louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03197844: Study on Registration of Xinyuan Capsule
Official title: Study on Registration of Xinyuan Capsule
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
First posted: 2017-06-23
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim population for observation is who using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Brief summary: The purpose of this study is get to know what and how Xinyuan capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.

Detailed description: In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or adverse drug reactions is one of the main aims for this study. Safety surveillance on Chinese medicine containing Radix Polygoni Multiflori is an important problem that needs to be sorted out through large sample observational study. According to the relevant regulations of the CFDA, 3000 cases need to be registered at least. The aim population is who using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Eligibility criteria: Inclusion Criteria:

* Patients using Xinyuan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Is there any abnormality in liver function test index（ALT、AST、TBil、GGT）after using xinyuan capsule around four weeks later?
timeFrame: After using xinyuan capsule around four weeks later.
Secondary outcomes:
measure: Is there any abnormality in renal function test index（Bun、Cr） after using xinyuan capsule around four weeks later?
timeFrame: After using xinyuan capsule around four weeks later.
measure: Is there any abnormality in ECG after using xinyuan capsule around four weeks later?
timeFrame: After using xinyuan capsule around four weeks later.
measure: Is there any abnormality in basic life sign（body temperature, blood pressure and pulse）during using xinyuan capsule around four weeks？
timeFrame: During using xinyuan capsule around four weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yanming Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03508544: Lumbar Erector Spinae Plane Block and Quadratus Lumborum Block in Hip and Proximal Femur Surgeries
Official title: Evaluation of Postoperative Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block in Hip and Proximal Femur Surgery, Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Multimodal analgesia is used to control postoperative pain in hip surgery. Quadratus lumborum block is an effective regional anesthesia technique for hip and proximal femur surgery. The erector spinae plane block applied to the lumbar region was also reported to provide effective analgesia in these surgeons. In this study, we aimed to determine and compare the effects of quadratus lumborum block and lumbar erector spinae plane block on postoperative pain in hip and proximal femur surgeons.


Eligibility criteria: Inclusion Criteria:

- Hip joint and proxiaml femur surgery, ASA 1-2-3

Exclusion Criteria:

* Patient refusal
* Contraindications to regional anesthesia
* Known allergy to local anesthetics
* Bleeding diathesis
* Use of any anti-coagulants
* Inability to provide informed consent
* Severe kidney or liver disease
* Inability to operate PCA system
* Patient with psychiatric disorders

Primary outcomes:
measure: Pain
timeFrame: 24 hours
Secondary outcomes:
measure: analgesic consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Maltepe University faculty of medicine
Study officials:
affiliation: Maltepe University Faculity of Medicine
name: Serkan Tulgar, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
citation: He J, Zheng XQ, Luo CH, Huang ZX, He WY, Wang HB, Yang CX. [Effects and safety of quadratus lumborum block in analgesia after hip arthroplasty]. Zhonghua Yi Xue Za Zhi. 2018 Feb 27;98(8):565-569. doi: 10.3760/cma.j.issn.0376-2491.2018.08.002. Chinese.
citation: Ueshima H, Yoshiyama S, Otake H. RETRACTED: The ultrasound-guided continuous transmuscular quadratus lumborum block is an effective analgesia for total hip arthroplasty. J Clin Anesth. 2016 Jun;31:35. doi: 10.1016/j.jclinane.2015.12.033. Epub 2016 Mar 22.
Clinical trial NCT03704844: Evaluation of the Renal Congestion, Perfusion and Function Before and After Diuretic Treatment in the ICU
Official title: Evaluation of the Renal Congestion, Perfusion and Function Before and After Diuretic Treatment in the ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Congestion
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 120
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: ICU patients under treatment by furosemide

Brief summary: Renal congestion is a pathological state that can lead to acute kidney failure. Furosemide is known to lower renal congestion by its diuretic effect.

The aim of this trial is to study the reversibility of kidney congestion under diuretic therapy and assess through echodoppler parameters if it can improve renal perfusion and function in congestive ICU patients.

It could in fine lead to a better identification of patients that could benefit from diuretic therapy in the ICU.


Eligibility criteria: Inclusion Criteria:

* patient hospitalized in ICU
* under furosemide treatment

Exclusion Criteria:

* participation refusal
* uncontrolled shock (MAP\<65mmHg)
* abdominal compartment syndrome
* diuretic administration in the 6 hours prior to inclusion
* renal replacement therapy or stage 4-5 chronic kidney disease
* atrial fibrillation
* no monitoring of CVP / invasive arterial pressure

Primary outcomes:
measure: Effects of diuretics
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Dijon
country: France
facility: CHU de Dijon
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT02040792: A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase 2B, 28-Day, Randomized, Double-Blind Placebo-Controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Keywords: COPD
Chronic Obstructive Pulmonary Disease
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Theravance Biopharma
First posted: 2014-01-20
Enrollment: 355
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.


Eligibility criteria: Inclusion Criteria:

* Subject is a male or female subject 40 years of age or older
* Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
* Subject is capable of performing reproducible spirometry maneuvers
* Subject has post-bronchodilator FEV1/FVC ratio \<0.7
* Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
* Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
* Subject has a current or past smoking history of at least 10 pack-years.

Exclusion Criteria:

* Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
* Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
* Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
* Subject has been hospitalized for COPD or pneumonia within 12 weeks
* Subject requires long-term oxygen therapy (\>15 hours a day)

Primary outcomes:
measure: Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)
timeFrame: Baseline to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Upstate Pharmaceutical Research
state: South Carolina
Study officials:
affiliation: Theravance Biopharma
name: Medial Monitor
role: STUDY_DIRECTOR
References:
citation: Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.
citation: Pudi KK, Barnes CN, Moran EJ, Haumann B, Kerwin E. A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease. Respir Res. 2017 Nov 2;18(1):182. doi: 10.1186/s12931-017-0647-1.
Clinical trial NCT00370292: Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Official title: Pemetrexed Monochemotherapy in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer. A Pilot Study to Define the Best Dosing Schedule for a Planned Phase II Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-08-31
Enrollment: 19
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: Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.


Eligibility criteria: Inclusion Criteria

* Histologically or cytologically proven IIIB and IV NSCLC.
* No symptomatic uncontrolled brain metastasis
* Not suitable for platinum containing regimens if chemo-naive
* Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
* Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min)

Exclusion Criteria

* Prior radiation to greater than 25% of bone marrow
* Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal anti-inflammatory agents for a 5-day period.
* Presence of clinically relevant third-space fluid collections not controllable.
* Significant cardiac disease

Primary outcomes:
measure: Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
timeFrame: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)
measure: Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
timeFrame: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)
Secondary outcomes:
measure: Best Objective Tumor Response
timeFrame: baseline to measured response (every 14 days for 6 cycles)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02915692: Study to Compare CAUTI Rates Following ERASE CAUTI Tray Silver vs Silver Coated Foley Catheters
Official title: A Clinical Study to Compare the CAUTI Rates Following ERASE CAUTI Tray Silver Coated Foley Catheters Verse Silver Coated Foley Catheters
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Surgery
Keywords: Foley
CAUTI
ERASE CAUTI
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 753
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects requiring Foley catheters

Brief summary: The Foley catheter is one component in a catheter insertion procedure that could contribute to a catheter associated urinary tract infection (CAUTI). Improvements in the catheter insertion procedure using the ERASE CAUTI Tray system may help to lower these infection rates.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Received either silver coated Foley catheter or ERASE CAUTI silver coated catheter

Exclusion Criteria:

* UTI present upon current hospital admission
* Burn patients, transplant patients, or immune-compromised patients.

Primary outcomes:
measure: Urinary tract infection rates
timeFrame: 2 days on average or until hospital discharge
Secondary outcomes:
measure: Catheter use
timeFrame: 2 days on average or until hospital discharge
measure: Catheter Associated Urinary Track Infection Costs
timeFrame: Post Infection costs incurred from insertion of catheter to hospital discharge (<30 days)
Other outcomes:
Locations:
city: Milledgenville
country: United States
facility: Oconnee Regional Medical Center
state: Georgia
Study officials:
affiliation: Parish Medical Center
name: S T Symeonides, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00602992: Exploring the Role of 3T MRI in Gamma Knife Radiosurgery
Official title: Exploring the Role of 3T MRI in Gamma Knife Radiosurgery: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Metastases
Keywords: 3T MRI
Gamma Knife Radiosurgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have consented to Gamma Knife radiosurgery.

Brief summary: Gamma Knife radiosurgery is a non-invasive technique for the delivery of a single, high dose of radiation to an intra-cranial target. MRI has an established and central role in the treatment planning process and assessment of response to intracranial radiosurgery. Increasing the field strength of MRI from 1.5T to 3T promises to improve the signal, and in turn the quality of images. However, the technology also introduces new limitations, and the role and safety of 3T MRI in the management of patients receiving radiosurgery has not yet been reported. In this pilot study, we will explore the spatial integrity, and incremental image-guidance utility of 3T MRI in patients receiving radiosurgery. The preliminary data acquired in this study will be instrumental to the judicious design and conduct of subsequent definitive clinical trials. Up to fifty patients will be enrolled in this study.


Eligibility criteria: Inclusion Criteria:

* Patients planned to receive Gamma Knife radiosurgery will be eligible for enrollment on this study.

Exclusion Criteria:

* Age\<18
* Contra-indications to 3T MRI, such as implanted metal devices or shrapnel.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Cynthia Menard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04145492: Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients
Official title: The Impact of Vitamin K2 and Inactive Vitamin D Supplementation on Vascular Calcification in Pediatric Patients on Regular Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: End Stage Renal Disease
Keywords: Hemodialysis and Vitamin K2
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.

Detailed description: Vascular calcification occurs in more than half of chronic renal failure patients, which mainly appears in the large and medium size arteries \[3, 4\]. It seems that vas¬cular calcification is caused by dynamic imbal-ance of intravascular calcium and phosphorus. However, more and more studies pointed out that vascular calcification were related with local cell's function and biological characteris¬tics.

The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.

Eligibility criteria: Inclusion criteria:

* Patients aged 6-18 years
* Patients on hemodialysis since 3 months or longer
* Hemodialysis frequency 3 times or more weekly

Exclusion criteria:

* Patients with life expectancy \< 3 months
* Patients taking warfarin
* Patients with known intestinal malabsorption

Primary outcomes:
measure: Uncarboxylated MGP
timeFrame: 4 months
measure: Uncarboxylated osteocalcin
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Radwa Maher El Borolossy
Study officials:
References:
citation: El Borolossy R, El-Farsy MS. The impact of vitamin K2 and native vitamin D supplementation on vascular calcification in pediatric patients on regular hemodialysis. A randomized controlled trial. Eur J Clin Nutr. 2022 Jun;76(6):848-854. doi: 10.1038/s41430-021-01050-w. Epub 2021 Nov 29.
Clinical trial NCT01613092: Prevention of Arrhythmia Device Infection Trial (PADIT)
Official title: Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arrhythmia
Keywords: Arrhythmia
Device Procedure
High risk patients
Antibiotics
Infection
Cluster
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of the pilot study is to compare whether a centre-wide policy of incremental antibiotic therapy will reduce pacemaker infection compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. This pilot study will provide feasibility information for a larger cluster randomized crossover design (CRCD).

Detailed description: Multi-center, cluster crossover, unblinded, pilot study. Centers will be randomized to conventional vs. incremental antibiotic therapy for 2 months or until eligible 20 patients are treated, whichever comes first. At 2 months, centers will have a crossover period of 4 weeks where the alternate strategy is implemented, followed by the final 2-month/20 patient enrolment period. During each treatment period the randomized antibiotic strategy will be used on all center patients undergoing a device implant procedure. Prior to the planned surgery or at the first follow up visit, patients who meet the study eligibility criteria will be approached to obtain consent for data collection purposes. Follow up will be according to usual clinical care at the center.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* received one of the following procedures:

  1. a second or subsequent procedure on the arrhythmia device pocket: i. ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement. ii. pocket or lead revision iii. system upgrade (insertion or attempted insertion of leads)
  2. new cardiac resynchronization therapy device implant (pacemaker or ICD)

Exclusion Criteria:

* life expectancy \< 12 months in the opinion of the local investigator.
* allergy or unable to tolerate cefazolin or clindamycin or vancomycin.
* allergy or unable to tolerate intracavitary bacitracin identified per-operatively.
* pre-operative identification that the patient has infection.

Primary outcomes:
measure: Hospitalization attributed to device infection
timeFrame: within one year of device procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital, McMaster University
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: University of British Columbia
name: Dr. Andrew Krahn, M.D
role: PRINCIPAL_INVESTIGATOR
References: