louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01922453: Music and Sounds for ECV
Official title: Use of Music and Sounds for the External Cephalic Version of Breech Fetuses Near Term.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breech Presentation
Vertex Presentation
Keywords: breech presentation
vertex presentation
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This international study is looking to see if the addition of music and sound on the maternal abdomen encourages fetal position change from breech to vertex in near term women.


Eligibility criteria: Inclusion Criteria:

* pregnant women near term with breech presentation.

Exclusion Criteria:

* women with a contraindication for vaginal birth

Primary outcomes:
measure: vertex position
timeFrame: 3 days post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Hagit Daum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05058053: THE EFFECT OF COLD APPLICATION ON THE DEVELOPMENT OF PHLEBITIS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE TREATMENT.
Official title: INVESTIGATION OF THE EFFECT OF COLD APPLICATION ON THE DEVELOPMENT OF PHLEBITIS IN PATIENTS RECEIVING INTRAVENOUS AMIODARONE TREATMENT. A RANDOMIZED OPEN-LABEL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phlebitis
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study, which has a quasi-experimental, prospective, and open-label randomized controlled design, was conducted to examine the effect of cold application on the development of phlebitis in patients receiving IV amiodarone infusion treatment.

Study Hypotheses H0-1: There is no difference in the rate of development of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.

H0-2: There is no difference in the grade of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.

H0-3: There is no difference in the time of development of phlebitis between the patients who received and who did not receive cold application during amiodarone IV infusion.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18, who were planned to receive 300 mg amiodarone in 150 ccs of 5% dextrose + 900 mg amiodarone (maintenance) in 50 ccs of 5% Dextrose in 30 minutes (24 hour-infusion),
* Patients to whom PVC was placed in the upper extremity, and who did not develop phlebitis on the PVC site

Exclusion Criteria:

* Cold allergy/sensitivity or circulatory disorders
* During the study, patients who had a change in the IV amiodarone treatment protocol, whose IV amiodarone treatment was terminated before 24 hours, whose IV amiodarone treatment protocol was started, but PVC had to be replaced for any reason during the 24-hour period

Primary outcomes:
measure: the rate of development of phlebitis
timeFrame: 24+2 hours
Secondary outcomes:
measure: the grade of phlebitis
timeFrame: 24+2 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
Study officials:
References:
Clinical trial NCT01935453: A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer
Official title: A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Liver Cancer
Pancreatic Cancer
Lung Cancer
Lead sponsor: OrienGene Biotechnology Ltd.
Sponsor class: INDUSTRY
Collaborators: name: START Shanghai
name: Beijing Bozhiyin T&S Co., Ltd.
First posted: 2013-09-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.


Eligibility criteria: Inclusion Criteria:

* patients in advanced stage of malignant tumor diagnosticated by pathologic and cytological analysis.
* lack of routine effective treatment,failure of routine treatment or relapse
* age of 18-70,ECOG 0-2 and estimated survival is above 3 months
* had an interval of above 4 weeks since exposure to chemotherapy or radiotherapy and above 6 weeks since exposure to nitrosoureas or mitomycin C.

Exclusion Criteria:

* Serious internal diseases
* uncontrolled primary and metastatic brain tumor
* sizes of tumor does not meet the requirement of injection

Primary outcomes:
measure: Exploring the MTD of OrienX010 according to DLT,which defined as the serious degree of adverse events relates to the medicine not less than grade 3 of CTCAE v4.03
timeFrame: 28 days after the last administration
Secondary outcomes:
measure: Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010
timeFrame: 28 days after the last administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital,CMU
state: Beijing
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jin Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Shijitan Hospital,CMU
name: Jun Ren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06426953: Predictive Effect of TGF-β and INS-PI3K-AKT Related Proteins for POD in Diabetes Patients
Official title: Predictive Effect of TGF-β Combined With INS-PI3K-AKT Signaling Pathway Related Proteins (ADNP, MAP6, Pgc-1α) for POD in Diabetes Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Postoperative Delirium
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients with a history of diabetes ≥2 years and a glycated hemoglobin of ≥6.5% or without a history of diabetes and a normal blood glucose level

Brief summary: To investigate the relationship between POD, TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) in diabetic patients

Detailed description: The study was a two-center, prospective，single blind (blinded to subjects and evaluators)，control, observational clinical study. Participants will collect 3 milliliters of blood from enrolled patients before surgery begins. The collected blood samples were processed and stored in -80℃ refrigerator. All samples were tested TGF-β and INS-PI3K-AKT signaling pathway related proteins (ADNP, MAP6, PGC-1α) by ELISA.

Eligibility criteria: Inclusion Criteria:

1. Age ≥65 years
2. History of diabetes ≥2 years and Glycated hemoglobin ≥6.5% or no history of diabetes and normal blood glucose
3. The ASA rating is Class I to III
4. The elderly patients of limited thoracic and abdominal tumor surgery

Exclusion Criteria:

1. Refused to participate
2. Previous history of schizophrenia, epilepsy, Parkinson's disease
3. History of alcohol abuse or drug dependence
4. Patients with ASA grade IV and above
5. Severe visual or hearing impairment, can not cooperate with the completion of cognitive function tests
6. Participants in other clinical trials within the last two months
7. Patients with severe arrhythmia or cardiac dysfunction(EF\<40%)
8. There was a clear history of neurological and psychiatric problems or long-term use of sedatives or antidepressants
9. History of cerebrovascular disease or brain surgery or trauma
10. Severe liver dysfunction (Child-Pugh class C) or severe renal dysfunction (requiring dialysis)

Primary outcomes:
measure: The correlation between preoperative plasma levels of TGF-β, ADNP, MAP6, PGC-1α and the incidence of delirium within 3 days after operation was analyzed.
timeFrame: 2024-05 to 2026-06
Secondary outcomes:
Other outcomes:
Locations:
city: Duyun
country: China
facility: The People's hospital of Qiannan
state: Guizhou
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Kangjie Xie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01761253: Assessing Costs & Cost-variability Among Enrollees of Health Insurance Programs Utilizing Charlson's Comorbidity Index and Administrative Databases
Official title: Assessing Costs & Cost-variability Among Enrollees of Health Insurance Programs Utilizing Charlson's Comorbidity Index and Administrative Databases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Chronic Illnesses
Keywords: comorbidity, multiple chronic conditions, Medicaid, prediction of cost
Predictive models, cost containment, managed care
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 241000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 15,000 patients who were continuously enrolled during the calendar years 2006 and 2010 in the Generations Plus/ Northern Manhattan Health Network and 226,000 members of a large self insured union trust fund from 2007-2010 will be combined. The data will include age, gender, length of plan enrollment, whether or not the patient is disabled, their diagnoses, and their use of medical and social services.

Brief summary: This study will involve the evaluation of the cost profile of about approximately 241,000 patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network AND 226,000 members of a large self insured union trust fund). We will test the hypothesis that as comorbidity scores exceed three-four, patients will have an exponential increase in average yearly cost with a parallel exponential increase in cost variability.

We will examine the relationship between comorbidity and health insurance costs and variability in costs among patients enrolled in health plans.


Eligibility criteria: Inclusion Criteria:

* patients with different burdens of comorbidity who have at least two continuous years of enrollment in the Generations Plus/ Northern Manhattan Health Network between June 2007 to July 2009 and members of a large self insured union trust fund from 2007-2010

Primary outcomes:
measure: Assessing costs & cost-variability among enrollees of health insurance programs utilizing Charlson's comorbidity index and administrative databases
timeFrame: The data within this dataset was collected between July 2006 and July 2010.
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Generations Plus/ Northern Manhattan Health Network
state: New York
Study officials:
References:
citation: Charlson M, Wells MT, Ullman R, King F, Shmukler C. The Charlson comorbidity index can be used prospectively to identify patients who will incur high future costs. PLoS One. 2014 Dec 3;9(12):e112479. doi: 10.1371/journal.pone.0112479. eCollection 2014.
Clinical trial NCT05193253: Long-term Outcomes of Ablation, Liver Resection, and Liver Transplant as First-line Treatment for Solitary HCC of 3 cm or Less
Official title: Long-term Outcomes of Ablation, Liver Resection, and Liver Transplant as First-line Treatment for Solitary HCC of 3 cm or Less Using an Intention-to-treat Analysis: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: liver transplant
liver resection
radiofrequency ablation
hepatocellular carcinoma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 119
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: Adult (≥18 years) patients with solitary HCC ≤ 3cm who underwent either RFA, LR, or were listed for an LT between Feb-2000, and Nov-2018.

Brief summary: Curative-intent therapies for hepatocellular carcinoma (HCC) include radiofrequency ablation (RFA), liver resection (LR), and liver transplantation (LT). Controversy exists in treatment selection for early-stage tumors. We sought to evaluate the oncologic outcomes of patients who received either RFA, LR, or LT as first-line treatment for solitary HCC ≤ 3cm in an intention-to-treat analysis.


Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years) patients
* Solitary HCC ≤ 3cm
* Receipt of either radiofrequency ablation, liver resection, or listing for a liver transplant
* Treatment received between Feb-2000 and Nov-2018

Exclusion Criteria:

* Pathology other than hepatocellular carcinoma (HCC)
* Receipt of prior treatment (i.e., not treatment naive)
* Not eligible for all of the three treatments (ablation, liver resection, or liver transplant listing)
* Platelet count \<100,000 before treatment
* Alpha-1 fetoprotein (AFP) level \> 1000 before treatment
* Age \> 70 years
* Child-Pugh score C
* Esophageal varices grade greater than 2
* Model for End-stage Liver Disease (MELD) score before treatment exceeding 15
* Presence of ascites pretreatment
* Presence of encephalopathy pretreatment
* Spleen size greater than 12 cm

Primary outcomes:
measure: Intention-to-treat (ITT) overall survival
timeFrame: Overall (median length of follow up of entire cohort 6.6 years)
measure: Disease-free survival (DFS).
timeFrame: Overall (median length of follow up of entire cohort 6.6 years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01436253: Study of Lipid Control in Hyperlipidemic Participants (MK-0653-179)
Official title: Non-Interventional Study In Hyperlipidemic Patients Who Do Not Reach Satisfactory Lipid Values With Existing Hypolipemic Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 2196
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Croatian participants with inadequately controlled hyperlipidemia being treated in the primary care setting

Brief summary: This study is being done to see whether dietary and medicinal measures compliant with hyperlipidemia treatment guidelines will result in achieving target lipid values and to evaluate the total risk of cardiovascular disease in study participants who have not reached satisfactory lipid levels with their current hypolipemic therapy.


Eligibility criteria: Inclusion criteria:

* Hyperlipidemic
* On therapy for hyperlipidemia for \>=3 months without achieving target lipid values

Exclusion criteria:

* Hypersensitivity or intolerance to hypolipemics
* Significant myopathy or rhabdomiolysis probably caused by hypolipemics
* Uncontrolled endocrine or metabolic disease which is known to affect lipid or lipoprotein values (for example, hypothyroidism and hyperthyroidism)

Primary outcomes:
measure: Percentage of Participants Achieving Target Lipid Values
timeFrame: Baseline and Month 3
measure: Percentage of Participants With Reduced Cardiovascular Risk
timeFrame: Baseline and Month 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05312853: Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.
Official title: Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Liver Disease
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: Nordic Bioscience A/S
First posted: 2022-04-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be patients (aged ≥18 years) with risk factors for chronic liver disease recruited at the I. Department of Medicine of the University Medical Center Mainz in Germany.

Brief summary: Primary objective is to study the relevance of non-invasive test (NITs) in predicting disease stage (diagnostic biomarker) and outcome (predictive biomarker) in patients with suspected or established liver disease and cirrhosis.

Detailed description: Non-invasive tests (NITs) may complement and even reduce the need for liver biopsy in the diagnosis and follow up care of patients with chronic liver disease (CLD). NITs either include serum biomarkers (direct or indirect) or ultrasound-based tests, including vibration controlled transient elastography (VCTE), or a combination of both incorporated into several surrogate scores.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Clinically suspected chronic liver disease based on any of:

   1. Patient with historical liver biopsy providing histological evidence of any liver disease or,
   2. Patient undergoing liver biopsy for suspected chronic liver disease with biochemical and/or radiological findings consistent with liver disease or,
   3. Patient with clinical and radiological evidence of cirrhosis (in absence of an alternative aetiology)
   4. Patients with metabolic risk factors predisposing to CLD

Exclusion Criteria:

1. Refusal or inability (lack of capacity) to give informed consent.
2. Age \< 18 years
3. Pregnancy
4. An active malignancy.
5. Life expectation of \< 5 years.
6. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.

Primary outcomes:
measure: Overall survival
timeFrame: 10 years
Secondary outcomes:
measure: Liver-related events
timeFrame: 10 years
Other outcomes:
measure: Impact of liver disease on Quality of Life and Symptom-burden
timeFrame: 5 years
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenber Univeristy
Study officials:
affiliation: Hepatology
name: Joern Schattenberg, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04608253: A Retrospective Analysis of the Diagnostic Performance of 11C-choline PET/CT in Primary Hyperparathyroidism
Official title: A Retrospective Analysis of the Diagnostic Performance of 11C-choline PET/CT for Detection of Hyperfunctioning Parathyroid Glands After Prior Negative or Discordant Imaging in Primary Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hyperparathyroidism
Primary Hyperparathyroidism Due to Adenoma
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 36
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: This is a retrospective single-center cohort study of patients with biochemically proven pHPT who underwent parathyroid surgery after localization by means of 11C-choline PET/CT and negative or discordant first-line imaging in a teaching and tertiary referral hospital in the Netherlands between 2015 and 2019.

Brief summary: The leading cause of primary hyperparathyroidism (pHPT) is a solitary adenoma (89%). The treatment of pHPT is generally surgical removal of the overactive parathyroid gland(s). Since a solitary adenoma is the predominant cause, parathyroid surgery is preferably performed through a minimally invasive parathyroidectomy (MIP) in which only the suspected adenoma causing the pHPT is resected in a focused manner. To facilitate the performance of a MIP, accurate preoperative imaging is pivotal. This study aimed to analyze the diagnostic performance of 11C-choline PET/CT after prior negative or discordant first-line imaging in patients with pHPT undergoing parathyroid surgery with an optimized imaging protocol.


Eligibility criteria: Inclusion Criteria:

Patients eligible for inclusion were ≥18 years old, diagnosed with biochemically confirmed pHPT, underwent a MIBI-SPECT/CT and/or cUS with negative or discordant results, and underwent a 11C-choline PET/CT followed by parathyroidectomy.

Exclusion Criteria:

Patients were excluded if they were known to have a germline mutation predisposing for familial hypocalciuric hypercalcemia (FHH).

Primary outcomes:
measure: Sensitivity of 11C-choline PET/CT
timeFrame: Until 6 months after parathyroid surgery
measure: Positive predictive value of 11C-choline PET/CT
timeFrame: Until 6 months after parathyroid surgery
measure: Accuracy of 11C-choline PET/CT
timeFrame: Until 6 months after parathyroid surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center Groningen
name: Adrienne Brouwers, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277653: Study of PIVKA-II and AFP Measurement in Surveillance Program for Early Detection of Hepatocellular Carcinoma
Official title: Prospective, Randomized Study of PIVKA-II and AFP Measurement Every 3 Months Compared to AFP Every 6 Months in Surveillance Program for Early Detection of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Severance Hospital
First posted: 2011-01-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Liver cirrhosis

Brief summary: There is no prospective study on the test intervals of alpha-fetoprotein (AFP) or on the role of prothrombin induced vitamin K absence or antagonist-II (PIVKA-II) in surveillance program for early detection of hepatocellular carcinoma(HCC). The goal of this study is to compare if the testing of AFP + PIVKA-II in intervals of 3 months is more effective in diagnosing early stages of HCC than the 6 month interval of AFP that is commonly used

Detailed description: There is no prospective study on the test intervals of alpha-fetoprotein (AFP) or on the role of prothrombin induced vitamin K absence or antagonist-II (PIVKA-II) in surveillance program for early detection of hepatocellular carcinoma(HCC). The goal of this study is to compare if the testing of AFP + PIVKA-II in intervals of 3 months is more effective in diagnosing early stages of HCC than the 6 month interval of AFP that is commonly used

Eligibility criteria: Inclusion Criteria:

* LC

Exclusion Criteria:

* previous HCC

Primary outcomes:
measure: the difference of curative treatments & survival rates
timeFrame: 4 years
Secondary outcomes:
measure: the difference of early detection rates of HCC between both groups
timeFrame: 4 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu
Study officials:
affiliation: OFF
name: Myoung HA LEE, MD
role: STUDY_DIRECTOR
References: