louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02013765: A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer
Official title: An Open-label Pilot Study of the Effect of Second-line Treatment With Herceptin Monotherapy on Time to Disease Progression in Patients With Metastatic Urothelial Cancer and HER2 Overexpression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Urinary Tract Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* metastatic urothelial cancer;
* disease progression during or after 1 prior platinum-based chemotherapy;
* measurable disease;
* HER2 overexpression (IHC \[2+\] or \[3+\]).

Exclusion Criteria:

* concomitant chemotherapy or immunotherapy;
* active or uncontrolled infection;
* solely CNS metastases;
* clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
* co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.

Primary outcomes:
measure: Progression-Free Survival (PFS) - Percentage of Participants With an Event
timeFrame: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
measure: Progression-Free Survival - Time to Event
timeFrame: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
measure: Percentage of Participants Progression Free at 12 and 24 Months
timeFrame: Months 12 and 24
Secondary outcomes:
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter
measure: Overall Survival - Time to Event
timeFrame: Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter
measure: Percentage of Participants Surviving at 12 and 24 Months
timeFrame: Months 12 and 24
measure: Percentage of Participants by Best Overall Response to Treatment
timeFrame: Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment
Other outcomes:
Locations:
city: Aschersleben
country: Germany
city: Dessau
country: Germany
city: Fulda
country: Germany
city: Leipzig
country: Germany
city: Leipzig
country: Germany
city: Marburg
country: Germany
city: Weiden
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT00763165: Periodontal Disease and Cardiovascular Disease
Official title: Periodontal Disease and Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Periodontal Diseases
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To access the influence of triclosan dentifrice on the progression of periodontal disease in patients with coronary heart disease.


Eligibility criteria: Inclusion Criteria:

* A minimum of 12 uncrowned teeth other than 3rd molars
* Age 18 to 75 years
* Informed consent

Exclusion Criteria:

* Prosthetic heart valves
* Prosthetic joint replacement
* Previous infective endocarditis
* Requirement for antibiotic cover for dental treatment
* Current treatment with warfarin

Primary outcomes:
measure: Periodontal disease
timeFrame: 3-5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Chermside
country: Australia
facility: Discipline of Medicine
Study officials:
name: Gregory Seymour, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01003366: Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Catheterization
Keywords: safety during central venous catheterization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 338
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To test the hypothesis that approaching the internal jugular vein with the needle bevel down would produce less injury to the vessel wall compared to the bevel up approach during central venous catheterization.


Eligibility criteria: Inclusion Criteria:

* patients undergoing surgery that requires the placement of a central venous catheter at the internal jugular vein

Exclusion Criteria:

* anatomical anomaly in the neck region
* recent history of central venous catheterization

Primary outcomes:
measure: posterior wall puncture of internal jugular vein
timeFrame: immediately after catheterization
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06686966: The Effect of Environmental Pollution on the Prognosis of Gastric Cancer
Official title: Clinical Study on the Effect of Environmental Pollution on the Prognosis of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancers
Keywords: gastric cancer
air pollution
environment
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 3400
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: Patients diagnosed with gastric cancer and undergoing radical gastric cancer surgery at the First Hospital of Chongqing Medical University, the Second Hospital of Chongqing Medical University, and the Yongchuan Hospital of Chongqing Medical University.

Brief summary: Gastric cancer is one of the common malignant tumours worldwide, with a high incidence especially in East Asia. Although the occurrence of gastric cancer is closely related to genetic factors, lifestyle and dietary habits, in recent years, environmental pollution, especially air pollution, has received more and more attention as a potential carcinogenic factor. Numerous studies have shown that harmful substances in the air such as including passive smoking, soot and oil smoke exposure, incense burning exposure, occupational exposure and outdoor work, PM2.5, PM10, nitrogen oxides, sulphur dioxide, etc. may not only induce the occurrence of gastric cancer, but also affect the prognosis of gastric cancer patients. This experiment intends to determine the extent of the influence of air pollution on the prognosis of gastric cancer by analysing the survival data of gastric cancer patients in areas with different pollution levels. In addition, the association between air pollution levels and postoperative recurrence in gastric cancer patients was investigated to find possible mechanisms.


Eligibility criteria: Inclusion Criteria:

* patients aged ≥18 years;
* patients diagnosed with gastric cancer by pathological biopsy before surgery;
* patients without chemotherapy, radiotherapy, targeted and immunotherapy before enrolment;
* willing to participate in this study and sign the informed consent;
* complete clinical data.

Exclusion Criteria:

* patients with other primary malignant tumours other than gastric cancer;
* patients with systemic diseases such as severe cardiopulmonary insufficiency that affect the choice of treatment plan;
* patients who are not suitable for enrolment as assessed by the investigator;
* incomplete clinical data.

Primary outcomes:
measure: the incidence of gastric cancer
timeFrame: From 18 years old until the developing gastric cancer, through study completion, an average of 5 year.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04743466: Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes
Official title: Evaluation of a Causal Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes: A Mendelian Randomization Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anxiety Disorder
Depression
Genetic Disorder
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 700000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals have volunteered to participate in institutional or national biobanks

Brief summary: This study evaluates the association between testosterone levels and risk of dementia and adverse mental health outcomes (e.g. depression and anxiety). It is not known whether low testosterone levels may be associated with an increased risk of dementia. Learning about the association between testosterone levels and risk of dementia may help determine the long-term effects of androgen deprivation therapy and may help improve quality of life.

Detailed description: PRIMARY OBJECTIVE:

I. To use a Mendelian randomization study design to determine whether genetically predicted decreased testosterone levels are associated with an increased risk of dementia.

SECONDARY OBJECTIVE:

I. To examine whether genetically predicted decreased testosterone levels are associated with worse cognitive function and adverse mental health outcomes.

OUTLINE:

Patients' records from institutional or national biobanks are reviewed.

Eligibility criteria: Inclusion Criteria:

* Have volunteered to participate in institutional or national biobanks, mainly the UK Biobank and the Kaiser Permanente Research Bank, and those that have previously participated in studies that resulted in de-identified clinical and genetic data being make available on public archives, mainly the database of Genotypes and Phenotypes (dbGaP)
* No special populations (adults unable to consent, individuals not yet adults, pregnant women, or prisoners)

Primary outcomes:
measure: Association between germline genetic predictors (single nucleotide variants) of lower testosterone levels and dementia risk
timeFrame: Up to 2 years
Secondary outcomes:
measure: Depression
timeFrame: Up to 2 years
measure: Anxiety
timeFrame: Up to 2 years
measure: Cognitive/mental health
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kevin Nead
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06211166: Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction
Official title: Predicting Patient Relapse After Allogeneic Hematopoietic Stem Cell Transplantation: A Comparison of Measurable Residual Disease (MRD) Assessment by Digital Polymerase Chain Reaction and Conventional MRD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Leukemia
MDS
MDS/MPN
CML
Keywords: dPCR
MRD
allo-HSCT
leukemia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD monitoring peri-HSCT

Brief summary: A research investigation into the efficacy of digital Polymerase Chain Reaction (dPCR) for monitoring measurable residual disease (MRD) during allogeneic hematopoietic stem cell transplantation, with a focus on predicting relapse in patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions.

Detailed description: This prospective clinical study focuses on patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions post-allogeneic hematopoietic stem cell transplantation. The primary objective is to assess the efficacy of digital Polymerase Chain Reaction (dPCR) in monitoring measurable residual disease (MRD), including markers such as BCR::ABL, KMT2A, etc., as compared to other MRD monitoring methods such as conventional quantitative PCR or multicolor Flow Cytometry (MFC). Key endpoints include the recurrence of MRD using conventional methods, hematological relapse, disease-free survival, overall survival, and non-relapse mortality.

Eligibility criteria: Inclusion Criteria:

* The presence of at least one fusion gene or hematological tumor-associated mutation detected at diagnosis by NGS or real-time PCR provided for posttransplant MRD monitoring.
* Neutrophil engraftment
* Received at least one MRD monitoring by digital PCR after HSCT

Exclusion Criteria:

* Patients who relapsed or died before the first digital PCR monitoring
* Patients only with mutations in DNMT3A, TET2, and ASXL1 ("DTA mutations") or only germline mutations

Primary outcomes:
measure: Threshold of dPCR to predict conventional MRD
timeFrame: 2-year
Secondary outcomes:
measure: Cumulative incidence of relapse (CIR)
timeFrame: 2-year
measure: Overall survival (OS)
timeFrame: 2-year
measure: Relapse-free survival (RFS)
timeFrame: 2-year
measure: Non-Relapse Mortality(NRM)
timeFrame: 2-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xiao-jun Huang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04295265: Smartphone Message to Improve the Drug Compliance in Pregnant Women.
Official title: A Randomized Controlled Trial on the Use of Smartphone Message to Improve the Drug Compliance in Pregnant Women.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As technology advances, smartphones are now widely available and can provide a convenient and effective means to improve drug compliance by sending an electronic reminder on a regular basis. In a meta-analysis of 16 RCTs in assessing of drug compliance in chronic diseases, text message significantly improves medication compliance (OR, 2.11; 95% CI, 1.52-2.93; P \< 0.001). The drug compliance improves from 50% to 67.8%, or an absolute increase of 17.8%. Further evaluation is required as most of these RCTs relies on self-reported compliance. This data may be not applicable to pregnant women and trial of using this approach to improve drug compliance during pregnancy is lacking.

The investigators hypothesize that the use of smartphone message will improve the drug compliance in pregnant women requiring long term medications. The investigators propose a randomized controlled trial to evaluate the effect of smartphone message.


Eligibility criteria: Inclusion Criteria:

* All women age ≥ 18 years old
* Able to receive electronic reminder through smartphohne
* Gestational age less than 16 completed weeks as defined by pelvic ultrasound
* Part 1: Need to take aspirin or progesterone for prevention of pre-eclampsia or preterm birth respectively
* Part 2: Given multivitamin as health supplementation

Exclusion Criteria:

For Part 1:

* History of adverse reaction to aspirin
* History of adverse reaction to progesterone
* History of breast or genital tract malignancy
* History of suspected thromboembolic disease
* Congenital uterine anomaly
* Unwillingness or inability to comply with study procedures
* Known paternal or maternal abnormal karyotype

Primary outcomes:
measure: Compliance
timeFrame: through study completion, an average of 9months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02156765: China Atrial Fibrillation Screening in Acute Ischemic Stroke Patients
Official title: China Atrial Fibrillation Screening in Acute Ischemic Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Stroke
Keywords: Atrial Fibrillation
Screening
Stroke patients
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
First posted: 2014-06-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with ischemic stroke that are diagnosed definitely

Brief summary: Three purpose of this study:

1. Increase diagnosis rate and formulate the flow of diagnosis and treatment of AF in ischemic stroke patients;
2. Evaluation on specificity and sensitivity of STAF score;
3. Analyze the pathogenesis of ischemic stroke and risk factors and establish clinical database and sample database of ischemic stroke.

Detailed description: Inclusion criteria:

1. Hospitalized patients with ischemic stroke that are diagnosed definitely;
2. Age ≥ 18 years;
3. Within 7 days after the onset of diseases;
4. Signed the consent informed form.

Exclusion criteria:

1. Patients with noncerebrovascular diseases that are diagnosed definitely;
2. Silent cerebral infarction (CI) without symptoms and signs;
3. Those refuse to sign the consent informed form of the study.

Eligibility criteria: Inclusion Criteria:

1. Hospitalized patients with ischemic stroke that are diagnosed definitely;
2. Age ≥ 18 years;
3. Within 7 days after the onset of diseases;
4. Signed the consent informed form.

Exclusion Criteria:

1. Patients with noncerebrovascular diseases that are diagnosed definitely;
2. Silent cerebral infarction (CI) without symptoms and signs;
3. Those refuse to sign the consent informed form of the study.

Primary outcomes:
measure: Accumulated detection rate of AF
timeFrame: 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Stroke Association
state: Beijing
Study officials:
affiliation: Tiantan Hospital
name: yongjun wang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ay H, Furie KL, Singhal A, Smith WS, Sorensen AG, Koroshetz WJ. An evidence-based causative classification system for acute ischemic stroke. Ann Neurol. 2005 Nov;58(5):688-97. doi: 10.1002/ana.20617.
citation: Li SY, Yang XM, Zhao XQ, Liu LP, Wang YL, Jiang Y, Wang YJ. Newly detected atrial fibrillation is associated with cortex-involved ischemic stroke. Chin Med J (Engl). 2019 Sep 5;132(17):2053-2058. doi: 10.1097/CM9.0000000000000390.
citation: Yang X, Li S, Zhao X, Liu L, Jiang Y, Li Z, Wang Y, Wang Y. Atrial fibrillation is not uncommon among patients with ischemic stroke and transient ischemic stroke in China. BMC Neurol. 2017 Dec 4;17(1):207. doi: 10.1186/s12883-017-0987-y.
Clinical trial NCT02866266: ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
Official title: Extended Release (ER) / Long-acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) Assessment 5.1: Surveillance of Emergency Department Visits and Hospitalizations for Opioid Overdose and Poisoning Events
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid-related Disorders
Opioid Addiction
Narcotic Abuse
Drug Abuse
Lead sponsor: ER/LA Opioid REMS Program Companies (RPC)
Sponsor class: INDUSTRY
Collaborators: name: HealthCore, Inc.
First posted: 2016-08-15
Enrollment: 183452
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that receive at least one dispensing of an ER/LA opioid during at least one study REMS period with at least six months of prior continuous health plan eligibility in the main analyses. Additional analyses will consider patients enrolled in the HIRD or a participating Medicaid plan regardless of ER/LA opioid exposure.

Brief summary: Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

Detailed description: As part of the FDA-approved plan to evaluate the effects of the REMS program, the REMS Program Companies (RPC) are required to submit FDA assessment reports on a regular basis. The present study is one of several program evaluation components carried out in support Assessment 5: Surveillance monitoring for misuse, abuse, overdose, addiction, death and intervention taken. This study will evaluate the impact of the ER/LA opioid REMS program on the incidence of ED visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.

Eligibility criteria: Inclusion Criteria:

1. At least one dispensing of an ER/LA opioid after 01 July 2010
2. At least six months of continuous health plan eligibility prior to the first recorded dispensing of an opioid that occurs during an included REMS period

Exclusion Criteria:

1. Missing or implausible values for age
2. Missing or implausible values for gender

Primary outcomes:
measure: Number of ED visits for opioid overdose/poisoning and mortality
timeFrame: Retrospective review over period from July 2010 through December 2014
measure: Number of hospitalizations for opioid overdose/poisoning and mortality
timeFrame: Retrospective review over period from July 2010 through December 2014
Secondary outcomes:
measure: All-cause mortality
timeFrame: Retrospective review over period from July 2010 through December 2014
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00023166: Phase I Study of PEG-Paclitaxel In Patients With Advanced Solid Tumors & Lymphomas
Official title: Phase I Study of PEG-Paclitaxel In Patients With Advanced Solid Tumors and Lymphomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasm
Lymphomas
Neoplasm Metastasis
Keywords: Phase I
Open label
Safety/efficacy
Lymphomas
Advanced primary and/or metastatic solid tumors
Neoplasms
Neoplasm metastasis
Lead sponsor: Enzon Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2001-08-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Studies of PEG-paclitaxel have been terminated


Eligibility criteria: None - Study has been terminated.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: