louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01234571: Impact of Hemo-dialysis Therapy on Blood Levels of Treprostenil in End Stage Renal Disease Patients With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Hypertension
End-Stage Renal Disease
Hemo-dialysis Therapy
Keywords: Pulmonary hypertension
Remodulin (Treprostenil sodium)
End-stage renal disease
Hemo-dialysis
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients with PAH who receive chronic (more than 3 months) Treprostenil treatment administered intravenously as a single agent therapy who maintain chronic hemo-dialysis therapy. Patients must be in stable condition for at least one month. Patients other than class I PAH will be not included in this study.

Brief summary: Remodulin (Treprostenil sodium) is synthetic prostacyclin analog available as a solution for administration in the intravenous route. It is approved for treatment of class I - pulmonary hypertension functional capacity stage III-IV. A key factor for the success of pulmonary hypertension therapy is maintaining near constant blood level of a given medications along the day. A sudden decrease in the blood levels might lead to rebound phenomenon; abrupt increase in the pulmonary artery pressure which might lead to acute right ventricular failure and even to sudden death. As some PHT patients suffer are on hemo-dialysis therapy due to end-stage renal disease there is a need to document the variation of the blood level along the dialysis cycle.

Detailed description: After giving informed consent 10 ml of blood will be drawn from the study population at the following occasions.

* Baseline measurement immediately before starting HD therapy.
* During the hemo-dialysis therapy - every one hour.
* After the end of the hemo-dialysis therapy - every one hour (a total of four measurements) to record recovery of Treprostenil blood levels.

Eligibility criteria: Inclusion Criteria:patients with PAH who receive chronic (more than 3 months) Treprostenil treatment administered intravenously as a single agent therapy who maintain chronic hemo-dialysis therapy. Patients must be in stable condition for at least one month. Patients other than class I PAH will be not included in this study.

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03889171: Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests
Official title: Predisposition to Breast Cancer BRCA1 / BRCA2 and to HNPCC Colon : Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Colorectal Cancer
Breast Cancer
Ovarian Cancer
Keywords: genetic testing
genes BRCA1
genes BRCA2
mutation
family
disclosure
psychology
DNA mismatch repair
genetic predisposition to disease
cancer
oncology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female and male participants are being studied

Brief summary: The purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )

Detailed description: The risk associated with a genetic predisposition is among the various forms of risk, the strongest identifiable risk . It enables to offer people at risk an appropriate medical care (screening, prevention ) the clinical benefit is validated today. The person with whom a predisposing mutation has been identified must communicated its related information on the risk of cancer and the ability to perform genetic analysis. It appears that this dissemination of information is not always optimal, as shown in figures from the National Cancer Institute joined the project; the purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )

Eligibility criteria: Inclusion Criteria:

* Patient having a deleterious genetic mutation on genes BRCA1 and/or BRCA2 and or on genes MMR
* The patient being of the family (who carried out a full analysis of BRCA1/BRCA2 and/or those MMR )

Exclusion Criteria:

* Patient not carrying a deleterious genetic mutation on the BRCA1/2 genes and/or those of the MMR system,
* Patient under guardianship, curator or unable to give his non-opposition,
* Adult patients protected by law.

Primary outcomes:
measure: intrafamilial disclosure rate
timeFrame: On average 1 year
measure: relatives' genetic targeted testing uptake rate
timeFrame: On average 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02097771: Gastric Insufflation and Laryngeal Mask Airway
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Insufflation
Keywords: laryngeal mask airway ventilation
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2014-03-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks airways: LMA SupremeTM vs Ambu AuraOnceTM


Eligibility criteria: Inclusion Criteria:

* ASA 1 or 2
* Age \> 18 yrs
* Use of laryngeal mask airway required

Exclusion Criteria:

* risk of pulmonary aspiration of gastric contents
* Contraindication for the use of laryngeal mask airway
* Tracheal intubation required
* Patient's refusal

Primary outcomes:
measure: incidence of gastric insufflation
timeFrame: during pulmonary ventilation through the laryngeal mask airway
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT01794871: The Histological Analysis in Renal Transplantation Patients With Deterioration of Graft Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Allograft Dysfunction
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Maintenance living donor renal transplant recipients

Brief summary: Identify the cause of chronic allograft dysfunction using a combination of comprehensive clinical and histologic information in Chinese renal transplant recipients, then to identify the position of CNI nephrotoxicity in CAD.Chronic allograft dysfunction reflects the dual impact of both immunologic and nonimmunologic (primarily calcineurin inhibitor \[CNI\]nephrotoxicity) injury. In previous, CNI nephrotoxicity is overstated and considered one of the major causes of CAD, however, recently there has been found most death-censored graft losses to be the result of alloimmune or autoimmune injury, with only a minority of cases attributable to CNI toxicity. Unfortunately, Situation of objective CNI toxicity in CAD in China is not well analyzed. To improve perception of Neo safety with more local evidence, we want to do a retrospective study to identify the cause of chronic allograft dysfunction using a combination of comprehensive clinical and histologic information in Chinese renal transplantation recipients.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Kidney transplant recipients, only including recipients of living-donor grafts
* Underwent an allograft biopsy between January 2005 and December 2011 because of developing deterioration of graft function\*.

  * Deterioration of function was defined as (1) an unexplained and persistent greater than or equal to 25% increase of CR over baseline (in the absence of potential confounding factors) or (2) new onset proteinuria (defined as albumin/CR ratio ≥0.2 or a protein/CR ratio \>0.5).

Exclusion Criteria:

* Multiple organ transplants, prior transplant with any other organ or tissue
* Patients who did not have the information regarding the pathological diagnosis
* Patients who did not have the histological sections of the allograft biopsy

Primary outcomes:
measure: the graft biopsy of maintenance living donor renal transplant recipients who underwent deterioration of graft function
timeFrame: up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT04068571: Enhancing Universal Health Coverage and Maternal, Newborn and Child Health in Kenya Through Digital Innovations
Official title: Innovative Partnership for Universal Health Coverage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Universal Health Coverage
Lead sponsor: African Population and Health Research Center
Sponsor class: OTHER
Collaborators: name: Amsterdam Institute for Global Health and Development
name: PharmAccess
First posted: 2019-08-28
Enrollment: 300
Sex: MALE
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims at providing insights into Universal Health Coverage and evaluates the impact of I-PUSH program on maternal healthcare utilization, financial protection and women's empowerment, as well as to evaluate the impact of the LEAP training tool on community health volunteers and women's health literacy including their knowledge, behavior and uptake of respective services.

Detailed description: The study will use a three-pronged approach: year-long weekly Financial and Health Diaries, Baseline and Endline surveys, and qualitative interviews. The Diaries and the Surveys will be carried out in two Counties, Kakamega and Kisumu (Kenya). The qualitative interviews will be carried out in the two counties and in Nairobi as an additional county. The study will use a cluster randomized control trial design in Kakamega to evaluate the impact of I-PUSH program. In Kisumu, selected households will be followed-up to capture the health-seeking behavior, health insurance, and health expenditure pattern of households over time. The study will be initially for 17 months and will continue for three years subject to additional funding.

Eligibility criteria: Inclusion Criteria:

* Targets for the intervention

Exclusion Criteria:

* Non-targets for the intervention

Primary outcomes:
measure: Health Care Utilization
timeFrame: 17 months
measure: Maternal, Newborn and Child Health outcomes through out the continuum of care
timeFrame: 17 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Abajobir A, de Groot R, Wainaina C, Njeri A, Maina D, Njoki S, Mbaya N, Donfouet HPP, Pradhan M, Janssens W, Sidze EM. The impact of i-PUSH on maternal and child health care utilization, health outcomes, and financial protection: study protocol for a cluster randomized controlled trial based on financial and health diaries data. Trials. 2021 Sep 15;22(1):629. doi: 10.1186/s13063-021-05598-7.
Clinical trial NCT00819871: Nuclear Factor Kappa-B (NFKB1) Polymorphism and Organ Injury After Cardiac Surgery
Official title: Association of NFKB1 -94 Polymorphism With Lung and/or Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Single Nucleotide Polymorphism
Acute Lung Injury
Kidney Injury
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2009-01-09
Enrollment: 105
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: Chinese Han patients undergoing elective cardiac surgery with CPB

Brief summary: NFKB1 -94ins/del polymorphism has been reported to be associated with reduced promoter activity of NFKB1 and several clinical diseases, but the clinical results cannot always be replicated. Besides, mutate allele is associated with alleviated inflammation in ulcerative colitis and some tumors, but aggravated inflammation in ARDS. The clinical value of this polymorphism remains controversial. This study was performed to investigate the association of NFKB1 -94ins/delATTG polymorphism with lung and/or kidney injury after cardiac surgery with CPB.


Eligibility criteria: Inclusion Criteria:

* Chinese Han unrelated population
* undergoing elective cardiac surgery with CPB

Exclusion Criteria:

* malignant tumor
* autoimmune disease, immunodeficiency or immunosuppressive therapy
* chronic renal disease (glomerular filtration rate \< 60ml/(min•1.73m2)) or liver dysfunction (Child Pugh classification\>A)
* COPD, tuberculosis or other chronic pulmonary diseases
* anemia with hemoglobin lower than 90mmHg
* bleeding disorders
* postoperative pericardial tamponade requiring re-operation
* postoperative low cardiac output syndrome or acute pulmonary edema after left cardiac failure.

Primary outcomes:
measure: lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass
timeFrame: 24h after cardiac surgery
Secondary outcomes:
measure: circulating level of CRP, TNF-alpha, IL-10; APACHE Ⅱ score; duration of ICU stay and hospitalization; death in 28 days
timeFrame: one month after cardiac surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
References:
citation: Wang JF, Bian JJ, Wan XJ, Zhu KM, Sun ZZ, Lu AD. NFKB1-94ins/del polymorphism is not associated with lung injury after cardiopulmonary bypass. Anaesthesia. 2010 Feb;65(2):158-62. doi: 10.1111/j.1365-2044.2009.06186.x. Epub 2009 Nov 25.
Clinical trial NCT03482271: Connected Yorkshire: A Data-linkage Study of Pre-hospital, Emergency Department and Out of Hours Service Data
Official title: Analysing Emergency and Urgent Care System Demand in Yorkshire and Humber: A Data-linkage Study of Pre-hospital, Emergency Department and Out of Hours Service Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergency and Urgent Care Pathways
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: Northern Health Science Alliance (NHSA)
First posted: 2018-03-29
Enrollment: 7500000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any person who has accessed an urgent and emergency care service in Yorkshire and the Humber region between 2011 and 2017

Brief summary: There is increased demand on emergency departments (ED) across the UK. The services are becoming stretched and as a result waiting times are increasing and patient care is suffering.

By linking together patient data from different hospitals and services across Yorkshire, researchers are able to build a more complete picture of how emergency and urgent care (UEC) services in the region function.

This picture will help researchers understand the flow of patients through EUC services, to understand what the most common health issues are and to better plan community services in the future. The anonymous data can help scientists understand EUC services across an entire region and suggest improvements in a much more synchronised way.

Health service managers will also be able to understand how one ED in Yorkshire compares to another. By re-using existing data researchers will also allow hospitals to learn lessons from each other so that each local service can improve and deliver better care for its patients.

In the future, this information will help researchers to plan ahead and forecast disease outbreaks. The data used will, over time, tell a story that will help deliver better and more targeted care.

The aim of the research project is to build a unique dataset based on expertise already being developed across the Yorkshire and Humber region. We will collect routine NHS data from a number of providers of EUC and link the data to provide a coherent picture of EUC demand. This rich data source will allow the EUC services to be viewed as a whole system, enabling demand on the system by patients to be analysed as well as the flow of patients through the system.


Eligibility criteria: Inclusion Criteria:

* access urgent and emergency care services in Yorkshire and the Humber region between 2011 and 2017

Exclusion Criteria:

* None

Primary outcomes:
measure: NHS111
timeFrame: 2011-2017
Secondary outcomes:
measure: YAS
timeFrame: 2011-2017
measure: Direct ED
timeFrame: 2011-2017
Other outcomes:
measure: Mapping of UEC service use
timeFrame: 2011-2017
Locations:
Study officials:
References:
Clinical trial NCT05429671: Antibiotic Loaded Cement After TKA
Official title: Drug Elution Profile and Minimum Inhibitory Concentration of Antibiotic-loaded Cement After Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Total Knee Arthoplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will provide us with clear information about the postoperative concentration of antibiotic reached in synovial fluid, thereby helping surgeons to determine if concentration could potentially prevent the growth and regrowth of common infecting microorganisms (based on their MIC and MBEC). There is a need to define the actual benefit of antibiotic-loaded bone cement, because the addition of antibiotic can reduce its mechanical strength. Moreover, if sub-therapeutic antibiotic levels are achieved, this could facilitate the emergence of resistant bacterial strains. Amidst the transition towards value-based care, our research will enable surgeons to decide whether antibiotic-loaded cement is truly cost-effective in the prevention of PJI.


Eligibility criteria: Inclusion Criteria:

* All participants undergoing cemented primary total knee arthroplasty (TKA) who are 18 years or older.

Exclusion Criteria:

* Withdrawal of informed consent,
* allergy to any of the study medications or to bone cement,
* use of antibiotics within 4 weeks before collecting the samples (not including perioperative antimicrobial prophylaxis),
* high risk of infection,
* history of peri-articular injections for multimodal pain management.

Primary outcomes:
measure: Antibiotic concentration
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05576571: The Utility of Cell-free Methylation Markers in Blood for Hepatocellular Carcinoma
Official title: The Utility of Cell-free Methylation Markers in Blood for the Prognosis Prediction of Locoregional Treatment for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Serum Tumor Markers
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with liver cancer by AASLD clinical criteria or pathological sections are planned to receive treatment at National Taiwan University Hospital Liver local treatment such as radiofrequency ablation or transvascular embolization.

Brief summary: Patients with liver cancer expected to undergo radiofrequency ablation or transvascular embolization. Relevant tumor markers (AFP and methylation analysis) were performed. The two data are then counted and compared.

Detailed description: The subjects of this study were patients who were diagnosed with liver cancer by physicians based on AASLD clinical criteria or pathological biopsy.

Patients are those who received radiofrequency ablation or transvascular embolization in National Taiwan University Hospital. Which excludes weakness and inability to cooperate Patients with blood test, under the condition of fully informed consent, complete blood test related tumor indicators (AFP and methylation analysis). The two data are then counted Compare.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with liver cancer by AASLD clinical criteria or pathological sections are planned to receive treatment at National Taiwan University Hospital Liver local treatment such as radiofrequency ablation or transvascular embolization.
2. Be over 20 years old.
3. Under the condition of informed consent, willing to sign the consent form of the subjects.

Exclusion Criteria:

1. Patients who are weak and unable to cooperate with blood test.
2. Kidney dysfunction, serum creatinine greater than 1.5mg/dl, it is judged that computer tomography or MRI cannot be performed Vibrate the injector.

Primary outcomes:
measure: Evaluate efficacy (methylation profiling results)
timeFrame: 3 month after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: study principal investigator
name: Kai-Wen Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: