louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01002313: Effect of Prednisone onTregs and TH17
Official title: Effect of Prednisone on Peripheral Blood T-cell Function (Tregs and Th17) in Patients With Chronic Rhinosinusitis (CRS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinosinusitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with seasonal allergies taking prednisone and normal controls form the community.

Brief summary: The primary objective of this study is to see whether systemic corticosteroids (such as Prednisone) have an effect on the peripheral blood Treg and Th17 function in patients with CRS. Patients are taking prednisone as part of their routine medical care.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CRS.
* A CT scan performed in the last year depicting the severity of the disease or nasal polyps on endoscopy.
* Symptomatic at the time of entry into the study as determined by scores ≥ 1.4 on the Rhinosinusitis disability index

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, diabetes, osteoporosis, cataracts, glaucoma, neurological, oncologic, liver disease or a contraindication to taking prednisone).
* Use of any other investigational agent in the last 30 days.
* Use of clinical drugs like antihistamines, leukotriene modifiers, intranasal steroids, systemic corticosteroids in the last 15 days or immunotherapy in the last year.
* Upper respiratory infection within 14 days of study start
* Smoking within the last 2 months.

Primary outcomes:
measure: Treg cell numbers
timeFrame: pre treatment vs post treatment
Secondary outcomes:
measure: Cytokine levels in cultured PBMCs
timeFrame: pre vs post treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Robert M Naclerio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watanabe S, Pinto JM, Bashir ME, De Tineo M, Suzaki H, Baroody FM, Naclerio RM, Sharma S. Effect of prednisone on nasal symptoms and peripheral blood T-cell function in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Aug;4(8):609-16. doi: 10.1002/alr.21336. Epub 2014 Apr 21.
Clinical trial NCT02749513: Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients
Official title: Feasibility of Itraconazole as a Targeted Therapy for Inhibition of Hedgehog Pathway Signaling in Patients With Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Esophageal Cancer
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
First posted: 2016-04-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to demonstrate that orally administered itraconazole, a commonly used antifungal medication, can inhibit Hedgehog pathway signaling in patients with esophageal cancer, including adenocarcinoma (EAC) and squamous cell carcinoma (ESCC).


Eligibility criteria: Inclusion Criteria:

• Clinical diagnosis of esophageal cancer, including gastroesophageal junction cancer

Exclusion Criteria:

* Patients unwilling or unable to provide informed consent
* Coagulopathy that precludes safe endoscopic/surgical procedure (platelet count \<100,000/mm3, INR\>1.5)
* Esophageal varices
* Comorbidity (e.g. pulmonary, cardiac, renal, or liver disease) that precludes safe participation in the study
* QTc\>450 ms
* LFT's\>3xULN
* Pregnancy
* Allergy to itraconazole
* History of symptomatic congestive heart failure

Primary outcomes:
measure: Inhibition of Hedgehog pathway signaling as measured by real-time PCR.
timeFrame: 2-3 weeks
Secondary outcomes:
measure: Inhibition of VEGFR2 pathway signaling as measured by Western blot
timeFrame: 2-3 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
affiliation: North Texas Veterans Healthcare System
name: David Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim DJ, Kim J, Spaunhurst K, Montoya J, Khodosh R, Chandra K, Fu T, Gilliam A, Molgo M, Beachy PA, Tang JY. Open-label, exploratory phase II trial of oral itraconazole for the treatment of basal cell carcinoma. J Clin Oncol. 2014 Mar 10;32(8):745-51. doi: 10.1200/JCO.2013.49.9525. Epub 2014 Feb 3.
citation: Antonarakis ES, Heath EI, Smith DC, Rathkopf D, Blackford AL, Danila DC, King S, Frost A, Ajiboye AS, Zhao M, Mendonca J, Kachhap SK, Rudek MA, Carducci MA. Repurposing itraconazole as a treatment for advanced prostate cancer: a noncomparative randomized phase II trial in men with metastatic castration-resistant prostate cancer. Oncologist. 2013;18(2):163-73. doi: 10.1634/theoncologist.2012-314. Epub 2013 Jan 22.
citation: Zhang W, Bhagwath AS, Ramzan Z, Williams TA, Subramaniyan I, Edpuganti V, Kallem RR, Dunbar KB, Ding P, Gong K, Geurkink SA, Beg MS, Kim J, Zhang Q, Habib AA, Choi SH, Lapsiwala R, Bhagwath G, Dowell JE, Melton SD, Jie C, Putnam WC, Pham TH, Wang DH. Itraconazole Exerts Its Antitumor Effect in Esophageal Cancer By Suppressing the HER2/AKT Signaling Pathway. Mol Cancer Ther. 2021 Oct;20(10):1904-1915. doi: 10.1158/1535-7163.MCT-20-0638. Epub 2021 Aug 10.
Clinical trial NCT06895213: Evaluation of Plasma Renin Concentrations in Cardiac Surgery
Official title: Evaluation of Plasma Renin Concentrations in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Surgery With Cardiopulmonary Bypass
Keywords: renin-angiotensin system
RAS
hypotension
perfusion
shock
blood pressure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult persons 18 years of age or greater (female and male).

Brief summary: The purpose of this research is to learn more about how renin (a blood test) is affected by cardiopulmonary bypass, the heart-lung machine used during open heart surgery. Renin is a protein that may be elevated in response to low blood pressure or situations where organs do not receive sufficient oxygen. Renin may potentially be used as an indicator for specific treatments aimed to increase the blood pressure. This study will evaluate blood samples for renin concentration throughout the course of open heart surgery.

Detailed description: The investigator hypothesizes that renin concentrations will increase with exposure to cardiopulmonary bypass and that increased renin concentrations will be associated with the development of vasoplegia.

Specific Aim 1. To characterize the effects of cardiopulmonary bypass on plasma renin concentrations in adults undergoing cardiac surgery.

Specific Aim 2. To test the prognostic value of plasma renin concentrations on outcomes following cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Adult persons 18 years of age or greater.
* Scheduled for an elective cardiac surgical procedure involving the use of cardiopulmonary bypass.

Exclusion Criteria:

* Surgery involving heart or lung transplantation or implant of a durable left ventricular assist device.
* Emergency cardiac surgery.
* Established diagnosis of any congenital heart disease.
* End-stage kidney disease receiving kidney replacement therapy before surgery.

Primary outcomes:
measure: Plasma renin concentrations
timeFrame: Up to 24 hours after surgery
Secondary outcomes:
measure: Vasoplegia
timeFrame: First 24 hours postoperative
measure: Acute kidney injury
timeFrame: 7 days
measure: Organ dysfunction
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Patrick M Wieruszewski, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03611413: Feasibility and Effects of an Enhanced Recovery vs Conventional Care After Emergency Colon Surgery for Patients With Left Colon Perforation.
Official title: Feasibility and Effects of an Enhanced Recovery vs Conventional Care After Emergency Colon Surgery for Patients With Left Colon Perforation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Perforation
Keywords: COLON PERFORATION SURGERY
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: emergency surgery with a diagnosis of left colon perforation

Brief summary: A study was designed with a prospective cohort of all patients undergoing urgent surgery for left colon perforation between March 2014 and June 2017 who were treated according to a specific ERAS programme (ERAS group/29 patients). This group was compared with a historic case-matched control group with conventional care (CC group/21 patients). The main endpoints were postoperative 30-day morbidity, length of postoperative hospital stay, rate of readmission within 30 days, and mortality. The inclusion criteria were patients over 18 years old with a low-moderate risk of mortality according to a Peritonitis Severity Score (PSS) between 6-11 points.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were patients over 18 years old with a low-moderate risk of mortality according to a Peritonitis Severity Score (PSS), between 6-11 points.

Exclusion Criteria:

* The exclusion criteria were patients under 18 years old and patients with a high risk of mortality according to a PSS equal to or greater than 12 points.

Primary outcomes:
measure: number of items completed of ERAS protocol
timeFrame: 1-month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01244113: Optimal Dose of Propofol for Induction of Deep Sedation for Brain MRI Scanning in Children With Cerebral Palsy
Official title: Optimal Dose of Propofol for Induction of Deep Sedation for Brain MRI Scanning in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The children with CP has been shown different drug responses from the normal population of children and it may related with a various oral medications such as baclofen, tizanidine, diazepam, dantrolene, or anticonvulsant drugs.

The aim of this study is to establish the optimal induction dose of propofol for deep sedation to start MRI for \< 30 min in children with CP.


Eligibility criteria: Inclusion Criteria:

* children with cerebral palsy with patient agreement

Exclusion Criteria:

* sleep apnea, difficult airway, cardiorespiratory disease, allergic history to propofol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Hae-Keum Kil, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05384236: A Comparative Study of Kinesiology Taping Versus Taping in the Treatment of Plantar Fasciitis
Official title: A Comparative Study of Kinesiology Taping Versus Taping in the Treatment of Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Plantar fasciitis is a very studied pathology and treated with taping. There are studies that assess the effectiveness of Kinesio taping, as well as taping or low-dye taping, few studies that compare the two treatments and assess which is more effective.

In the present work the effectiveness of Kinesio taping and taping will be assessed, as well as whether possible differences among intervention effects exist in terms of pain improvement, comfort and durability of the bandage.


Eligibility criteria: Inclusion Criteria:

* People with plantar fasciitis.
* People of legal age.

Exclusion Criteria:

* Healthy people
* Minors.
* People with pathologies other than plantar fasciitis in the foot.
* People who have treatment for fasciitis at the time of starting the study

Primary outcomes:
measure: Visual Analogue Scale of Pain
timeFrame: seven days
measure: comfort
timeFrame: seven days
measure: Visual Analogue Scale of Mobility
timeFrame: seven days
measure: Visual Analogue Scale of comfort
timeFrame: seven days
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universitat de València
Study officials:
References:
Clinical trial NCT03213236: OSA Homemonitoring
Official title: OSA Homemonitoring
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Up to now, no studies are available where a comparison has been made between the accuracy of, on the one hand, the gold standard PSG and, on the other hand, a home monitoring sleep apnea-diagnostic system, consisting of a pulse oximeter, and accelerometer, a smartphone for snoring analysis, and a mattress for ballistocardiographic (BCG) recordings.

The purpose of this study is twofold. On the one hand, a comparison between the predictive performance of an automated home monitoring system and the gold standard PSG in sleep apnea diagnosis will be performed. The home monitoring system consists of a pulse oximeter, an accelerometer, a smartphone to record ambient sound, and a mattress to record the BCG signal. This system will be provided by KU Leuven and Equilli, two partners that work together with the Sleep Laboratory at UZ Leuven and the group STADIUS of the KU Leuven in the OSA+ project. The system performs automated signal processing and classification in order to determine the presence of sleep apnea events. On the other hand, this study aims to improve the phenotyping of patients suffering from sleep apnea. This task will be first developed using the classical PSG and later an evaluation will be performed on the less obtrusive system.


Eligibility criteria: Inclusion Criteria:

* Patients referred to the sleep lab for a diagnostic polysomnography because of suspicion of sleep apnea will be considered to participate in the trial upon signature of the informed consent.

Exclusion Criteria:

* Patients younger than 18 years

Primary outcomes:
measure: Diagnostic accuracy of the homemonitoring system
timeFrame: 1 day
Secondary outcomes:
measure: Cardiovascular risk prediction tool
timeFrame: 1 day
measure: Apnea/hypopnea index severity
timeFrame: 1 day
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: UZ Leuven
name: Bertien Buyse, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00588536: Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH
Official title: Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With Langerhans Cell in Histiocytosis (LCH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Langerhans Cell Histiocytosis
Keywords: Langerhans Cell Histiocytosis
LCH
6-Thioguanine
6-TG
Methotrexate
MTX
94-132
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX).


Eligibility criteria: Inclusion Criteria:

* Patients with histologic proof of LCH who have multifocal or multisystem disease involvement.
* Patients must have a life expectancy of at least 8 weeks.
* All patients must have ECOG performance level rating of-\< 2.
* Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study, using commercially available drugs.
* Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of chemotherapy.
* Patients must have adequate liver function (bilirubin _\< 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine \<_ 1.5 mg/dl, creatinine clearance \>_ 60 ml/min/1.73 m2) and normal electrolytes.
* Patients should have a granulocyte count \> 500/uL and a platelet count \>_ 100,000/uL (unless due to disease involvement of the bone marrow).
* Male and female patients of child-bearing age should use effective methods of contraception, if sexually active.

Exclusion Criteria:

* Patients with active infections or significant medical conditions other than their disease (LCH) shall be excluded.

Primary outcomes:
measure: Determine the Incidence of Complete and Partial Response and the Duration of Response in Patients With Langerhans Cell Histiocytosis (LCH) Treated With Sequential Administration of Oral 6-TG After MTX.
timeFrame: Conclusion of the study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Tanya Trippett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03690336: Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
Official title: Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Haemophilia B
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-10-01
Enrollment: 10
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 with haemophilia B

Brief summary: The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol. The third party registries include PedNet Haemophilia Registry (PedNet) and the European Haemophilia Safety Surveillance System (EUHASS). Data from national and international registries in countries where nonacog beta pegol has been approved and marketed could be included in the data collection.


Eligibility criteria: Inclusion Criteria:

- Participation in the PedNet Registry and/or the European Haemophilia Safety Surveillance System (EUHASS), or other national and international registries

Exclusion Criteria:

- Not applicable as this is a study collecting third-party data from registries

Primary outcomes:
measure: Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B
timeFrame: From start of data collection (week 0) to end of data collection (after 9 years)
Secondary outcomes:
measure: Other ADRs reported to the registries during the study period with suspected relation to nonacog beta pegol in patients with haemophilia B
timeFrame: From start of data collection (week 0) to end of data collection (after 9 years)
Other outcomes:
Locations:
city: Baarn
country: Netherlands
facility: PedNet Haemophilia Registry
city: Sheffield
country: United Kingdom
facility: European Haemophilia Safety Surveillance Registry
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (2834)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01710436: Relationship Between Dosage of Clopidogrel and Platelet Aggregation in Chinese With Different Genotype
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2012-10-19
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese coronary heart disease (CHD) patient

Brief summary: This study is a prospective, observational study to estimate the relationship between dosage of clopidogrel and platelet aggregation in Chinese with different genotype. The investigators suppose both pretreatment dosage of clopidogrel before percutaneous coronary intervention (PCI) and CYP2C19 genotype may effect the platelet aggregation as well as clinical outcome.


Eligibility criteria: Inclusion Criteria:

* accept PCI in Chinese CHD patients
* expected dual antiplatelet therapy (DAPT) at least 6 months

Exclusion Criteria:

* another planned PCI within 6 months

Primary outcomes:
measure: Change from Baseline in platelet aggregation
timeFrame: 1 month and 6 months after PCI
Secondary outcomes:
measure: Major adverse cardiovascular events (MACE); Bleeding events
timeFrame: 6 months after PCI
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute and Fu Wai Hospital, CAMS & PUMC
Study officials:
References:
citation: Zhang X, Yan L, Wang D, Li Y, Han L, Tian L, Liu H, Li Y. Comparison of loading with maintenance dose of clopidogrel on platelet reactivity in Chinese with different CYP2C19 genotypes prior to percutaneous coronary intervention. Chin Med J (Engl). 2014;127(14):2571-7.