louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00431418: The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease
Official title: The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Diseases
Lead sponsor: Mercy Hospital for Women, Australia
Sponsor class: OTHER
First posted: 2007-02-05
Enrollment: 20
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to investigate in a randomised double-blind trial whether treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at 28 weeks of gestation or less.


Eligibility criteria: Inclusion Criteria:

* Newborn babies born \<28 weeks of gestation who still need ventilatory support via endotracheal tube or have been re-ventilated at day 7 of life.

Exclusion Criteria:

* Congenital heart defects
* Suspected inborn error of metabolism
* Inhaled Nitric Oxide treatment during assessment

Primary outcomes:
measure: Length of ventilation
timeFrame: 12 months after completion of study
Secondary outcomes:
measure: Bronchopulmonary Dysplasia (BPD)
timeFrame: 12 months after completion of study
Other outcomes:
Locations:
city: Heidelburg
country: Australia
facility: Mercy Hospital for Women
state: Victoria
Study officials:
affiliation: Mercy Hospital for Women
name: Kai König, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Hospital for Women
name: Charles P Barfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Hospital for Women
name: Chad C Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06211218: Artificial Intelligence for Screening of Multiple Corneal Diseases
Official title: Application of Deep Learning for Screening Multiple Corneal Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deep Learning
Corneal Disease
Screening
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is derived from an anonymous database that contains health examination results of the general population.

Brief summary: This study developed a deep learning algorithm based on anterior segment images and prospectively validated its ability to identify corneal diseases.The effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.


Eligibility criteria: Inclusion Criteria:

1. The quality of slit-lamp images should clinical acceptable.
2. More than 90% of the slit-lamp image area including three main regions (sclera, pupil, and lens) are easy to read and discriminate.

Exclusion Criteria:

1）Insufficient information for diagnosis.

Primary outcomes:
measure: Area under curve
timeFrame: 1 week
measure: Sensitivity and specificity
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tiajin Eye Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Eye Hospital
name: Yan Wang, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT01279018: Persistent Pain After Breast Cancer Treatment With Docetaxel
Official title: Persistent Pain After Breast Cancer Treatment With Docetaxel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Pain, Postoperative
Neuralgia
Lymphedema
Keywords: Persistent postsurgical pain
breast cancer
postmastectomy pain syndrome
neuropathic pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 2490
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for breast cancer in Denmark 2007 and 2008

Brief summary: Breast cancer treatment is for many patients followed by sequelae, such as persistent pain, sensory disturbances, lymphedema and reduced physical function. These undesired consequences of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients. Development of persistent pain after breast cancer treatment, involves a complex pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors for the development of persistent pain after breast cancer treatment have been identified; young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is a well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this nationwide study is to retrospectively examine a cohort of breast cancer patients treated with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of persistent pain and other sequelae.


Eligibility criteria: Inclusion Criteria:

* Treated for primary breast cancer in Denmark 2007-2008
* Age between 18-80 years
* No recurrent cancer
* Female

Exclusion Criteria:

* Previous breast surgery same side (including plastic and reconstructive surgery)
* Bilateral breast surgery
* Recurrent cancer or metastatic cancer

Primary outcomes:
measure: Docetaxel as a risk factor for development of persistent pain
timeFrame: Between 2-3 years post surgery
Secondary outcomes:
measure: Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations
timeFrame: Between 2-3 years post surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01290718: A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.
Official title: Study of Trastuzumab Combined With Capecitabine on HER2-positive Metastatic Breast Cancer Patients Pretreated With Trastuzumab and Taxanes or HER2- Positive Breast Cancer Patients Relapsed From (Neo)Adjuvant Therapy of Trastuzumab and Taxanes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm. open-label study will assess the efficacy and safety of Herceptin (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14 of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Female patients, 18-65 years of age
* Histologically confirmed HER2-positive breast cancer with measurable lesions (according to RECIST criteria)
* Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with Herceptin and taxanes
* ECOG performance status 0-2

Exclusion Criteria:

* CNS metastases which are not well controlled
* Simultaneous treatment with sorivudine
* History of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix
* Pregnant or lactating women

Primary outcomes:
measure: Percentage of Participants With Overall Response
timeFrame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Secondary outcomes:
measure: Time to Disease Progression
timeFrame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
measure: Overall Survival
timeFrame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
measure: Progression-Free Survival
timeFrame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Other outcomes:
Locations:
city: Chai Yi
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01336218: Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.
Official title: An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Healthy Volunteers
Keywords: Phase 1
healthy volunteers
Rheumatoid arthritis
RA
Fostamatinib
Rifampicin
drug-drug interaction
Pharmacokinetics
Amount of Rifampicin in blood
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-04-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Males or females aged 18 to 55 years (inclusive)
* Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
* Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
* Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1
* Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
* Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
* Any previous treatment with fostamatinib

Primary outcomes:
measure: To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured
timeFrame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose
Secondary outcomes:
measure: To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured
timeFrame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose
measure: To examine the safety and tolerability of fostamatinib in combination with rifampicin.
timeFrame: From screening, Day 1 - Day 25, up to follow up visit
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
References:
Clinical trial NCT06731218: Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients with Type 1 Diabetes Mellitus
Official title: A Single-Center, Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus
Lead sponsor: Hangzhou Reprogenix Bioscience, Inc
Sponsor class: INDUSTRY
First posted: 2024-12-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase I clinical trial is a single-center, single-arm, open-label study aimed at evaluating the safety and therapeutic efficacy of RGB-5088 islet cell transplantation in patients with Type 1 Diabetes Mellitus.


Eligibility criteria: Key Inclusion Criteria:

* Age: 18-60 years old (including 18 and 60 years old), male and female;
* Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney);
* Stimulated C-peptide \< 0.3 ng/mL;
* The patient had at least one severe hypoglycemia within 12 months before being included in the project

Key Exclusion Criteria:

* Type 2 diabetes patients;
* Untreated proliferative diabetes retinopathy;
* Serious heart disease;
* Serious gastrointestinal dysfunction ；
* Serious psychological diseases；
* Any history of malignancy;
* Have a history of tobacco, alcohol and drug abuse;
* For female subjects: pregnancy test positive, lactation or unwilling to use effective contraceptive measures during the study period, male patients: intent to procreate or unwilling to use effective contraceptive measures during the study period.

Primary outcomes:
measure: Safety as assessed by number of subjects with adverse events
timeFrame: From RGB-5088 transplantation to one year later
measure: Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events
timeFrame: From 90 days to 365 days after RGB-5088 transplantation
Secondary outcomes:
measure: Safety as assessed by number of subjects with adverse events
timeFrame: From RGB-5088 transplantation to end of study (up to 5 years)
measure: Proportion of subjects who are insulin independent
timeFrame: From 90 days to end of study (up to 5 years)
measure: Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events
timeFrame: From 90 days to end of study (up to 5 years)
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin First Center Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT04750018: Influence of Co-Vid 19 Pandemic on Screening Mammography Single Institution
Official title: Influence of Co-Vid 19 Pandemic on Screening Mammography in a Single Institution
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Breast Cancer
Keywords: COVID-19
Breast Cancer
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 600
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The test period of the COVID-19 pandemic was between January 1 and July 31, 2020. Moreover, the control period of the pre-COVID-19 pandemic was between January 1 and July 31, 2019, before there was any report about the virus. Only patients with complete medical records were eligible for enrollment in this study. Confirmed COVID-19 case numbers in Taiwan were acquired from Taiwan's National Health Command Center \[7\]. Anonymized records of breast biopsies and cancer registration in a single institution in southern Taiwan in the pre-COVID-19 and COVID-19 periods were reviewed.

Brief summary: To assess whether the COVID-19 pandemic delayed breast cancer diagnosis in Taiwan, an Asian country with a low COVID-19 incidence.

Detailed description: The institutional review board approved this retrospective study at a public academic medical center. The monthly volume of breast biopsies and breast cancers during the COVID-19 pandemic (between January 1 and July 31, 2020) was compared to the same period a year earlier (pre-COVID-19).

Eligibility criteria: Inclusion Criteria:

* Receiving breast exam 2019-2020

Exclusion Criteria:

* lost clinical follow-up

Primary outcomes:
measure: breast cancer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Radiology depart
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Chen-Pin Chou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chou CP, Pan HB, Yang TL, Chiang CL, Huang JS, Tsai MY. Impact of the COVID-19 pandemic on the volume of mammography examinations in Southern Taiwan. Breast J. 2021 Jan;27(1):89-91. doi: 10.1111/tbj.14019. Epub 2020 Aug 20. No abstract available.
citation: Chou CP, Lin HS. Delayed Breast Cancer Detection in an Asian Country (Taiwan) with Low COVID-19 Incidence. Cancer Manag Res. 2021 Jul 28;13:5899-5906. doi: 10.2147/CMAR.S314282. eCollection 2021.
Clinical trial NCT02061618: Culturally Relevant Exercise for Diabetes (CURE-D)
Official title: Culturally Relevant Exercise for Diabetes (CURE-D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: South Asian
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Culturally Relevant Exercise for Diabetes (CURE-D) study will determine whether a culturally-sensitive dance intervention is an accepted and effective physical intervention for South Asian women with type 2 diabetes mellitus. The CURE-D study will determine if Bollywood dance exercise improves diabetes outcomes in South Asian women.


Eligibility criteria: Inclusion Criteria:

* Sex: Females
* Ethnicity: South Asian
* Hemoglobin A1c ≥ 6.0 mg/dL
* A PAMF patient for ≥ 24 months
* Able and willing to enroll and meet the requirements of the study.

Exclusion Criteria:

* BMI \> 35
* Insulin dependent
* Current atrial fibrillation
* Active treatment for cancer
* Diagnosis of a terminal illness and/or in hospice care
* Any serious medical condition which would prevent long-term participation or which would contraindicate physical activity
* Pregnant, lactating, or planning to become pregnant during the study period
* Inability to speak, read, or understand English
* No longer a PAMF patient or planning to transfer care outside of PAMF during the study period
* Investigator discretion for clinical safety or protocol adherence reasons.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Baseline
measure: Hemoglobin A1c
timeFrame: 8-week follow-up
Secondary outcomes:
measure: Body Mass Index
timeFrame: Baseline, 8-week follow-up
measure: Blood Pressure
timeFrame: Baseline, 8-week follow-up
measure: Physical Activity
timeFrame: Baseline, 8-week follow-up
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
Study officials:
References:
citation: Natesan A, Nimbal VC, Ivey SL, Wang EJ, Madsen KA, Palaniappan LP. Engaging South Asian women with type 2 diabetes in a culturally relevant exercise intervention: a randomized controlled trial. BMJ Open Diabetes Res Care. 2015 Oct 28;3(1):e000126. doi: 10.1136/bmjdrc-2015-000126. eCollection 2015.
Clinical trial NCT04200118: Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment
Official title: Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Male Infertility
Cancer
Epigenetic Disorder
Keywords: Sperm DNA fragmentation
Sperm epigenetics
Testicular cancer
Lead sponsor: IVI Barcelona
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sperm samples before treatment will be used as a control

Brief summary: The prognosis in cancer patients has improved over the years. Survivor rates have increased significantly, and paternity has become an important concern in more than 50% of young male survivors. Sperm cryopreservation before cancer treatment is highly recommendable in these patients, as a strategy to preserve their fertility due to is not possible to predict how the chemo or radiotherapy treatment will affect the spermatogenesis.

The objective of this study is to evaluate if sperm after an antineoplastic treatment can be safely used. To determine the possible effects of oncological treatments in the spermatogenesis, three parameters will be analyzed, aneuploidy frequencies, DNA fragmentation in single and double-strand breaks and methylation levels to determine epigenetic changes before and after the therapy.

If cancer treatment affect sperm genetic integrity, it would have a clinical impact in the offspring of these patients. Identify the different side effects of antineoplastic treatments in DNA sperm will provide a clinical improvement in order to select the best sperm sample in an IVF treatment and it will facilitate genetic counseling


Eligibility criteria: Inclusion Criteria:

Patients with previous history of cancer Patients with several sperm samples cryopreserved to be able to thaw a part without damaging their future options, in case they need them.

Patients treated with chemotherapy and/or radiotherapy Patients have finished their oncological treatment. Patints recovered spermatogenesis after the oncological treatment to be able to obtain a sperm sample.

Exclusion Criteria:

Patients with only one sperm sample cryopreserved Patients that are not be able to obtain a fresh sample post treatment Patients with less than 3 million sperm per milliliter

Primary outcomes:
measure: Epigenetic profile of the patient
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Ivi Barcelona
city: Barcelona
country: Spain
facility: IVI Barcelona
Study officials:
References: