louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00087984: RNA-Loaded Dendritic Cell Cancer Vaccine
Official title: A Phase I/II Study To Examine The Safety, Feasibility, Immunological Response, And Measures Of Clinical Antitumor Activity After Administering Unselected, Autologous, Amplified Tumor Total RNA-Transfected, Dendritic Cell Vaccine (MB-002) To Patients With Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Renal Cell Carcinoma
Keywords: Kidney cancer
Renal cancer
Lead sponsor: Argos Therapeutics
Sponsor class: INDUSTRY
First posted: 2004-07-20
Enrollment: 26
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: The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Have a new diagnosis of metastatic renal cell carcinoma;
* Must be at least 18 years or older;
* Have a scheduled unilateral nephrectomy;
* ECOG of 0 or 1;
* Free of brain metastases by CT or MRI;
* Normal renal function in contralateral kidney;
* Male or non-pregnant/non-lactating female on appropriate birth control methods while on study;
* Clinically acceptable screening results.
* No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry;
* No active autoimmune disease

Primary outcomes:
measure: To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.
timeFrame: From registration until disease progression or withdrawal from study
measure: To measure clinical antitumor activity including objective tumor response and an estimate of time to tumor progression (or progression-free interval).
timeFrame: From registration until disease progression or withdrawal from study
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California - Irvine
state: California
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT06909084: Hearing Improvement After Making a Hole Surgically in Eardrum With or Without Ventilation Tube in Children With Glue Ears
Official title: Comparison of Outcome of Myringotomy With or Without Ventilation Tube in Children With Glue Ears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media With Effusion in Children
Hearing Loss
Keywords: Otitis Media with Effusion
Hearing Loss
Children
Middle ear Ventilation
Lead sponsor: Allama Iqbal Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effectiveness of myringotomy with ventilation tube insertion to myringotomy alone in improving hearing in children with glue ear.

The main question it aims to answer is:

Does adding a ventilation tube to myringotomy lead to greater improvement in hearing compared to myringotomy alone? Researchers will compare these two surgical techniques to determine which offers better outcomes for children with otitis media with effusion.

The Participants will:

1. Have their hearing evaluated before surgery
2. Undergo either myringotomy with ventilation tube insertion or myringotomy alone
3. Have their hearing evaluated at follow-up visits at 2 weeks, 1 month, and 3 months post-operatively


Eligibility criteria: Inclusion Criteria:

* cases of otitis media with effusion
* more than 20 decibel (dB) conductive hearing loss on pure tone audiometry
* non-responder to medical treatment after three months of medical treatment

Exclusion Criteria:

* Children having recurrent otitis media
* Discharging ears
* History of bleeding disorder

Primary outcomes:
measure: Improvement in hearing
timeFrame: Before and Three months post operatively
Secondary outcomes:
measure: Hearing Loss (dB)
timeFrame: Before and Three months post operatively
measure: Degree of Hearing Loss
timeFrame: Before and Three months post operatively
Other outcomes:
Locations:
city: Dera Ghazi Khan
country: Pakistan
facility: Allama Iqbal Teaching Hospital Dera Ghazi Khan
state: Punjab
Study officials:
affiliation: Allama Iqbal Teaching Hospital Dera Ghazi Khan
name: Dr. Sharbaz Hussain Khosa, FCPS
role: STUDY_CHAIR
References:
Clinical trial NCT04199884: Online Psychoeducation for Intolerance of Uncertainty
Official title: Online Psychoeducation for Intolerance of Uncertainty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intolerance of Uncertainty
Anxiety
Keywords: Intolerance of Uncertainty
Anxiety
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Mary Oglesby Shapiro
First posted: 2019-12-16
Enrollment: 84
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: PREVENTION

Brief summary: Randomized control trial examining the efficacy of an online intolerance of uncertainty focused psychoeducation intervention.

Detailed description: Randomized control trial examining the efficacy of an online intolerance of uncertainty (IU) focused psychoeducation intervention among females elevated in IU.

Eligibility criteria: Inclusion Criteria:

* Elevated intolerance of uncertainty at baseline

Exclusion Criteria:

* Patients would be excluded if they endorsed suicidal ideation/intent that required hospitalization.

Primary outcomes:
measure: Intolerance of Uncertainty (IIU)
timeFrame: Baseline to one-month follow-up
measure: Beck Anxiety Inventory
timeFrame: Baseline to one-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Anxiety and Behavioral Health Clinic
state: Florida
Study officials:
References:
Clinical trial NCT02092584: Effect of Omega-3 Supplementation on Serum Level and Gene Expression of IGF-1and IGFBP-3 in Men With CVD.
Official title: Effect of Omega-3 Supplementation on Serum Level and Gene Expression of IGF-1and IGFBP-3 in Men With Cardiovascular Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
Keywords: atherosclerotic
IGF-1
IGFBP-3
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 31
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of IGF-1 and IGFBP-3 and gene expression of IGF-1 in patients with cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* CVD patients 45- 65 years old, patients with ≥ 50% stenosis in at least one coronary angiogram demonstrated, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willingness to participation,

Exclusion Criteria:

* people who have used omega 3 supplements in last 3 months, having chronic renal disease , GI disease, hepatobiliary diseases, hematological disorders, hypo- or hyperthyroidism, Smokers

Primary outcomes:
measure: Serum Total Cholesterol
timeFrame: Change from baseline at 2 months
measure: Serum HDL-C
timeFrame: Change frome baseline at 2 months
measure: Serum LDL-C
timeFrame: Change frome baseline at 2 months
measure: Serum TG
timeFrame: Change frome baseline at 2 months
measure: Serum Fasting Blood Sugar(FBS)
timeFrame: Change frome baseline at 2 months
measure: Serum Insulin
timeFrame: Change frome baseline at 2 months
measure: Serum hsCRP
timeFrame: Change frome baseline at 2 months
measure: Serum Insulin Like Growth Factor-1(IGF-1)
timeFrame: Change frome baseline at 2 months
measure: Serum IGF binding protein 3(IGFBP-3)
timeFrame: Change frome baseline at 2 months
Secondary outcomes:
measure: Gene Expression of IGF-1
timeFrame: Change frome baseline at 2 months
measure: Gene expression of IGFBP3
timeFrame: change from baseline at 2 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
References:
Clinical trial NCT03969784: Microparticles in Peritoneal Carcinomatosis of Colorectal Origin
Official title: Microparticles in Peritoneal Carcinomatosis of Colorectal Origin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Peritoneal carcinomatosis (PC), a tumoral tumor of the peritoneum, is a frequent metastatic localization of colorectal cancer (CRC, 13%). Long regarded as a palliative situation, its management has progressed significantly with a curative treatment based on a complete cytoreduction surgery coupled with intraperitoneal hyperthermic chemotherapy. However current screening tools, tumor markers (ACE, CA19-9, CA125) and abdominopelvic CT scan are insufficient, to diagnose CP early. A non-invasive biomarker, more sensitive and more specific than currently available tumor markers, would be a major advance in oncology. Microparticles (MPs), vesicles from extracellular membrane budding in response to cell activation or apoptosis of different cell types, have been described as implicated in tumor progression, procoagulant activity associated with cancer, and initiation of metastatic niches. A specific microparticulate (microparticulosome) signature has been reported in patients with CRC, particularly in the presence of a thromboembolic event. However, there is currently no data on PMs and their involvement in CP. In addition, CP and surgery coupled with hyperthermic intraperitoneal chemotherapy are major risk factors for thromboembolic complications. The characterization of prothrombotic PMs is therefore essential to predict such event.

The main objective of this project is to characterize the microparticulate signature of CP of colorectal origin and to compare it with that of CP without CP. The secondary objectives are to compare the microparticulate signature obtained on peripheral venous samples and intraoperative tumor samples, evaluate the evolution of the microparticulate signature between the beginning and the end of the intervention, then correlate the peripheral signature to the oncological follow-up of the patients with CP and the occurrence of a thromboembolic event.


Eligibility criteria: Inclusion Criteria:

* patient presenting a peritoneal carcinomatosis from colorectal cancer origin

Exclusion Criteria:

* patient presenting a peritoneal carcinomatosis from other pathologies than colorectal cancer origin

Primary outcomes:
measure: percentage of microparticule
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assitance Publique Hopitaux de Marseille
name: Emilie Garrido
role: STUDY_DIRECTOR
References:
Clinical trial NCT01130584: Pyruvate Kinase Isoform M2 (PKM2) as a Possible Biomarker for Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer Patients
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2010-05-26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any cancer patient

Brief summary: The purpose of this study is to determine if pyruvate kinase M2 (PKM2) can be used as a biomarker in cancer.

Pyruvate kinase M2 is more elevated in malignant pleural fluid than in plasma, and may be a useful biomarker to distinguish between malignant and non-malignant causes of pleural effusion. In addition, pyruvate kinase M2 has also been found to be elevated in saliva in cancer patients compared to controls. Measuring pyruvate kinase M2 in saliva may be used to diagnose cancer or monitor the treatment progress of cancer.


Eligibility criteria: Inclusion Criteria:

* Any cancer patient with pleural effusion that is being drained through an indwelling chest-tube in an inpatient ward.

Exclusion Criteria:

* Patient with a pleural effusion who does not have proven cancer or whose pleural effusion is not known to be malignant.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
Study officials:
References:
citation: Elia S, Massoud R, Guggino G, Cristino B, Cortese C, De Massimi AR, Zenobi R. Tumor type M2-pyruvate-kinase levels in pleural fluid versus plasma in cancer patients: a further tool to define the need for invasive procedures. Eur J Cardiothorac Surg. 2008 Apr;33(4):723-7. doi: 10.1016/j.ejcts.2008.01.014. Epub 2008 Feb 7.
citation: Mazurek S. Pyruvate kinase type M2: a key regulator within the tumour metabolome and a tool for metabolic profiling of tumours. Ernst Schering Found Symp Proc. 2007;(4):99-124. doi: 10.1007/2789_2008_091.
Clinical trial NCT04947384: Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures
Official title: Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing mitral valve procedures at the University of Alabama at Birmingham main hospital

Brief summary: The objective of this proposal is to study circulating and echocardiographic markers of pulmonary vascular and right ventricular remodeling in patients with a WHO-2 diagnosis of pulmonary hypertension after mitral valve procedures. The investigators are proposing the study will be impactful for the early detection and prediction and of residual pulmonary hypertension (PH) that would otherwise be undetected and fatal with no curative treatment.

Detailed description: The investigators will enroll 3 groups: Group 1: Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures. Group 2: Patients with no PH undergoing open and interventional mitral valve procedures. Group 3: Patients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. Groups 2 and 3 will serve as controls. All procedures will be performed at the main UAB Hospital cardiac surgical operating rooms and at the cardiac angiographic suites. The investigators will collect a total of 3 blood samples; the first sample will be obtained on arterial cannulation before the initiation of the intervention, the second sample will be collected upon the end of the procedure prior to leaving the procedure room, and the third sample will be collected on the day of discharge from the hospital. A comprehensive echocardiogram at the 3 corresponding time points of the blood samples obtained; before, and after the intervention and before discharge.

Eligibility criteria: Inclusion Criteria:

* \>= 18 years/old

Exclusion Criteria:

* Patients with ejection fraction (EF) \< 35%
* Patients with severe tricuspid valve regurgitation
* Transplant patients
* Patients scheduled for ventricular assist devices
* Patients with a diagnosis of heart failure with preserved ejection fraction
* Any aortic valvular disease

Primary outcomes:
measure: Biomarker analysis
timeFrame: From baseline through one year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Ahmed Zaky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05707884: Volatiles in Critical Care After Free Flap Surgery
Official title: Prospective Evaluation of Volatile Sedation Management in Critical Care After Free Flap Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation Set-up Time
Additional Time Required for Volatile Sedation
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients undergoing complex free flap surgery are randomised to volatile or intravenous sedation in terms of subsequent intensive care sedation, based on the in-hospital standard of care. For study purposes, differences in management (set-up times, change of filters, etc.) will be investigated in relation to accelerated awakening and possibly improved neurocognition after the end of sedation.


Eligibility criteria: Inclusion Criteria:

* Free flap surgery
* Patient capable of giving informed written consent

Exclusion Criteria:

* Intolerance to volatile anaesthetics (e.g. malignant hyperthermia).
* Severe obstructive pulmonary disease
* Pre-existing severe neurocognitive disorder
* Age \<18 years (minors)

Primary outcomes:
measure: Material consumption
timeFrame: Inventory of the required materials until the end of sedation (90 hours)
measure: Working time expenditure
timeFrame: Inventory of the required time until the end of sedation (90 hours)
Secondary outcomes:
measure: Delir
timeFrame: Within the intensive care stay (5 days)
measure: Time to awake
timeFrame: Within the intensive care stay (5 days)
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
References:
Clinical trial NCT03300284: Decision Making and Psychological Outcomes in Low-Risk Papillary Thyroid Cancer
Official title: Decision Making and Psychological Outcomes in Low-Risk Papillary Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Keywords: Quality of Life
Decision Making
17-382
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted primarily in the MSK endocrinology and surgery clinics, which have a large volume of patients with LR-PTC choosing both surgery and AS. We also expect to expand this study to several clinics within the MSK Alliance Network and outside participating sites.

Brief summary: This study is being done to understand the decision-making process regarding management choice in low-risk papillary thyroid cancer.


Eligibility criteria: Inclusion Criteria:

* Able to read, write, and communicate in English Patients who have been diagnosed with LR-PTC as described above
* For Aim 1, adults with recently diagnosed LR-PTC who have not yet made a choice between surgery and AS
* For Aim 2, adults with LR-PTC who made a decision about surgery or AS at least 3 months prior, but no more than 4 years prior to their routine follow-up visit at which they are being recruited for this study.
* Active patients of MSK and participating institutions

Exclusion Criteria:

* Patients who have been diagnosed with a tumor greater than 2 cm
* Patients with clinically suspicious lymphadenopathy in the neck
* Patients with evidence of gross ETE after a biopsy of the papillary thyroid tumor

Primary outcomes:
measure: influencing decision making pre-visit
timeFrame: 3 years
measure: influencing decision making post-visit
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare (Data Collection)
state: Connecticut
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and Follow up)
state: New Jersey
city: Brooklyn
country: United States
facility: MAIMONIDES MEDICAL CENTER (Data collection only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Benjamin Roman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01159184: Stressors, Coping Methods and Social Support in Diabetic Patients
Official title: Stressors, Coping Methods and Social Support in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: stress
coping methods
social support
diabetes mellitus
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 301
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Type 2 diabetes
2. Aged 30-80 year old
3. under oral hypoglycemic agents
4. clear consciousness

Brief summary: The increasing prevalence of diabetes brought great burden to health status of the investigators population. It is meaningful to investigate the stressor, stress perceived, social support and coping methods in diabetic population in order to provide appropriate assistance to these patients. This study will recruit diabetes patients from out-patient-department and they are invited to complete a questionnaire. The contents of the questionnaire including stress experienced, stress perceived, social support and coping methods. The investigators purpose is to find out the impact of these factors on glycemic controlled and their life quality. The results will be useful to diabetes care team when health education is delivered to patient.

Detailed description: Type 2 diabetes patient aged 30-80 y/o under oral hypoglycemic agents with clear conscious enable to answer questions properly who regularly follow up at our metabolism clinic is eligible. Patients are asked to complete a questions containing basic personal information, diabetes coping method Chinese version (DCM-C)questionnaire, social support and perceived stress scale.

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes
2. Aged 30-80 year old
3. under oral hypoglycemic agents
4. clear consciousness

Exclusion Criteria:

1. Type 1 diabetes
2. Age below 30 and above 80
3. Insulin use
4. Conscious not clear

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Banciao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Taipei county
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Ju Ying Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: