louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04923828: Chinese PICU Collaborative Network on Pathogens and Drug Resistance of Severe Infections
Official title: Children's Hospital of Fudan University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Infection
Keywords: PICU
pathogen
severs infection
drug resistance
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Hospital
name: Shanghai Children's Medical Center
name: Ningbo Women & Children's Hospital
name: Anhui Provincial Children's Hospital
name: Xian Children's Hospital
name: The Children's Hospital of Zhejiang University School of Medicine
name: Qilu Children's Hospital of Shandong University
First posted: 2021-06-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: PICU patients with severe infection

Brief summary: To investigate PICUs in major cities in China by establishing a high-quality standardized clinical database of PICU inpatients Incidence, fatality rate, pathogen distribution, anti-infective treatment of community-acquired/nosocomial infections in inpatients.

Detailed description: All patients admitted to the PICU during January 1, 2016 to December 31 2025 were included in the study, and all patients were followed up until death or PICU withdrawal. To establish the standardized Access database collected patients' general information, infection, PICU treatment, catheter, and short-term Prognosis and other clinical data.

Eligibility criteria: Inclusion Criteria:

* PICU patients with severe infection

Exclusion Criteria:

* Non-infected patient

Primary outcomes:
measure: Pathogenic spectrum of PICU severe infection
timeFrame: 2016-2025
Secondary outcomes:
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: Guoping Lu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01149928: Role of Cord Blood Hormones and Epinephrine in the Development of Transient Tachypnea of the Newborn
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Lung
Keywords: Fetal lung fluid
Pulmonary adaptation
Transient tachypnea of the newborn
Epinephrine
Stress hormones
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2010-06-24
Enrollment: 70
Sex: ALL
Minimum age (years): 34
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cesarean delivered, late preterm and term infants during the study period in Maternity Center of Ankara University

Brief summary: In this prospective, cross-sectional study, the aim was to investigate the possible role of cord stress hormones; adrenocorticotropic hormone (ACTH), cortisol, epinephrine, sT3, sT4, and thyroid-stimulating hormone (TSH) in the development of Transient Tachypnea of the Newborn (TTN), via their modulatory effect on epithelial sodium channels and Na-K-ATPase.


Eligibility criteria: Inclusion Criteria:

* Gestation age \> 34 weeks
* C/S delivered infants
* Parental consent form signed

Exclusion Criteria:

* Gestation age \< 34 weeks
* Maternal conditions that compromised fetal well-being (hypertensive disorder, diabetes, chorioamnionitis)
* Intrauterine growth retardation
* Congenital malformations
* Absence of parental consent

Primary outcomes:
measure: Stress response at birth, as demonstrated by cord cortisol, adrenocorticotropic hormone, epinephrine, fT3, fT4, and thyroid-stimulating hormone in late preterm and term neonates developing transient tachypnea of the newborn.
timeFrame: postnatal first 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Atasay B, Ergun H, Okulu E, Mungan Akin I, Arsan S. The association between cord hormones and transient tachypnea of newborn in late preterm and term neonates who were delivered by cesarean section. J Matern Fetal Neonatal Med. 2013 Jun;26(9):877-80. doi: 10.3109/14767058.2013.765846. Epub 2013 Feb 8.
Clinical trial NCT00000328: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III) - 3
Official title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Heroin Dependence
Opioid-Related Disorders
Keywords: drug dependence
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.

Detailed description: S/A brief "Summary for the Public"

Eligibility criteria: Inclusion Criteria:

Individuals must be at least 18 years of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.

Exclusion Criteria:

Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Primary outcomes:
measure: Drug use
measure: Retention
measure: Opioid agonist rating
measure: Opioid antagonist rating
measure: Compliance
measure: Medication identification
measure: Addiction Severity Index (ASI) Composite Score Rating
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leslie Amass, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02583828: Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Neoplasm Metastasis
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic breast cancers patients with estrogen receptor positive and/or progesterone receptor positive;
* Elderly women (age ≥ 65years)
* Failure or relapse from standard chemotherapy or unfit for chemotherapy
* Measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST);
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Adequate bone marrow, liver and renal function;
* Estimated life expectancy of at least 3 months.

Exclusion Criteria:

* Serious or uncontrolled concurrent medical illness
* Uncontrolled primary and metastatic brain tumor
* History of second primary malignancies
* Having been enrolled in other clinical trials within a month

Primary outcomes:
measure: Progression free survival(PFS) of the subjects
timeFrame: up to approximately 2 years
Secondary outcomes:
measure: Safety of each treatment regimen for the subjects
timeFrame: up to approximately 2 years
measure: Evaluate the quality of life for the subjects in the each treatment regimen
timeFrame: up to approximately 2 years
measure: Compare disease control rate for the subjects
timeFrame: up to approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital
Study officials:
References:
Clinical trial NCT02824861: Bemobile Intervention to Support Physical Activity in Cancer Survivors
Official title: Bemobile: A Text Intervention to Support Physical Activity in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 70
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates a technology based intervention (physical activity tracker, text messages, health coach, global positioning system enabled location based feedback on physical activity) to support physical activity in cancer survivors after completing oncology rehabilitation. In Phase 1 all participants received the full intervention. In phase II participants are randomly assigned to receive the full intervention or a fitbit only.

Detailed description: This intervention, offered to participants after completing oncology rehabilitation, integrates known preferences and determinants of physical activity participation in women and breast cancers survivors including social support, professional guidance, self-efficacy, goal setting, self-regulation, and environmental awareness delivered through accessible technology. For the iteration phase, the investigators will conduct an initial, abbreviated intervention wave lasting 4 weeks; the investigators will then incorporate participant input and feedback on the specific components to refine the intervention prior to a pilot trial. Means of delivering the components include communication and support through tailored text messaging, health coaching phone calls, self-monitoring of physical activity through a wearable sensor, and environmental assessment of community physical activity options (e.g., parks, fitness centers, trails) based on global positioning system information.

Eligibility criteria: Inclusion Criteria:

* Cancer diagnosis
* Impending graduation from oncology rehabilitation

Exclusion Criteria:

* Metastatic cancer
* Concurrent radiation or chemotherapy
* No cell phone
* Inability to read or speak English.

Primary outcomes:
measure: Change from Baseline in Step counts
timeFrame: 8 weeks
measure: Change from Baseline in Moderate to Vigorous Physical Activity (MVPA)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Weekly average of mean daily step counts
timeFrame: 8 weeks
measure: Change from Baseline in Self-efficacy to perform exercise
timeFrame: 8 weeks
measure: Change from Baseline in Self-regulation
timeFrame: 8 weeks
measure: Change from Baseline in Fatigue
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT03307161: Osteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia
Official title: Osteopathic Manual Treatment of Postural Abnormality, Pain, and Autonomic Control of Cardiac Function in People With Parkinson's Disease and Truncal Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Dystonia
Autonomic Dysreflexia
Keywords: manual therapy
heart rate
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will determine if posture and heart rate variability will significantly improve in Parkinsons disease with camptocormia after osteopathic manual treatments dystonia.

Detailed description: This study will determine if posture and heart rate variability will significantly improve in Parkinsons disease with camptocormia after receiving 8-weekly sessions of the osteopathic manual treatments for truncal flexion dystonia as measured by the distance of the external acoustic meatus from a plumb-line to lateral malleolus, spinal X ray, and heart rate variability.

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease; able to stand for three minutes or more

Exclusion Criteria:

* severe dementia, moderate or severe hallucinations and psychosis; unable to stand for three minutes

Primary outcomes:
measure: change in posture
timeFrame: 8 weeks
measure: change in heart rate variability
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology
state: New York
Study officials:
affiliation: NYIT col osteopathic medicine
name: Jayme Mancini, PhD DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02207361: Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer
Official title: A Randomized Prospective Clinical Trial of Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Metastatic Breast Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 120
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: Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Detailed description: A Randomized Prospective Clinical Trial of Paclitaxel in Combination with Carboplatin Versus Paclitaxel plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Eligibility criteria: Inclusion Criteria:

* female ≥ 18 years old, ECOG 0-2 or KPS≥60, Expected lifetime more than 12 weeks.

Exclusion Criteria:

* Pregnancy, Paclitaxel, platinum and anthracycline-based drugs' allergy, Severe Infection.

Primary outcomes:
measure: RECIST 1.1
timeFrame: -7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Zhongsheng Tong, Master
role: STUDY_DIRECTOR
References:
citation: Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.
Clinical trial NCT02389361: Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol
Official title: ZIH Study : Comparison of Oral Zaldiar (Combination of Paracetamol and Tramadol) With Intravenous Paracetamol and Tramadol for Postoperative Analgesia After Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol).

Detailed description: Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. This is the classical approach. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol). This is the new approach.

Eligibility criteria: Inclusion Criteria:

* All patients incoming for inguinal hernia repair

Exclusion Criteria:

* Preoperative abuse of analgesics

Primary outcomes:
measure: Acute Pain
timeFrame: In recovery room
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Astes
name: Eric Deflandre
role: STUDY_DIRECTOR
References:
Clinical trial NCT06844461: Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma
Official title: Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life Outcomes
Acoustic Schwannoma
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled at the outpatient clinic of an Otolaryngology and Audiology Unit and Neurosurgery Unit of two third level university hospitals in Northern Italy with acoustic neuroma diagnosis between 01/01/2000 and 31/10/2022.

Brief summary: Italian translation and validation study of two different questionnaire (VSQOL and DRS) about quality of life in patient with acoustic schwannoma.


Eligibility criteria: Inclusion Criteria:

* Patient with sporadic acoustic neuroma in follow-up with wait and scan protocol or treated with microsurgical resection with any approach

Exclusion Criteria:

* Patient with NF2
* Patient previuosly treated with RT in the head and neck district
* Patient with pre-treatment facial palsy ipsi and controlateral
* Patient non native italian speakers
* Patient with major mental illness already existing before the acoustic neuroma diagnosis
* Patient with neurological issues such as chronic migraine or postural instability already existing before the acoustic neuroma diagnosis

Primary outcomes:
measure: VSQOL-It
timeFrame: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
measure: DRS-It
timeFrame: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
Secondary outcomes:
measure: PANQOL
timeFrame: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
measure: DASS-21 Questionnaire
timeFrame: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Irccs Aou Bologna
Study officials:
References:
Clinical trial NCT02862561: Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer
Official title: Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Precision Cell Immunotherapy
Chemotherapy
Advanced Malignancies
Keywords: Precision Cell Immunotherapy
Chemotherapy
Advanced Malignancies
Lead sponsor: Shanghai International Medical Center
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives:

To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Gastric Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Gastric Cancer.

Detailed description: A total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility criteria: Inclusion Criteria:

* Age 18\~65 years old, male or female;
* Life expectancy≥6 months;
* ECOG score: 0-3;
* Advanced Malignancies (gastric cancer) were diagnosed by pathological or clinical physicians;
* Enough venous channel, no other contraindications to the separation and collection of white blood cells;
* Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x 10\*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
* Signed informed consent;
* Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

* Expected Overall survival \< 6 months;
* Patients with uncontrolled hypertension (\>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months;
* Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
* Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month;
* Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Progress-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai International Medical Center
state: Shanghai
Study officials:
affiliation: Shanghai International Medical Center
name: Naiyan Han
role: STUDY_CHAIR
References:
Clinical trial NCT02863861: Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients
Official title: Comparative Study Between Propofol-Ketamine Combination and Dexmedetomidine-Ketamine Combination for Sedation in Upper Gastrointestinal Endoscopy in Paediatric Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper Gastrointestinal Endoscopy
Keywords: Sedation
Pediatric Patients
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compere between Propofol-Ketamine combination and Dexmedetomidine-Ketamine combination for sedation in upper gastrointestinal endoscopy in paediatric patients.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists ASA I-II patients aging 2-7 years.

Exclusion Criteria:

known allergy to any of the study drugs, significant cardiovascular disease vomiting.

Primary outcomes:
measure: length of stay in PACU
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university- faculty of medicine- department of anesthesia, intensive care and pain management
Study officials:
References:
citation: Amer AM, Youssef AM, El-Ozairy HS, El-Hennawy AM. [Propofol-ketamine versus dexmedetomidine-ketamine for sedation during upper gastrointestinal endoscopy in pediatric patients: a randomized clinical trial]. Braz J Anesthesiol. 2020 Nov-Dec;70(6):620-626. doi: 10.1016/j.bjan.2020.08.005. Epub 2020 Dec 5.