louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04715360: Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
Official title: Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Covid19
Sars-CoV-2 Infection
ARDS, Human
Severe covid19
Keywords: aaPRP
severe COVID-19
platelet-rich plasma
SARS-CoV-2
autologous
Lead sponsor: Hayandra Peduli Foundation
Sponsor class: OTHER
Collaborators: name: Koja Regional Public Hospital
First posted: 2021-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The positive cases of coronavirus disease-2019 (COVID-19) in Indonesia has been increasing rapidly since the first case found in March 2020 to date. Coronavirus 2 (SARS-CoV-2) virus disrupts human normal immune system resulting in uncontrolled inflammatory response. Based on our research and experience in doing cell therapy for 9 years, activated platelet-rich plasma (PRP) produces anti-inflammatory effects in inflammatory condition that is beneficial for tissue regeneration. In this study, we aimed to evaluate the potential of autologous activated platelet-rich plasma (aaPRP) and the outcomes for treating severe Coronavirus Disease-2019 (COVID-19) patients in Intensive Care Unit (ICU).

Detailed description: PRP decreases IL-1β, IL-6, IL-8, and TNFα inflammatory genes expression while also reduces IL-1β and TNFα inflammatory cytokines production. PRP has also been showed to contain interleukin 1 receptor antagonist (IL-1RA), an anti-inflammatory cytokines that suppress IL-6 secretion.

Eligibility criteria: Inclusion Criteria:

* severe covid-19 patient in ICU

Exclusion Criteria:

* CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer

Primary outcomes:
measure: Effect of aaPRP on pro-inflammatory cytokines plasma level (IL-6, IL-1B, TNFa, IFN gamma, MCP-1) before and after intervention compared to control.
timeFrame: 6 days
measure: to evaluate the change of Effect of aaPRP on anti-inflammatory cytokines plasma level (IL-1RA, IL-4, IL-10) before and after intervention compared to control.
timeFrame: 6 days
measure: Effect of aaPRP on overall adverse event related to the treatment.
timeFrame: 6 days
measure: Effect of aaPRP on CRP level before and after intervention compared to control.
timeFrame: 6 days
Secondary outcomes:
measure: Effect of aaPRP on Thorax X-ray image pre and post intervention between control and aaPRP-treated group
timeFrame: 6 days
measure: Effect of aaPRP on duration of hospitality of patient compared to control
timeFrame: 6 days
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Koja Regional Public Hospital
state: DKI Jakarta
Study officials:
affiliation: Koja Regional Public Hospital
name: Louis Martin Christoffel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00394160: Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)
Official title: A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 1 to 3 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchiolitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to \< 3 months of age with bronchiolitis.


Eligibility criteria: Inclusion Criteria :

* Active bronchiolitis and a history of bronchiolitis and asthma-like symptoms.

Exclusion Criteria :

* Anemia or history of any significant illness that will pose additional risk to the patient.

Primary outcomes:
measure: To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months.
Secondary outcomes:
measure: To estimate the single-dose population pharmacokinetics, (maximum plasma concentration, time to maximum plasma concentration, and apparent half-life) of montelukast 4-mg oral granules in children aged 1 to 3 months.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kearns GL, Lu S, Maganti L, Li XS, Migoya E, Ahmed T, Knorr B, Reiss TF. Pharmacokinetics and safety of montelukast oral granules in children 1 to 3 months of age with bronchiolitis. J Clin Pharmacol. 2008 Apr;48(4):502-11. doi: 10.1177/0091270008314251. Epub 2008 Feb 22.
Clinical trial NCT04538560: Preimplantation Genetic Testing for Aneuploidy of Polar Bodies
Official title: Preimplantation Genetic Testing for Aneuploidy by Next-generation Sequencing of Polar Bodies in Advanced Maternal Age With Poor Ovarian Responders: a Randomized Clinical Trial (Preliminary Experiments)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subfertility
Keywords: poor ovarian respond，
advanced age
Preimplantation Genetic Testing
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 36
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to randomly group the patients with advanced maternal age and poor ovarian response, and the study group will undergo polar body biopsy, and the next-generation sequencing(NGS) technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores. In the control group undergo routine culture and the transfer priority is determined according to the morphological score only. The transfer of frozen embryos at the cleavage or blastocyst stage was permitted. Cumulative live birth rate, miscarriage rate and time required to obtain a live birth up to two ovulatory cycles in a year.


Eligibility criteria: Inclusion Criteria:

* patients between their 36th and 42st birthdays;
* absence of any type of genetic abnormality in the patient's personal and family history;
* MⅡ oocytes: 2-9 .

Exclusion Criteria:

* treatment involving donor oocytes;
* any type of genetic abnormality or family history of genetic abnormality in subject or partner;
* with assisted reproductive technology and pregnancy contraindications and with diseases that have a definite effect on pregnancy;
* poor embryo quality in previous cycles;
* Preimplantation genetic testing for aneuploidy(PGT-A) cycles;
* MⅡ oocytes ≥10 or ≤ 1;
* three or more previous failed IVF or Intracytoplasmic sperm injection(ICSI) cycles.

Primary outcomes:
measure: Cumulative live birth rate
timeFrame: 22 months
Secondary outcomes:
measure: abortion rate
timeFrame: 22 months
measure: time required to obtained a live birth
timeFrame: 22 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive and Genetic Hospital of Citic-xiangya
state: Hunan
Study officials:
References:
Clinical trial NCT01159860: Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
Official title: Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seborrheic Keratosis
Keywords: seborrheic keratoses
cryosurgery
curettage
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2010-07-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Seborrheic keratoses (SK's) are very common, but harmless skin lesions that commonly appear during adult life. Patients with seborrheic keratoses frequently desire treatment due to symptoms of itching and irritation or for cosmetic purposes. Seborrheic keratoses can be easily removed and have been treated in a number of different ways. Two of the simplest and most successful ways to remove seborrheic keratoses are cryosurgery and curettage.

The investigators are conducting this study to see which of these two treatments has the best result.

Approximately 24-30 people will take part in this research study at the Hershey Medical Center.


Eligibility criteria: Inclusion Criteria:

* have at least 1 seborrheic keratosis on each side of his/her trunk or proximal extremities.
* be able to understand the consent form and evaluation of treatment questionnaire.

Exclusion Criteria:

* Children \<18 are excluded from this study based on their inability to independently complete the informed consent and research associated questionnaire.

Primary outcomes:
measure: Partial or complete resolution of treated lesion.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Lance D. Wood, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brodsky J. Management of benign skin lesions commonly affecting the face: actinic keratosis, seborrheic keratosis, and rosacea. Curr Opin Otolaryngol Head Neck Surg. 2009 Aug;17(4):315-20. doi: 10.1097/MOO.0b013e32832d75e3.
citation: Herron MD, Bowen AR, Krueger GG. Seborrheic keratoses: a study comparing the standard cryosurgery with topical calcipotriene, topical tazarotene, and topical imiquimod. Int J Dermatol. 2004 Apr;43(4):300-2. doi: 10.1111/j.1365-4632.2004.02282.x.
Clinical trial NCT02037360: Mobile Mindfulness Training for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking
Cessation
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 1251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training smartphone application on smoking cessation in smokers ages 18 to 65 years.

Detailed description: In this study, a pilot phase will be carried out first to test feasibility and engagement of the tested intervention. Then in the randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains mindfulness for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.

Eligibility criteria: Inclusion Criteria:

Participants must be (a) 18-65 years of age; (b) smoke 5+ cigarettes/day, (c) \< 3 months abstinence in the past year; (d) have a smartphone; and motivated to quit smoking.

Exclusion Criteria:

There are no exclusion criteria. We aim to recruit a heterogeneous group, representative of the general population.

Primary outcomes:
measure: Point prevalence abstinence at 6 months
timeFrame: 6 months after beginning treatment
Secondary outcomes:
measure: Point prevalence abstinence at 3 months
timeFrame: 3 months after beginning treatment
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts, Worcester
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Judson Brewer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
Clinical trial NCT05798260: T-Cell Mitochondrial Respiration Response to Ketone Monoester Supplement in Healthy Volunteers and COVID-19
Official title: Intensive Care Unit (ICU) Biospecimen and Data Repository
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Keywords: mitochondria
ketone monoester
seahorse
ketoneaid
SRC
FCCP
ECAR
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted at Duke Hospital Medical and Surgical ICU with COVID-19 manifested with ARDS and on the ventilator

Brief summary: T-Cell Mitochondrial Respiration Response to Ketone monoester (Ketoneaid) in Healthy Volunteers and COVID-19


Eligibility criteria: Inclusion Criteria:

COVID-19 with ARDS and on the ventilator

Exclusion Criteria:

* Pregnant
* \<18 years
* Steroid use

Primary outcomes:
measure: Spare Respiratory Capacity (SRC)
timeFrame: through study completion, an average of 2 months
measure: Basal Respiration
timeFrame: through study completion, an average of 2 months
measure: ATP production-coupled Respiration
timeFrame: upon admission
measure: Maximal Respiration
timeFrame: upon admission
measure: Non-Mitochondrial Respiration
timeFrame: through study completion, an average of 2 months
Secondary outcomes:
measure: Oxygen Consumption Rate (OCR)
timeFrame: through study completion, an average of 2 months
measure: extracellular acidification rate (ECAR)
timeFrame: through study completion, an average of 2 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Christina Barkauskas
state: North Carolina
Study officials:
affiliation: Research Director Duke Medical ICU
name: Christina Barkauskas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04650360: Postoperative Intervention Educational Program on the Quality of Life of Patients With Hip Fracture
Official title: Impact of a Postoperative Intervention Educational Program on the Quality of Life of Patients With Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Quality of Life
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 224
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to determine the impact of a postoperative educational intervention program on the health-related quality of life (HRQoL) of patients with hip fracture using a controlled clinical trial in a randomized, multicenter study. A total of 224 patients will be recruited, 102 patients from trauma units at the two University Hospitals of the province of Cáceres will receive the educational program, whereas 122 will not. Patients will consecutively included in either an intervention or a control group. Patients from the intervention group reill eceive an educational program during admission and the postoperative period. Patients from the control group will not receive any educational program. These patients will manage according to routine protocols.

Detailed description: This study will be perform by Spanish nurses.

Eligibility criteria: Inclusion criteria:

* Patients over 65 years of age
* Diagnosis of hip fracture
* Previous urgent surgical intervention for surgical fixation of the fracture

Exclusion criteria:

* Cognitive impairment
* Terminal situation

Primary outcomes:
measure: Quality of life assesment by
timeFrame: 12 months
Secondary outcomes:
measure: Functional dependence (basic activities of daily living )assesment by
timeFrame: 12 months
Other outcomes:
Locations:
city: Cáceres
country: Spain
facility: Sergio Rico Martin
Study officials:
affiliation: Nursing and Occupational Therapy College. University of Extremadura
name: Fidel Lopez Espuela, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03885960: Perthes Disease in Norway
Official title: A Prospective Nationwide Study of Perthes' Disease in Norway: Functional and Radiographic Outcomes at a Mean Follow-up of Twenty Years
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Legg Calve Perthes Disease
Keywords: Hip
function
quality of life
osteoarthritis
Perthes
LCPD
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sophies Minde Ortopedi
First posted: 2019-03-22
Enrollment: 216
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients which have been diagnosed with Perthes disease in between 1996 and 2000 in Norway were registered and follow at least 5 years after diagnosis. All hospitals throughout Norway with orthopaedic service were included in the registration. Our study is a 20 years follow-up of the original study.

Brief summary: Calvé-Legg-Perthes disease (CLP) is a hip disease in children whose femoral head becomes completely or partially necrotic. The disease is most common in five-six years of age. The femoral head is gradually deformed during the active stages of the disease (5-7 years). By healing, the hip joint shape will vary from an approximately normal joint to pronounced changes, the hip joint will be irregular. Such a hip joint is available for osteoarthritis. The purpose of this study is to map the function of the hip, the patient's quality of life and especially the risk factors that affect the outcome of the previous CLP. A nationwide prospective study of CLP was conducted between 1996 and 2000. All children with newly diagnosed Perthes disease (425) were registered. The current study will follow up all these patients with an average follow-up of 20 years. Radiological endpoints are evidence of hip osteoarthritis. Patient-reported outcomes (PROMS) should illuminate the function of the hip and quality of life.


Eligibility criteria: Inclusion Criteria

- Subject was diagnosed with Perthes disease between 1996 and 2000 in Norway

Exclusion Criteria:

* Death upon follow up
* Other skeletal dysplasia
* Patient not able to give consent,

Primary outcomes:
measure: Hip osteoarthritis
timeFrame: an average of 20 years follow-up
measure: Hip function
timeFrame: an average of 20 years follow-up
Secondary outcomes:
measure: Hip ROM
timeFrame: an average of 20 years follow-up
measure: Gluteal muscle strength
timeFrame: an average of 20 years follow-up
measure: Hip strength
timeFrame: an average of 20 years follow-up
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital - Rikshospitalet
state: Sognsvannsveien 20
Study officials:
affiliation: Oslo University Hospital
name: Stefan Huhnstock, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06133660: Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular
Official title: Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aqueous Tamponade
Cataract
Keywords: aqueous tamponade
cataract
lens thickness
axial length
pars plana vitrectomy
Lead sponsor: Second Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 21
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergoing vitrectomy for diabetic retinopathy, epiretinal membranes, macular hole, retinal detachment, and other diseases, or underwent vitreous silicone oil tamponade and vitreous silicone oil removal due to various causes

Brief summary: To observe the effects of vitreous cavity Balanced salt solution (BSS) tamponade on the state of the lens and related parameters of the eye, and whether the changes of the above parameters are correlated with age, gender, diabetes or not, etc., so as to provide references for the diagnosis and treatment of related diseases and scientific research.


Eligibility criteria: Inclusion Criteria:

* ① Patients undergoing vitrectomy for diabetic retinopathy, epiretinal membranes, macular hole, retinal detachment, and other diseases;

  * Patients who underwent vitreous silicone oil tamponade and vitreous silicone oil removal due to various causes; ③ Intraoperative BSS was used for fill the vitreous cavity; ④ Before treatment, inform the patient that the clinical data may be used in clinical research, and the patient and his family are informed and sign the informed consent.

Exclusion Criteria:

* ① The operation eye was intraocular lens or cataract extraction during operation; ② Suspensory ligament relaxation or rupture, ciliary body detachment or transaction, lens dislocation, endophthalmitis, traumatic cataract;

  * intraoperative lens injury; ④ patients who refused to participate in the study.

Primary outcomes:
measure: degree of lens opacity
timeFrame: 1 year
measure: lens thickness
timeFrame: 1 year
Secondary outcomes:
measure: anterior chamber depth
timeFrame: 1 year
measure: axial length
timeFrame: 1 year
Other outcomes:
Locations:
city: Changchun
country: China
facility: The Second Hospital of Jilin University
Study officials:
References:
Clinical trial NCT01409460: Obturator Nerve Block With Femoral and Sciatic Block
Official title: Is an Obturator Nerve Block Required for Every Patient Having Total Knee Arthroplasty With Femoral and Sciatic Nerve Block?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block; Pain Medication
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how many patients require the addition of the obturator nerve block in the recovery room after the total knee surgery. Also to study the efficacy of blocking the obturator nerve in controlling their knee pain.


Eligibility criteria: Inclusion Criteria:

* total knee replacement

Exclusion Criteria:

* Hisory of neurologica disease, diabetes, pregnancy, neuropathy

Primary outcomes:
measure: To assess the use of obturator Nerve block for patients undergoing total knee arthroplasty
timeFrame: 15 minutes in recovery room post operatively
Secondary outcomes:
measure: Pain medication use intra-operatively and in the recovery room after surgery. Pain scores in recovery room.
timeFrame: During surgery and until discharge from recovery room.
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
Study officials:
References: