louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06896006: Epidemiological Study of Out-of-hospital Cardiac Arrest in Shenzhen
Official title: Epidemiological Study of Out-of-hospital Cardiac Arrest in Shenzhen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out-Of-Hospital Cardiac Arrest
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 19672
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data source consists of ambulance dispatch records and prehospital medical records documented by the Shenzhen Emergency Medical Center from 2011 to 2018.

Brief summary: The epidemiology of out-of-hospital cardiac arrest (OHCA) is a significant public health issue, and large-sample studies on such events within China are relatively limited. This study utilizes the Utstein model to evaluate and analyze the epidemiological characteristics of OHCA in Shenzhen from 2011 to 2018. By reviewing ambulance dispatch records and prehospital medical records from the Shenzhen Emergency Medical Center between 2011 and 2018, the study analyzed epidemiological characteristics and reported the results. The main indicators of the study include demographic characteristics such as the gender, age, location of occurrence, key time points, vital signs, chief complaints, and diagnoses of the cases. It also covers prehospital emergency treatment processes, including whether bystanders performed CPR, initial electrocardiogram results, intravenous access establishment, use of epinephrine, defibrillation, tracheal intubation, and other interventions, as well as the outcomes of resuscitation.


Eligibility criteria: Inclusion Criteria:

* Cases with secondary diagnoses containing only the diagnostic keywords "cardiac arrest" and "sudden death"

Exclusion Criteria:

* 1. Cases with suicide, drowning, advanced cancer, trauma, shock, poisoning, cerebrovascular accidents, etc. 2.Cases with duplicate records for gender, age, time of call, pick-up and drop-off address, and initial diagnosis.

Primary outcomes:
measure: Crude incidence rate
timeFrame: 2011-01-01 to 2018-12-31
measure: Age standardized incidence rate
timeFrame: 2011-01-01 to 2018-12-31
measure: Annual percentage change
timeFrame: 2011-01-01 to 2018-12-31
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03711006: The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis
Official title: The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis - A Case Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis
Keywords: Fecal Microbiota Transplantation
Lead sponsor: Aleris-Hamlet Hospitaler København
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The trial is an open-label pilot study treating 7 patients with Ulcerative Colitis with 25 daily multi-donor FMT Capsules for 50 days with 6 months follow up including the treatment period
Primary purpose: TREATMENT

Brief summary: 7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days.

Detailed description: 7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days All patients are followed with regular follow up after 2,4,8,12,16, 20 and 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Ulcerative Colitis (UC)
* SCCAI between 4 and 10 at inclusion
* On a stable dose of 5-aminosalicylic acid (5-ASA) or without current treatment.
* Previous treatment with glucocorticoids, thiopurines and/or biological treatment was accepted.
* Fecal Calprotectin \> 250 mg/kg
* Colonoscopy performed within the last 3 years
* Capable of writing and speaking Danish
* Attending regular follow-ups by a specialist in gastroenterology.

Exclusion Criteria:

* Biological treatment within the last four weeks
* Treatment with antibiotics within 48 hours before intervention
* Alcohol use above current Danish guidelines (14 units/week for men and 7 units/week for women)
* Pregnancy or planned pregnancy
* Active cancer disease
* Medical treatment of mental disorder
* Other chronic gastroenterological disorder besides UC, Irritable Bowel Syndrome (IBS) or Reflux-disease.

Primary outcomes:
measure: Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI)
timeFrame: Baseline, 2,8,16 and 24 weeks
Secondary outcomes:
measure: Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity
timeFrame: Baseline
measure: Fecal microbiota biodiversity in fecal donors
timeFrame: At donor inclusion
measure: Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline
timeFrame: 8, 16 and 24 weeks
measure: Changes in Fecal Calprotectin in the active treatment period and follow-up period
timeFrame: Baseline, 8,16 and 24 weeks
measure: Changes in patient reported quality of life: IBDQ
timeFrame: Baseline, 8, 16 and 24 weeks
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: Aleris-Hamlet Hospital Copenhagen
Study officials:
affiliation: Aleris-Hamlet Hospitals Copenhagen
name: Alice H Christensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01306006: The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age
Official title: The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mortality
Vaccines
Keywords: Mortality
Vaccines
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
Collaborators: name: Institudo Nacional de Saude Publica INASA
First posted: 2011-03-01
Enrollment: 3500
Sex: ALL
Minimum age (years): 9
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The national Expanded Programme on Immunization (EPI) in Guinea-Bissau focuses its efforts exclusively on children below 12 months of age; children who have reached 12 months of age are no longer entitled to vaccines through the EPI program. This has affected the measles vaccination coverage, approx. 30% of the children in the rural area do not receive measles vaccine (MV).

Studies from the Bandim Health Project (BHP) have shown that MV has a profound impact on survival, reducing mortality by approximately 50% - far more than can be explained by prevention of measles deaths. Hence, MV seems to have non-specific beneficial effects on survival, and the current policy may have important consequences for overall child mortality.

To test the implications of the current policy of only vaccinating children below 12 months of age, the investigators will conduct a cluster randomized trial, in which children will receive their vaccines according to the current national EPI policy (National policy) or receive MV regardless of age and whether some doses of MV may be lost (MV-for-all policy).

The investigators hypothesise that among children enrolled after 12 months of age, mortality is 50% lower in children randomised to receive MV compared with children randomised to follow the national policy and not receive MV.


Eligibility criteria: Inclusion Criteria:

* Age 9-35 months, not yet received routine measles vaccination, resident in study area

Exclusion Criteria:

* To ill to be vaccinated (according to local practice)

Primary outcomes:
measure: Mortality
Secondary outcomes:
measure: Hospital morbidity
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project
Study officials:
References:
citation: Byberg S, Aaby P, Rodrigues A, Stabell Benn C, Fisker AB. The mortality effects of disregarding the strategy to save doses of measles vaccine: a cluster-randomised trial in Guinea-Bissau. BMJ Glob Health. 2021 May;6(5):e004328. doi: 10.1136/bmjgh-2020-004328.
Clinical trial NCT05498506: Multiple Firings in Double-stapled Colorectal Anastomosis
Official title: Risk Factors for the Usage of ≥3 Linear Stapler Cartridges During Double Stapling Anastomosis in Laparoscopic Low Anterior Resection of Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent Laparoscopic anterior resection for mid-low rectal cancer at Ruijin Hospital, Shanghai, People's Republic of China, between 2016 and 2021.

Brief summary: Multiple linear stapler firings during double stapling technique (DST) is associated with anastomotic leakage (AL) after laparoscopic low anterior resection (LAR). We aim to investigate the risk factors and then to develop a deep learning model to predict the usage of ≥3 linear stapler cartridges during DST anastomosis.


Eligibility criteria: Inclusion Criteria:

* 1) carcinoma of rectum confirmed by histopathological evaluation;
* 2) tumor located in the mid-low rectum (less than 10cm from the anal verge);
* 3) performance of DST anastomosis;
* 4) pelvic MRI obtained within 14 days before surgery.

Exclusion Criteria:

* 1) other anastomotic techniques (e.g., trans-anal rectal excision);
* 2) Hartmann's operation or other procedures without anastomosis;
* 3) the number of linear stapler cartridges was not traceable in the operative report.

Primary outcomes:
measure: the number of linear stapler cartridges
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
References:
Clinical trial NCT02988206: Personalized Objects Can Improve the Diagnosis of EMCS From MCS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients in Minimally Conscious State
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 21
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this study，researchers will use personalized objects to assess patients' level of consciousness in chronic patients in minimally conscious state (MCS).

Detailed description: The Coma Recovery Scale-Revised (CRS-R) is an important tool for the assessment of behaviors in DOC.Clinical practice has shown that self-referential stimuli, such as the patient's own name and face, are more effective to elicit the patient's response than that of non-self-referential stimuli.

The item "Functional Object Use" was assessed by using personalized objects (e.g., cigarette, paper) and non-personalized objects, which presented in a random order.The rest assessments were performed following the standard protocol of CRS-R. The differences between functional use of the two types of objects was analyzed by Chi-square test.

Researchers expected to see some of the patients in MCS are re-diagnosed as EMCS with the using of personalized objects.

Eligibility criteria: Inclusion Criteria:

* patients in minimally conscious state;
* patients with stable condition;
* each patient has athletic ability to some extent.

Exclusion Criteria:

* premorbid neurology antecedent;
* patients in coma or vegetative state;
* patients \< 1 months after the acute brain injury.

Primary outcomes:
measure: The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sun Y, Wang J, Heine L, Huang W, Wang J, Hu N, Hu X, Fang X, Huang S, Laureys S, Di H. Personalized objects can optimize the diagnosis of EMCS in the assessment of functional object use in the CRS-R: a double blind, randomized clinical trial. BMC Neurol. 2018 Apr 12;18(1):38. doi: 10.1186/s12883-018-1040-5.
Clinical trial NCT02616406: Objective Measure of Recovery After Outpatient Surgery
Official title: Assessment of Physical Activity to Determine When Patients Return to Baseline Levels of Activity Following Outpatient Inguinal Hernia Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Inguinal
Convalescence
Keywords: recovery of function
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2015-11-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with inguinal hernia who are to have hernia repair

Brief summary: This is a study using wearable monitoring devices, patient activity and sleep patterns to monitor pre and post operative following outpatient inguinal hernia surgery to determine when these parameters return to baseline.


Eligibility criteria: Inclusion Criteria:

* Patients presenting for outpatient inguinal hernia repair without significant medical comorbidities
* Patients who consent to participating and willing to wear device for designated time period per protocol

Exclusion Criteria:

* History of chronic opioid use
* Inability to speak English
* Inability to give informed consent

Primary outcomes:
measure: Determine time of return to baseline activity following elective outpatient hernia repair using wearable accelerometers that measure physical movement.
timeFrame: 8 weeks
Secondary outcomes:
measure: Determine pain levels on visual analog scale after outpatient hernia repair via telephonic questionnaire.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Karl A. Poterack, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05316506: Pain and Hysteroscopy
Official title: Choose Your Words Wisely: Impact of a Provider's Language on Perceived Pain During Office Hysteroscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysteroscopy Surgery
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy.


Eligibility criteria: Inclusion Criteria:

1. Adults 18 years of age and older
2. Scheduled for in office hysteroscopy
3. Able to consent for the study in English or Spanish

Exclusion Criteria:

1. Persons with preexisting conditions that may alter pain perception (ie. active vulvo-vaginal infection, vulvodynia, genital lesions, chronic pain conditions)
2. Previous in-office hysteroscopy
3. Hysteroscopy for foreign body/ Intrauterine Device (IUD) removal
4. Minors, prisoners, or other members of vulnerable populations
5. Patients who cannot communicate in English or Spanish

Primary outcomes:
measure: Change in Pain as measured by Visual Analog Scale (VAS)
timeFrame: Baseline (pre-procedure), Day 1 (post-procedure)
Secondary outcomes:
measure: Number of participants in each pain category
timeFrame: Day 1 (post-procedure)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Jose Carugno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02005406: Testing the Efficacy and Safety of the WEI Nasal Jet
Official title: Efficacy and Safety of the WEI Nasal Jet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Surgical Procedure
Keywords: Wei JET
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2013-12-09
Enrollment: 49
Sex: ALL
Minimum age (years): 22
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Suggested patient inclusion criteria:

Patients receiving various types of surgeries under sedation, especially for procedures of colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in the study.

Brief summary: Testing the efficacy and safety of the WEI Nasal Jet.

Detailed description: This is only initial thought and suggestions from the inventor Dr. Huafeng Wei. Principal investigator from each medical center interested in testing this new device should design their own clinical trials based on patient population and their own ideas for clinical trials. Just remind you that patient safety is number one and try all efforts to minimize patient risks during your clinical study.

Eligibility criteria: Inclusion Criteria:

* Patients receiving various types of surgeries under sedation, especially for procedures of colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in the study.

Exclusion Criteria:

* Patients with coagulopathy and tendency of nose bleeding.
* Patients with any diagnosed cardiac diseases (e.g. cardiac failure, angina, MI, cardiac arrhythmia. etc.)
* Patients with any diagnosed pulmonary disease (e.g. asthma, COPD, pulmonary embolism, pulmonary edema etc.)
* Pregnant patients
* Patients with liver failure
* Patients with kidney failure

Primary outcomes:
measure: lowest SaO2 in Wei JET group
timeFrame: 2 second
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Zeyong Yang, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang ZY, Meng Q, Xu YH, Wang JW, Yu DS, Wei HF. Supraglottic jet oxygenation and ventilation during colonoscopy under monitored anesthesia care: a controlled randomized clinical trial. Eur Rev Med Pharmacol Sci. 2016;20(6):1168-73.
Clinical trial NCT05528406: A Phase II Clinical Trial to Evaluate HLX208 in Advanced Solid Tumor Patients With BRAF V600 Mutation
Official title: An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Solid Tumor
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2022-09-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 Mutation


Eligibility criteria: Inclusion Criteria:

* Age\>=18Y
* Good Organ Function
* Expected survival time ≥ 3 months
* advanced solid tumors with BRAF V600 mutation that have been diagnosed
* Previous failure to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
* ECOG score 0-1;

Exclusion Criteria:

* Previous treatment with BRAF inhibitors or MEK inhibitors
* Symptomatic brain or meningeal metastases (unless the patient has beenon \> treatment for 6 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable)
* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin
* Patient with non-small cell lung cancer, anaplastic thyroid cancer, malignant primary intracranial tumor, melanoma, colorectal cancer or hematological tumor（Vulva and vaginal melanoma are excluded.）
* Severe active infections requiring systemic anti-infective therapy

Primary outcomes:
measure: ORR
timeFrame: from first dose to the last patient was followed up for 6 month
Secondary outcomes:
measure: PFS
timeFrame: [Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years]
measure: DOR
timeFrame: [Time Frame: from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first) assessed up to 1 years]
measure: OS
timeFrame: [Time Frame: from the first dose to the time of death due to any cause，assessed up to 2 years]
Other outcomes:
Locations:
Study officials:
References: