louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04053296: Long-term Outcomes of Pregnant Women With PAH
Official title: Morbidity and Outcomes of Pregnant Women With Pulmonary Arterial Hypertension During Different Pregnancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The first pregnancy group was composed of patients diagnosed with PAH in their first pregnancy. Patients in the second pregnancy group were diagnosed with PAH during their second pregnancy but normal in their first pregnancy.

Brief summary: The investigators intend to explore the characteristics and outcomes of pregnant women with PAH during different pregnancies and to provide applicable evidence for clinical practice.

Detailed description: Pulmonary arterial hypertension (PAH) is a fatal disease with progressive vascular resistance that leads to the loss of right heart function. Avoiding pregnancy is essential for PAH women. In recent years, maternal mortality in pregnant women with PAH has decreased mostly due to emerging advanced therapies for PAH and the progress in high-risk pregnancy management. Nevertheless, the maternal death rate in parturients with PAH remains high; therefore, contraception is still recommended for women diagnosed with PAH. However, some women develop this condition during pregnancy. With the two-child policy, families in China are allowed to have a second child. As a result, the number of PAH diagnoses during pregnancy may increase with the general increase in the number of pregnant women. Additionally, some patients develop PAH only during their second pregnancy. In order to investigate the incidence and clinical characteristics of pregnant women diagnosed with PAH during different pregnancies, this observational study aimed to analyze perinatal and pregnancy clinical data, to compare the perinatal status and maternal and infant outcomes of the first and second pregnancies complicated with PAH, establishing a clinical basis for the prenatal consultation, diagnosis, and treatment of pregnant women with PAH.

Eligibility criteria: Inclusion Criteria:

PAH was screened by Doppler echocardiography first. Echocardiographic criteria for the diagnosis of PAH included tricuspid regurgitation velocity \>2.8 m/sec, with extra more than one additional echocardiographic sign

Exclusion Criteria:

Cases of PH diagnosed before pregnancy, secondary to chronic lung disease, and left heart disease, as well as right ventricular outflow tract obstruction and congenital pulmonary stenosis.

Primary outcomes:
measure: Death
timeFrame: 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
name: Jieyan Shen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06544096: Application Evaluation of Newborn Home Skin Care Management System Under the Service of "WeChat Platform+Health Care"
Official title: Evaluation of the Effectiveness of a Neonatal Home Skin Care Guidance Based on We-chat: A Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infants
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 692
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Through the establishment of the newborn home skin care management system under the service of "WeChat platform+health care", the investigators focus on the common skin problems of newborns at home, push health education materials through the system, teach parents the methods and details of home skin care, and evaluate the effect of the system on reducing the incidence of newborn home skin problems and the prognosis of home skin problems through cluster randomized controlled research.

Detailed description: In this study, the cluster randomization method is used, and eight centers are assigned to the experimental group or the control group according to the ratio of 1:1. Randomization plan is made by independent statistical team in statistical software: by creating random seed numbers and sorting them, the intervention plan distribution of each center is determined. The outcome evaluator and the statistical analysis team will not know the grouping situation of each center.

In this study, there are 4 centers in the experimental group and 4 centers in the control group. Sample size calculation is based on the main outcome index: the incidence of diaper dermatitis in newborns at home.

Eligibility criteria: Inclusion Criteria:

* Newborns born in normal delivery (gestational age ≧35w)
* Newborns' parents can cooperate, have certain learning, reading and understanding abilities, and have the ability to care for newborns
* Voluntary participation in this study.

Exclusion Criteria:

* Newborns requiring hospitalization.
* Newborns diagnosed with congenital skin diseases.
* The newborn mother has mental illness.
* The newborn mother has a serious illness and needs hospitalization.

Primary outcomes:
measure: Incidence of diaper dermatitis in newborns at home
timeFrame: Within two months after birth
Secondary outcomes:
measure: Incidence rate of neonatal home atopic dermatitis (AD)
timeFrame: Within two months after birth
measure: Rate of Hospital Visits for Skin Problems
timeFrame: Within two months after birth
measure: Parental Knowledge of Home Skincare
timeFrame: Within two months after birth
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Hu Xiaojing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03504696: Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced Melanoma
Official title: Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced (Unresectable or Metastatic) Melanoma: A Multicentric, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RIC-Mel patients with advanced (unresectable or metastatic) melanoma treated with nivolumab in the context of nivolumab ATU program (occurred from 12-Sep-2014 to 31-Aug-2015).

Brief summary: This study will be conducted with the aim of estimating the effectiveness, safety, patterns of use of nivolumab, and characteristics of patients with unresectable or metastatic melanoma, treated with nivolumab monotherapy in the ATU setting.


Eligibility criteria: Inclusion Criteria:

* Patients included in RIC-Mel Database:

  * Diagnosed with melanoma and cared for in the participating sites
  * Patients who have been given appropriate information about RIC-Mel Database aims and who have provided their written consent for data collection and processing before any data collection is carried out
* Patients included in French nivolumab ATU program

Exclusion Criteria:

• Patients included in RIC-Mel database having initiated nivolumab before 12-Sep-2014 or after 31-Aug-2015, or in the context of a clinical trial

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Overall survival (OS) at 1 year
timeFrame: at 1 year
measure: Distribution of demographic characteristics of patients with advanced melanoma treated with nivolumab monotherapy in the ATU program
timeFrame: at baseline
measure: Distribution of clinical characteristics in patients with advanced melanoma treated with nivolumab monotherapy
timeFrame: at baseline
measure: Overall survival (OS) at 2 years
timeFrame: at 2 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 1 year and 2 years
measure: Objective response rate (ORR)
timeFrame: 1 year and 2 years
measure: Progression-free survival (PFS) as assessed by RECIST 1.1
timeFrame: at 1 year
measure: Distribution of treatment patterns
timeFrame: up to 2 years
measure: Incidence of select Grade 3, 4, or 5 adverse events (AEs)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Nantes Cedex 1
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03141996: Use of Vibration to Improve Visual/Spatial Neglect in Patients Affected by Stroke
Official title: Use of Vibration to Improve Visual/Spatial Neglect in Patients Affected by Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Unilateral Spatial Neglect
Keywords: vibration
stroke
activities of daily living
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will measure if five minutes of vibration to the upper back neck muscles, prior to standard of care treatment, will improve symptoms of spatial neglect and/or activities of daily living function for patients who have had a stroke.

Detailed description: Spatial neglect is a common syndrome following stroke, most frequently of the right side of the brain. Such patients fail to be aware of objects or people to their left. This study is being done to learn if vibration treatment can improve visual/spatial neglect and activities of daily living in stroke patients better than current standard intervention.This treatment will be performed by occupational therapist practitioners prior to regular occupational therapy session using a vibration tool.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* demonstrated visual/spatial neglect, as demonstrated by NIH Stroke Scale (NIHSS) and deficits in assessing tactile extinction and visuospatial neglect done on admission.

Exclusion Criteria:

* severe pain or skin disease at the posterior neck
* severe atherosclerosis of carotid arteries by an ultrasonic evaluation

Primary outcomes:
measure: Behavioral Inattention test
timeFrame: Day 0
Secondary outcomes:
measure: Behavioral Inattention test
timeFrame: Day 30
measure: Behavioral Inattention test
timeFrame: Day 60
measure: Catherine Bergego Scale (CBS)
timeFrame: Day 0
measure: Catherine Bergego Scale (CBS)
timeFrame: Day 30
measure: Catherine Bergego Scale (CBS)
timeFrame: Day 90
measure: Activity Measure for Post-Acute Care (AM-PAC)
timeFrame: Day 0
measure: Activity Measure for Post-Acute Care (AM-PAC)
timeFrame: Day 30
measure: Activity Measure for Post-Acute Care (AM-PAC)
timeFrame: Day 60
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Florentina Mueller-Planitz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
Clinical trial NCT00320996: SGO Society of Gynecologic Oncologists Data Outcomes Project
Official title: SGO Society of Gynecologic Oncologists Data Outcomes Project
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pelvic Tumor
Keywords: Pelvic mass
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with a pelvic mass who will have surgery

Brief summary: SGO Society of Gynecologic Oncologists Data Outcomes Project.

Detailed description: Examines data over period of time

Eligibility criteria: Inclusion Criteria:

1. Must have a pelvic mass with surgery taking place.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Harriet Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06116396: Liquid Biospy for Urinary Cancers
Official title: Use of Urinary Tumor Cells and Circulating Tumor Cells (CTCs) in the Prognosis and Therapy of Patients With Bladder (BCa) and Upper Urinary Tract (UTUC) Cancer"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urothelial Carcinoma
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults men and women.

Brief summary: The project aims to characterize the prognostic role of CTCs in Bladder cancer patients, with the specific aims to better stratify patients with non-muscle invasive bladder cancer at the first transurethral resection of tumor and to identify urothelial biomarker expressed by CTCs.

Detailed description: Bladder cancer (BCa) is the 9th most common cancer worldwide, with an estimated prevalence of around 2.7 million cases and an incidence around 350.000 new cases/year. The proper management of BCa remains an unmet clinical need, because one of the main problems in BCa treatment is the inability to efficaciously prevent high-grade non-muscle invasive bladder cancer (NMIBC) relapse and progression, which occur in 80% and 45% of patients respectively. Indeed, as a consequence of the lack of efficient established prognostic, diagnostic and predictive biomarker of high-risk NMIBC, Bca patients undergo multiple treatments and cystoscopic assessments along their life, with consequent poor quality of life and high healthcare costs.

Circulating Tumor Cells (CTCs) in blood represent an invaluable source of tumor material that can be easily collected yhrough a simple blood draw and may represent the clonal component of the primary tumor that left the primary site.

For this reason, the aim of this study is to characterize the prognostic role of CTCs in Bladder cancer patients, with the specific aims to better stratify patients with non-muscle invasive bladder cancer at the first transurethral resection of tumor and to identify urothelial biomarker expressed by CTCs.

Eligibility criteria: Inclusion Criteria:

Diagnosis of urothelial neoplasia, naive for therapy

Exclusion Criteria:

Absence of previous neolpastic disease or genetic diseases

Primary outcomes:
measure: Prognostic role of the liquid biopsy
timeFrame: 2020-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Urology Department
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Massimo Alfano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05775796: Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)
Official title: A Single-arm, Multicenter, and Phase II Clinical Study to Evaluate the Efficacy and Safety of Serplulimab Combined With Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable Stage II-IIIA NSCLC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Stage II-IIIA
Immunotherapy
Neoadjuvant Therapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 30
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: This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1013. The purpose of this neoadjuvant and adjuvant study is to evaluate the efficacy and safety of Serplulimab and chemotherapy in treating resectable Non-Small Cell Lung Cancer(NSCLC).


Eligibility criteria: Inclusion Criteria:

* stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue.
* Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
* Eligible male and female subjects aged 18-75 years.
* Lung function capacity capable of tolerating the proposed lung surgery.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Available tissue of primary lung tumor.

Exclusion Criteria:

* Presence of locally advanced, inoperable or metastatic disease.
* Subjects with EGFR mutation or ALK、ROS1 gene rearrangement.
* Participants with active, known or suspected autoimmune disease.
* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Major Pathologic Response (MPR) Rate
timeFrame: From start of treatment to 6 months
Secondary outcomes:
measure: Pathologic Complete Response (pCR) Rate
timeFrame: From start of treatment to 6 months
measure: R0 resection rate
timeFrame: From start of treatment to 6 months
measure: Objective remission rate(ORR)
timeFrame: approximately up to 12 months
measure: Event-Free Survival (EFS)
timeFrame: From enrollment to disease progression, reoccurrence, or death due to any cause.(Up to a median of 22 months)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT00415896: Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance
Official title: Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Respiratory Failure
Keywords: weaning
work of breathing
spontaneous breathing trial
rapid shallow breathing
Lead sponsor: Krankenhaus Kloster Grafschaft
Sponsor class: OTHER
First posted: 2006-12-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study investigates how different degrees of muscular unloading during mechanical ventilation impact endurance of succeeding spontaneous breathing trials

Detailed description: Liberation from mechanical ventilation in difficult to wean patients is best accomplished by intermittent spontaneous breathing trials (1). Optimal respiratory muscle rest in-between breathing trials however has never been investigated.

Using a crossover design, patients are to be ventilated with complete and partial respiratory muscle unloading for a period of ten hours respectively. Respiratory muscle activity is being monitored by oesophageal balloon technique using a commercially available System (Avea, Viasys, Conshohocken, PA, USA). Time of spontaneous breathing, respiratory- and ABG parameters are being determined to characterize the course of each spontaneous breathing trial.

References

1. Esteban, A., F. Frutos, M. J. Tobin, I. Alia, J. F. Solsona, I. Valverdu, R. Fernandez, M. A. de la Cal, S. Benito, R. Tomas, and et al. 1995. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med 332(6):345-50.

Eligibility criteria: Inclusion Criteria:

* hypercapnic respiratory failure

Exclusion Criteria:

* upper Gi pathology
* renal failure (creatinin \> 2 mg/dl)
* Sepsis or infection
* age \< 18 years

Primary outcomes:
measure: Endurance time
Secondary outcomes:
measure: PCO2, respiratory parameters
Other outcomes:
Locations:
city: Schmallenberg
country: Germany
facility: Kloster Grafschaft
state: Annostr. 1
Study officials:
affiliation: FKKG
name: Dominic Dellweg, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: FKKG
name: Dieter Koehler, M.D., Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT03599596: Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine
Official title: Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine in University College Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Malaria
Lead sponsor: University College Hospital, Ibadan
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 136
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized controlled prospective comparative study

Detailed description: This study is intended to be a randomized controlled comparative study conducted to compare the effect of monthly versus two doses of ante-natal intermittent preventive treatment with sulphadoxine-pyrimethamine

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Gestational age between 16 and 28weeks.
* No history of use of sulphadoxine-pyrimethamine prior to recruitment
* Not on any medication for prophylaxis

Exclusion Criteria:

* Anaemia
* HIV positive women
* Pre-existing medical conditions e.g diabetes mellitus, haemoglobinopathy, hypertension, kidney disease, heart disease, any endocrine disorder like hypo/hyperthyroidism, Cushing' disease, connective tissue disorders like systemic lupus erythematosus, antiphospholipid syndrome or any otherautoimmune disease with poor feto-maternal outcomes in pregnancy.
* History of Glucose -6-Phosphate Dehydrogenase (G6PD) deficiency in patient
* Allergy to sulphonamides or pyrimethamine.
* Non consenting patients
* Multiple gestations

Primary outcomes:
measure: Level of malaria parasitemia among pregnant women with monthly doses of sulphadoxine-pyrimethamine as compared to pregnant women with 2 doses of Intermittent Preventive Treatment of Malaria during Pregnancy with Sulphadoxine-Pyrimethamine (IPTp-SP).
timeFrame: 4 Months
Secondary outcomes:
measure: Prevalence of drug related adverse events associated with multiple doses of sulphadoxine pyrimethamine.
timeFrame: 4 Months
Other outcomes:
Locations:
Study officials:
References:
citation: Agomo CO, Oyibo WA, Odukoya-Maije F. Parasitologic Assessment of Two-Dose and Monthly Intermittent Preventive Treatment of Malaria during Pregnancy with Sulphadoxine-Pyrimethamine (IPTP-SP) in Lagos, Nigeria. Malar Res Treat. 2011;2011:932895. doi: 10.4061/2011/932895. Epub 2011 Oct 26.