infected with COVID-19

Primary outcomes:
measure: Mortality
timeFrame: From date of randomization until the date of first documented progression or date of death
measure: ICU add
timeFrame: From date of randomization until the date of first documented progression or date of death
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Nooshin Dalili
Study officials:
affiliation: SBMU
name: Nooshin Dalili, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06708975: Effect of Insulin Therapy by Ultrasonography in Wound Healing of Chronic Diabetic Patients
Official title: Effect of Transdermal Insulin Therapy by Ultrasonographic in Wound Healing of Chronic Diabetic Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes mellites, Insulin Phonophoresis
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of the study is to determine the effect of transdermal application of insulin therapy by phonophoresis in wound healing in diabetic patients the main question of the study: is insulin phonophoresis is effective in accelerating healing in patients with diabetes mellites? 40 patients will be randomly assigned to two groups group A will receive insulin phonophoresis plus hyper polarized laser therapy and standard wound cleaning and dressing three times weekly over four weeks.

Group B will receive hyper polarized laser therapy and standard wound cleaning and dressing three times weekly over four weeks.

Detailed description: DIMST scale ( as an acronym from the initial domains of depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunneling/undermining) will be used for assessment.

MANOVA will be used for statistical analysis between group comparison

Eligibility criteria: Inclusion Criteria:

* patients will be included if they are free from any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.

Exclusion Criteria:

patients will be excluded if they have any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.

Primary outcomes:
measure: DMIST scale which is a valid and reliable scale for measuring depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunneling/undermining.
timeFrame: before first session and at the end of the treatment program (four weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05098275: Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy Subjects at Fed State
Official title: An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5210 10/500mg in Healthy Subjects at Fed State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-28
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Phamacokinetics and safety profiles of DA-5210 10/500mg in Healthy subjects at Fed State


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History

Primary outcomes:
measure: AUCt
timeFrame: pre-dose~48 hours post-dose
measure: Cmax
timeFrame: pre-dose~48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
References:
Clinical trial NCT01654575: Methotrexate in Symptomatic Knee Osteoarthritis
Official title: Randomized Controlled Trial Using Methotrexate for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Methotrexate
Knee Osteoarthritis
Synovitis
Pain reduction
Function scores
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 88
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic criteria of primary knee OA with knee pain, were included in this study.Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and secondary outcome measures included improvements in physical function scores.There was a statistically significant reduction in pain and improvement in function in the MTX group compared to the placebo group at 16 weeks.


Eligibility criteria: Inclusion Criteria:

* primary knee osteoarthritis
* pain not responding to the usual therapy
* synovitis

Exclusion Criteria:

* any other inflammatory conditions,
* hepatic and renal insufficiency

Primary outcomes:
measure: Pain reduction
timeFrame: 4 months
measure: Pain reduction
timeFrame: 16 weeks
Secondary outcomes:
measure: Improvement in physical function scores
timeFrame: 4 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, University of Alexandria
Study officials:
affiliation: University of Alexandria
name: Anna Abou-Raya, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02288975: Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study
Official title: The Effect of Early Cytokine Absorption on the Systemic Inflammatory Response Syndrome and Organ Dysfunction in the First 48 Hours of Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Septic Shock
Keywords: hemoadsorption
extracorporeal blood purification
CytoSorb
hemofiltration
SIRS
sepsis
septic shock
membranes
ICU
dialysis
adsorption
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients with septic shock of medical origin

Brief summary: The aim of the study is to investigate the effect of CytoSorb® treatment within the first 48 hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as monitored by leukocyte activation and inflammatory mediators.


Eligibility criteria: Inclusion Criteria:

* Signs of hypoperfusion: serum lactate \>2 mmol/L, low central venous oxygen saturation (ScvO2) (\<70%) or high ScvO2 (\>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 \>6 mm Hg)
* Hemodynamic support with vasopressors
* Procalcitonin level ≥ 3 ng/ml
* Invasive hemodynamic monitoring
* Written informed content

Exclusion Criteria:

* Patients under 18 years
* Pregnancy (bHCG test positivity)
* Surgical intervention in context with the septic insult
* New York Heart Association IV heart failure
* Acute coronary syndrome
* Need for acute or chronic hemodialysis
* Acute haematological malignancies
* Cardiogenic shock
* Post cardiopulmonary resuscitation care
* Immunosuppression, systemic steroid therapy (\>10mg prednisolon/day)
* Human immunodeficiency virus infection (HIV) and active AIDS
* Patients with donated organs
* Thrombocytopenia (\<20.000/ml)
* More than 10%-of body surface area with third degree burn

Primary outcomes:
measure: Cytokine response
timeFrame: First 48 hours of septic shock
measure: Organ dysfunctions
timeFrame: First 48 hours of septic shock
Secondary outcomes:
measure: Leukocyte function
timeFrame: First 48 hours of septic shock
measure: Microcirculation
timeFrame: First 48 hours of septic shock
Other outcomes:
measure: Length of intensive care unit stay,
timeFrame: First 48 hours of septic shock
measure: Length of hospital stay
timeFrame: First 48 hours of septic shock
measure: Mortality
timeFrame: First 48 hours of septic shock
Locations:
city: Szeged
country: Hungary
facility: Department of Anaesthesiology and Intensive Therapy
state: Csongrád
Study officials:
References:
citation: Hawchar F, Laszlo I, Oveges N, Trasy D, Ondrik Z, Molnar Z. Extracorporeal cytokine adsorption in septic shock: A proof of concept randomized, controlled pilot study. J Crit Care. 2019 Feb;49:172-178. doi: 10.1016/j.jcrc.2018.11.003. Epub 2018 Nov 10.