louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06490549: An Epidemiological Study to Investigate the Characteristics of RSV Infection in Adult Hematopoietic Cell Transplant Recipients or Hematological Malignancies Patients in Tianjin HI (Hematology Institute)
Official title: An Epidemiological Study to Investigate the Characteristics of RSV Infection in Adult Hematopoietic Cell Transplant Recipients or Hematological Malignancies Patients in Tianjin HI (Hematology Institute)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: RSV Infection
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 500
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: adult hematopoietic stem cell transplantation (HCT) recipients OR hematological malignancies (HM) patients have new onset or worsen of respiratory signs/syndromes and presented the study site.

Brief summary: This primary objective of this study is to describe the incidence of RSV infection in adult hematopoietic cell transplant recipients OR hematological malignancies patients in Tianjin HI.


Eligibility criteria: Inclusion Criteria:

* 1) Aged ≥ 18 years old. 2) Receiving hematopoietic stem cell transplantation; OR being diagnosed with hematological malignancies (including but not limited to leukemia, lymphoma, and multiple myeloma) and receiving chemotherapy.

  3) New onset of respiratory symptoms; OR exacerbation of existing chronic respiratory symptoms (such as previously diagnosed chronic runny nose, seasonal allergies, chronic lung disease, etc.).

  4) Willing to sign an informed consent form, able to understand and willing to follow the study protocol.

Exclusion Criteria:

* Unwillingness to sign an informed consent form.

Primary outcomes:
measure: the incidence of RSV infection in adult hematopoietic stem cell transplantation (HCT) recipients OR hematological malignancies (HM) patients presenting the study site
timeFrame: 1 year
measure: the Incidence of RSV infection in adult hematopoietic stem cell transplantation (HCT) recipients OR hematological malignancies (HM) patients presenting the hospital
timeFrame: 1 year
Secondary outcomes:
measure: the clinical characteristics of RSV infection
timeFrame: 1 year
measure: Clinical outcome and relevant risk factor of RSV infection
timeFrame: 1 year
measure: Virological characteristics of RSV infection from D1 through D28, D42 or even longer
timeFrame: 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Study officials:
References:
Clinical trial NCT03197649: CO2 Laser Phototherapy for Management of Mature Burn Scars
Official title: Randomized, Prospective, Split Scar Pilot Study to Evaluate the Efficacy of CO2 Laser Phototherapy for Management of Mature Burn Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Scar
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
First posted: 2017-06-23
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study patient will have one portion of their scar, measuring 5x5 cms (or 50% of the scar, for scars smaller than 5x10 cms) left untreated at the time of the study.
Primary purpose: TREATMENT

Brief summary: Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.

Detailed description: Laser phototherapy has gained growing acceptance and popularity for management of burn scars. The most commonly used laser is the Carbon Dioxide (CO2) Laser. At this institution, the investigator has used CO2 for management of Burn Scars since 2012. While the existing literature and the investigator's anecdotal experience thus far has been positive overall, there is no conclusive evidence to support that CO2 does indeed improve the quality of mature burn scars

The primary objective of this study is to evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.

Eligibility criteria: Inclusion Criteria:

* Age 3 to 21
* Patients with mature burn scars that are at least two years old from burn injury and that have not previously undergone CO2 laser therapy for scar revision.
* Scars in all body areas with the exception of face, genitals or hands will be considered eligible for the study
* Entry into this study is open to pediatric patients of both genders.
* Entry into this study is open to pediatric patients of all ethnic backgrounds.
* Entry into this study is open to females of childbearing potential with a negative urine or serum pregnancy test

Exclusion Criteria:

* Patients with scars less than 2 years old
* Patients with contraindications to laser treatment (i.e.: active acne infections/ treatment with isotretinoin, active Zoster infection)
* Patients receiving other forms of scar revision therapy such as other laser types, steroid injections, or surgical excisions.

Primary outcomes:
measure: Change in scar assessment evaluation
timeFrame: Prior to initial treatment and no sooner than 3 months following last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Shriners Hospitals for Children
state: California
Study officials:
affiliation: UC Davis
name: Pirko Maguina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05034549: Noninvasive Ventilation for Chronic Heart Failure
Official title: Efficacy and Safety of Home Non-invasive Ventilation Based on Polysomnography in Chronic Stable Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stable Heart Failure
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 150
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: The effects of home noninvasive ventilation on renin-angiotensin system (RAS), kallikrein-kinin system (KKS) and cardiac remodeling in patients with chronic stable heart failure have not been reported. This project aims to clarify the efficacy and safety of home non-invasive ventilation in patients with chronic heart failure complicated with sleep-disordered breathing. First, patients with chronic stable heart failure were selected and monitored by polysomnography. Patients with sleep apnea hypopnea syndrome (SAHS, AHI≥15) were randomly divided into two groups: the treatment group was treated with non-invasive ventilator at home (≥5h/ night); The control group was only given routine treatment. After 6 months of follow-up, the effects of sleep disordered breathing and noninvasive ventilation on RAS, KKS, cardiac remodeling and function and cardiovascular adverse events in patients with chronic heart failure were evaluated. The results are helpful to further reveal the role of sleep disordered breathing in the occurrence and development of chronic heart failure, and provide a new diagnosis and treatment strategy for chronic heart failure.


Eligibility criteria: Inclusion Criteria:

* 1) The history of chronic stable heart failure exceeds 3 months; 2) 18\~75 years old; 3) NYHA cardiac function classified as grade II\~IV; 4) LVEF≤40%； 5) NT-proBNP≥450pg/ml； 6) All subjects or their guardians must sign the subject consent before entering the trial.

Exclusion Criteria:

* 1) Patients with the following diseases: valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; acute coronary syndrome; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor; 2) Patients with poor sound transmission windows are examined by transthoracic ultrasound.

Primary outcomes:
measure: Cardiac remodeling
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital Affiliated to Shandong First Medical University
Study officials:
References:
Clinical trial NCT00290849: ImproveR International (BI-001-IM)
Official title: European Registry of Consecutive Patients Undergoing PCI Evaluating the Use of the Thrombin-specific Anticoagulant Bivalirudin With Focus on Patient Selection, Convenience and Safety Aspects.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The objectives of this registry are to assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In particular, data will be collected to analyze experiences of bivalirudin use in respect to the following objectives;

* examine the aspects of safety and effectiveness of bivalirudin
* gain experience regarding the characteristics of patients in bivalirudin treatment
* evaluate the handling of bivalirudin and its practicality


Eligibility criteria: Inclusion Criteria:

\> 18 years, undergoing planned or urgent PCI with the intention to use bivalirudin as anticoagulant, written informed concent to entry of data information registry.

Exclusion Criteria:

None

Primary outcomes:
measure: To assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In particular, data will be collected to analyze experiences of bivalirudin use in respect to the following;
measure: •examine the aspects of safety and effectiveness of bivalirudin
measure: •gain experience regarding the characteristics of patients in bivalirudin treatment
measure: •evaluate the handling of bivalirudin and its practicality.
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Nycomed
Study officials:
affiliation: Headquaters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References:
Clinical trial NCT03092349: SonR Based Stimulation-VECtor OPTimisation in CRT Patients
Official title: Effect of SonR Based Stimulation-VECtor OPTimisation in Patients With Chronically Implanted Cardiac Resynchronization Devices
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Resynchronization Therapy
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 10
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: Patients with a CRT-D system providing the possibility of SonR-based optimisation of AV-D and VV-D

Brief summary: The primary aim of the present study is to investigate whether the optimisation of LVSV in addition to the optimisation of AV-D and VV-D when using the device-based sensor technology mentioned above results in an improved clinical outcome of CRT. Moreover, noninvasive measurements are intended to evaluate hemodynamic differences between the different stimulation configurations using the Finapres® method.


Eligibility criteria: Inclusion Criteria:

* Indication for CRT-D implantation according to guidelines at the time of implantation
* Implanted CRT-D system with SonR sensor technology
* Sinus rhythm
* NYHA class II-IV
* Age ≥ 18 years
* Written informed consent to participate in the study

Exclusion Criteria:

* Patients having received a CRT system without SonR sensor technology
* Patients with an insufficient SonR signal
* Confirmed pregnancy
* Age \< 18 years
* Life expectancy \< 1 year
* Atrial fibrillation / atrial flutter at the time of enrollment
* Unability to give informed consent
* Participation in another clinical study with active therapeutic arm
* Regular follow-up at the study site from enrolment to 12 months follow up not guaranteed

Primary outcomes:
measure: NT-proBNP decrease (-15%)
timeFrame: 12 months
measure: VO2max (+ ≥0.7 ml/min/kg)
timeFrame: 12 months
measure: NYHA class (improvement by ≥ 1 class)
timeFrame: 12 months
measure: QOL (MLHF), score reduction (-15)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
Study officials:
affiliation: Clinic for Cardiology, Heart and Diabetes Center North Rhine-Westphalia
name: Klaus-Jürgen Gutleben, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05632549: The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma
Official title: The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Moderate Persistent Asthma
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 66
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children with Moderate Persistent Asthma


Eligibility criteria: Inclusion Criteria:

* Children with moderate persistent asthma
* Age range of 8-\< 18 years old
* Both sex

Exclusion Criteria:

* Children with any pulmonary or chronic systemic diseases other than asthma (cystic fibrosis, bronchiectasis, tuberculosis, diabetes mellitus, and liver disease).
* Children with immunodeficiency.
* Children with thyroid disorder.
* Children with recent infection (especially pneumonia), surgery, anesthesia.
* Children having clinical evidence of any heart renal and hepatic diseases.
* Children having cystic fibrosis or congenital respiratory disease.
* Children having chronic diarrhea and mal-absorption.
* Children having clinical evidence of malnutrition.
* Children on medications that could interfere with L-carnitine level including antibiotics use. (particularly ampicillins) and anti- convulsing particularly valoproic acid.

Primary outcomes:
measure: Pulmonary function test (PFT)
timeFrame: 3 months
measure: Childhood asthma control test (C-ACT)
timeFrame: 3 months
Secondary outcomes:
measure: serum levels of TGF-β1
timeFrame: at baseline and 3 months after intervention
measure: serum levels of TNF-α
timeFrame: at baseline and 3 months after intervention
measure: serum levels of 8-OHDG
timeFrame: at baseline and 3 months after intervention
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Gharbia
Study officials:
References:
Clinical trial NCT01416649: Impact of Exenatide on Sleep Duration
Official title: Impact of Exenatide on Sleep Duration and Quality in Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-08-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience Sample

Brief summary: This study investigates the effect of exenatide, a FDA approved medication for the treatment of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be studied before and during treatment with Exenatide.

Enrolled individuals will be asked to come to the University of Chicago for 3-4 outpatient visits over the course of 3-4 months.


Eligibility criteria: Inclusion Criteria:

Patients taking diabetes medications other then insulin will be included, but changes to their medications may be made as deemed necessary by their physician. Patients on stable medications for chronic and co-morbid conditions (high blood pressure, high cholesterol, etc) will be eligible

Exclusion Criteria:

Patients with moderate or severe kidney disease and history of pancreatitis or patients on insulin will be excluded, as Exenatide use is contraindicated or risky in these conditions.

Patients with unstable cardiac, neurological or psychiatric disease and women who are pregnant or trying to get pregnant will be excluded. Patients who have severe COPD, severe neuropathy or chronic pain, which could impair sleep, will be excluded. Shift workers will be also excluded.

Primary outcomes:
measure: Sleep duration and sleep efficiency
timeFrame: at the end of 3 months of treatment with the medication
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Silvana Pannain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00075049: Safety and Efficacy Study of RTS,S AS02A/AS01B Vaccine to Prevent Malaria
Official title: Dbl-Blind, Rand Phase 1/2a Human Challenge Study, to Eval Safety, Reactogenicity, Immunogenicity and Preliminary Efficacy After Sporozoite Challenge/Rechallenge of Vaccines Containing RTS,S
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malaria
Keywords: malaria
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: GlaxoSmithKline
name: Walter Reed Army Institute of Research (WRAIR)
First posted: 2004-01-01
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a double blinded study where 2 test vaccines will be evaluated to see if they protect persons who have never had malaria against malaria infection when bitten by mosquitoes.


Eligibility criteria: Inclusion Criteria:

* Be in good general health
* Be able to participate for 4-15 months

Exclusion Criteria:

* Pregnant or planning pregnancy
* History of malaria or exposure to malaria in past 12 months
* Received an investigational malaria vaccine
* Past history of allergic reaction to previous immunization
* Positive blood tests for HIV and specific types of hepatitis

Primary outcomes:
measure: To assess the safety and reactogenicity of the candidate vaccine
Secondary outcomes:
measure: To assess the humoral immune response to the candidate vaccine
measure: To assess the efficacy of the candidate vaccine
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Walter Reed Army Institute of Research
state: Maryland
Study officials:
affiliation: Walter Reed Army Institute of Research (WRAIR)
name: Kent Kester, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stewart VA, McGrath SM, Walsh DS, Davis S, Hess AS, Ware LA, Kester KE, Cummings JF, Burge JR, Voss G, Delchambre M, Garcon N, Tang DB, Cohen JD, Heppner DG Jr. Pre-clinical evaluation of new adjuvant formulations to improve the immunogenicity of the malaria vaccine RTS,S/AS02A. Vaccine. 2006 Oct 30;24(42-43):6483-92. doi: 10.1016/j.vaccine.2006.06.033. Epub 2006 Jul 3.
citation: Kurtovic L, Atre T, Feng G, Wines BD, Chan JA, Boyle MJ, Drew DR, Hogarth PM, Fowkes FJI, Bergmann-Leitner ES, Beeson JG. Multifunctional Antibodies Are Induced by the RTS,S Malaria Vaccine and Associated With Protection in a Phase 1/2a Trial. J Infect Dis. 2021 Oct 13;224(7):1128-1138. doi: 10.1093/infdis/jiaa144.
citation: Kester KE, Cummings JF, Ofori-Anyinam O, Ockenhouse CF, Krzych U, Moris P, Schwenk R, Nielsen RA, Debebe Z, Pinelis E, Juompan L, Williams J, Dowler M, Stewart VA, Wirtz RA, Dubois MC, Lievens M, Cohen J, Ballou WR, Heppner DG Jr; RTS,S Vaccine Evaluation Group. Randomized, double-blind, phase 2a trial of falciparum malaria vaccines RTS,S/AS01B and RTS,S/AS02A in malaria-naive adults: safety, efficacy, and immunologic associates of protection. J Infect Dis. 2009 Aug 1;200(3):337-46. doi: 10.1086/600120.
Clinical trial NCT03504449: Surgery Without Neoadjuvant Chemoradiotherapy Compared With Neoadjuvant Chemoradiotherapy for Rectal Cancer With Negative Circumferential Resection Margin Based on MRI Assessment, a Perspective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Circumferential Resection Margin
Intraoperative Perforation of Rectum
Local Recurrence of Malignant Tumor of Rectum
Disease-free Survival
Overal Survival
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 350
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: For now, neoadjuvant chemoradiotherapy is routinely performed for T3N1-2M0 rectal cancer. However, there are lots of complications following neoadjuvant chemoradiotherapy, such as Wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction, testicular or ovary failure. Patients undergoing resection for rectal cancer had low rates of local recurrence and long disease-free survival regardless of whether an APR, CAA or low AR was performed. The main purpose of preoperative radiotherapy is to lower the local recurrence. For the T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, we suppose might not necessary to receive neoadjuvant chemoradiotherapy, for operation can achieve the negative circumferential resection margin.


Eligibility criteria: Inclusion Criteria:

1. Tumor within 12 cm of the anal verge
2. T3N1-2 as determined by preoperative MRI examination
3. negative circumferential resection margin determined by preoperative MRI examination
4. Absence of distant metastases
5. Absence of intestinal obstruction

Exclusion Criteria:

1. With distant metastases
2. With intestinal obstruction
3. Pregnancy or lactation
4. With operation contraindication
5. With mental disorder

Primary outcomes:
measure: circumferential resection margin
timeFrame: one week after operation
measure: introperative perforation
timeFrame: During the operation
Secondary outcomes:
measure: local recurrece
timeFrame: 3 years after operation
measure: overal survival
timeFrame: 3 years after operation
measure: disease-free survival
timeFrame: 3 years after operation
measure: complications
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
Study officials:
References: