louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01139086: Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure (CHF)
Official title: Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Heart Failure
Coronary Disease
Dilated Cardiomyopathy
Keywords: chronic heart failure
isokinetic test
near-infrared spectroscopy
laser Doppler flowmetry
endothelial function
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Heart Failure Coronary Disease Dilated Cardiomyopathy Control group without diagnosis of any heart disease

Brief summary: Shortness of breath, fatigue, and exercise intolerance are clinical symptoms of chronic heart failure (CHF). Recent studies suggested that peripheral impairment was the major cause of clinical symptoms, and mechanism may be related to neuroendocrine impairment and vascular smooth muscle dysfunction. It results in increased peripheral resistance that may influence limb blood flow, muscle fitness and activities of daily.The purposes of this study are

1. to compare muscular strength, endurance, and perfusion of quadriceps between CHF patients and healthy controls by isokinetic test and near-infrared spectroscopy (NIRS) and difference in activities of daily living
2. to compare endothelium function between CHF patients and healthy control subjects
3. the relationship between endothelium function, muscular strength, endurance, perfusion, and metabolism of quadriceps.


Eligibility criteria: Inclusion Criteria:

* Age 40-75 years
* Chronic heart failure: ejection fraction\<40% and at stable condition
* Coronary Disease and dilated cardiomyopathy without heart failure
* Control group without diagnosis of any heart disease

Exclusion Criteria:

* Clinical diagnosis of neuromusculoskeletal , pulmonary, or other systemic diseases that may affect the testing of the study

Primary outcomes:
measure: muscle strength and endurance
timeFrame: baseline
Secondary outcomes:
measure: skeletal muscle oxygenation response
timeFrame: baseline
measure: Walking distance in 6-minute walking test
timeFrame: baseline
measure: laser Doppler flowmetry combine iontophoresis
timeFrame: baseline
measure: sit-to-stand test
timeFrame: baseline
measure: questionnaire (functional activity and quality of life)
timeFrame: baseline
measure: Analysis of venous blood sample
timeFrame: baseline
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ying-Tai Wu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942786: Natriuretic Peptides - Predictors of In-hospital and Long-term Major Adverse Cardiac Events After Emergency Surgery?
Official title: Prospective Study to Evaluate the Predictive Value of Brain Natriuretic Peptides for Adverse Long-term Cardiac Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: natriuretic peptides
emergency non-cardiac surgery
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2009-07-21
Enrollment: 297
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing emergency non-cardiac surgery

Brief summary: The investigators hypothesize that the level of perioperative natriuretic peptides is associated with in-hospital and long term major adverse cardiac events.

Detailed description: The purpose of the study is to measure levels of brain natriuretic peptides before and after urgent non-cardiac surgery and to evaluate their predictive value for adverse long-term outcome.

Eligibility criteria: Inclusion criteria:

* Emergency surgery:

  1. Vascular
  2. Intra-abdominal
  3. Orthopedic

     Exclusion Criteria:
* Patients unable to provide informed consent
* Thoracic surgery
* Trauma surgery

Primary outcomes:
measure: Occurence of Adverse Cardiac Events
timeFrame: postoperatively (index surgery) until a median follow-up of 34 months
Secondary outcomes:
Other outcomes:
measure: NT-ProBNP Preoperative
timeFrame: 0-24 hours before induction of anesthesia
measure: Association Between Preoperative NT-ProBNP and Occurence of Adverse Cardiac Events
timeFrame: postoperatively (index surgery) until a median follow-up of 34 months
Locations:
city: Graz
country: Austria
facility: Department of Anesthesia and Intensive Care Medicine
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz
name: Elisabeth Mahla, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03209986: Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis
Official title: Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Liver Cirrhosis
Mesenchymal Sem Cells
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.

This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment）or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-65 years
2. HBV -related liver cirrhosis
3. Child-Pugh score ≥7
4. With presentations of decompensation
5. Written consent

Exclusion Criteria:

1. Hepatocellular carcinoma or other malignancies
2. Severe problems in other vital organs(e.g.the heart,renal or lungs)
3. Pregnant or lactating women
4. Severe bacteria infection
5. Anticipated with difficulty of follow-up observation
6. Coinfection with HIV or other viral hepatitis.
7. Drug abuse or alcohol abuse
8. History of severe allergy to biological products
9. Other candidates who are judged to be not applicable to this study by doctors -

Primary outcomes:
measure: Efficacy: Change of liver functions as assessed by MELD score
timeFrame: 1 year
measure: Safety: Adverse events as assessed according to CTCAE 4.03
timeFrame: 1 year
Secondary outcomes:
measure: Survival Benefit: Survival Rate at different time points
timeFrame: 1 year, 2 year and 5 years
measure: Histological change of the liver: Histological scores assessed by liver biopsy
timeFrame: 1 year, 2 year and 5 years
measure: Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy
timeFrame: 1, 2 and 5 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Disease, Xijing Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT02996786: Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners
Official title: Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Anemia
Inflammation
Oxidative Stress
Iron Deficiency
Hemolysis
Fatigue
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 39
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood biochemical parameters in male recreational runners.

Detailed description: 1. Male recreational runners would be recruited by community websites or email. After completely introducing the study, the participants would be requested to sign informed consent.
2. The participants would perform maximal oxygen consumption test prior to the supplementation. The participants would be supplemented with either Danggui Buxue Tang or placebo for a week before performing the 13-km run. A total of 4 times blood collection (before supplementation, immediate after running, 1 day and 3 days after running) would be performed for evaluating the effect of Danggui Buxue Tang on blood biochemical parameters.

Eligibility criteria: Inclusion Criteria:

* The participants should have the experience finishing 10-km run but without the experience of attending a marathon run.

Exclusion Criteria:

* Participants suffering from anemia (Hb \<13 g/dL), taking usual supplements, medication, alcohol or not feeling comfortable.

Primary outcomes:
measure: Hematological parameters
timeFrame: Through study completion, an average of 1 year
measure: Iron status
timeFrame: Through study completion, an average of 1 year
measure: Oxidative stress
timeFrame: Through study completion, an average of 1 year
measure: Inflammatory response
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Running time
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
References:
Clinical trial NCT03857386: Efficacy of Pectoral Nerve Block for Breast Reduction Surgery
Official title: Comparison of The Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Analgesia for Breast Reduction Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nerve Blocks
Breast Surgery
Postoperative Pain
Keywords: pectoral nerve block (PECS block)
breast reduction surgery
ultrasonography
postoperative pain
VAS score
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-02-28
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included patients with ASA I-II, 18-65 years old, with a BMI ≤ 40 kg/m2 and undergoing elective breast reduction operation under general anesthesia.

Brief summary: The purpose of the study is to evaluate the efficacy of PECS block applied to patients undergoing bilateral breast reduction surgery on postoperative analgesia compared to local infiltration anesthesia.

Detailed description: Pectoral nerve block (PECS block) has been developed as an alternative to thoracic paravertebral and/or thoracic epidural blocks in recent years. It is frequently applied for postoperative analgesia especially in breast cancer surgery and subpectoral breast prosthesis.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology (ASA) I-II
* body mass index (BMI) ≤40 kg/m2
* elective bilateral breast reduction surgery

Exclusion Criteria:

* declining to give written informed consent
* ASA III and above
* under 18 years of age or over 65 years of age
* history of allergy against to the local anesthetics,
* controendication of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc.)
* history of breast surgery
* treatment due to psychiatric disorder
* history of treatment for a chronic pain
* history of nerve blocks in order to treat postoperative pain

Primary outcomes:
measure: postoperative visual analog scale (VAS) score
timeFrame: postoperative 0, 1, 3, 6, 9, and 12 hours
Secondary outcomes:
measure: analgesia consumption
timeFrame: 12 hours
measure: length of hospital
timeFrame: 4 days
measure: analgesia consumption
timeFrame: during the surgery
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Netherlands: Ministry of Health, Welfare and Sports
name: Arzu Karaveli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
Clinical trial NCT03406286: Samsca PMS in ADPKD Patients
Official title: Post-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Safety
Keywords: Post Marketing Surveillance
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 600 patients will be enrolled for survey period (10 years). Especially, Liver injury cases of all patients in actual use of Samsca® Tablets to slow the progression of cyst development and renal insufficiency will be focused on monitoring.

Brief summary: This is a Post-Marketing Surveillance study(PMS) of Samsca® tablets in actual use in cases to slow the progression of cyst development and renal insufficiency in accordance with Korean regulations on Risk Management Plan(RMP) and New Drug Re-examination. This survey is a post-marketing, prospective, single-arm, all-cases survey conducted on approved indication, usage, dosage.


Eligibility criteria: Inclusion Criteria:

1. 18 years and older patients with CKD(chronic kidney disease) stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease.
2. Patients who need to be prescribed by Investigators who got registered in Risk Management Plan.
3. Patients who have agreed and signed on conditions specified in Risk Management Plan.

Exclusion Criteria:

1. Patients with known or suspected hypersensitivity to tolvaptan or chemically related structures such as benzazepines or to any ingredient of the drug
2. Patients requiring urgent intervention to raise serum sodium acutely.
3. Inability of the patient to sense or appropriately respond to thirst.
4. Hypovolemic hyponatremia
5. Concomitant use of strong CYP3A(Cytochrome P450, family3, subfamily A) inhibitors
6. Anuric patients
7. Volume depletion patients
8. Hypernatremia patients
9. Women who are pregnant or possibly pregnant and lactation
10. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
11. Patients who are applicable to permanent discontinuation criteria prior to initiation of Samsca® Tablets

Primary outcomes:
measure: The incidence rate and the number of Adverse Events (AE) / Adverse Drug Response (ADR)
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Kim Med Clinic
state: Gyeongsangnam-do
Study officials:
References:
Clinical trial NCT00881686: Myocardial Protection With Adenosine Preconditioning
Official title: Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heart Defects, Congenital
Cardiac Surgical Procedures
Myocardial Reperfusion Injury
Adenosine
Keywords: Ischemic Preconditioning, Myocardial
Adenosine
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2009-04-15
Enrollment: 238
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adenosine has been proved to be an important mediator of myocardial protection induced by ischemic preconditioning. The hypothesis of this study is that adenosine preconditioning can provide additional myocardial protection in the setting of pediatric open heart surgery with cardioplegia and cardiopulmonary bypass.

Detailed description: Adenosine has been used for diagnosis and treatment of cardiovascular diseases for many years. New progresses in myocardial protection in the settings of acute myocardial infarction treatment put forward the its clinical use to a broader field. But the safety and effectiveness of its use in myocardial protection in the setting of open heart surgery has not been investigated intensively. Our primary results suggested that adenosine preconditioning could decrease the release of myocardial serum markers, such as cTnI. This study will focus on the safety and effectiveness of adenosine in the field of pediatric myocardial protection during surgery repair of congenital heart defects with CPB and cardioplegia.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of congenital heart defects eligible for surgery treatment under cardiopulmonary bypass and cardioplegia
* Body weight less than or equals to 10kg

Exclusion Criteria:

* Cardiac surgery is performed without cardiopulmonary or cardioplegia
* Body weight more than 10Kg

Primary outcomes:
measure: Outcome Measure: all cause mortality
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes:
measure: The time of ICU stay
timeFrame: within the first 30 days (plus or minus 3 days) after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Institute of Cardiovascular Surgery, Xijing Hospital
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Zhenxiao Jin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04594486: Medical Treatment for Acute Appendicitis
Official title: Long Term Results of Medical Treatment for Acute Appendicitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with acute appendicitis

Brief summary: Medical treatment for acute appendicitis

Detailed description: Patients with clinically and radiologically approved acute appendicitis will be treated medically. The main aim of the study is to define the long term results of medical treatment for acute appendicitis. Patients will be followed by clinical visits and recurrences will be recorded.

Eligibility criteria: Inclusion Criteria:

* clinically and radiologically approved acute appendicitis
* approved and signed the informed consent form

Exclusion Criteria:

* perforated cases
* cases with peritonitis
* patient wish for surgical treatment
* allergy to drugs used in medical treatment of acute appendicitis

Primary outcomes:
measure: recuurence
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: Uşak University
Study officials:
affiliation: Uşak University Medical School
name: Barış Sevinç, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00953186: Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers
Official title: Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Foot Ulcer
Healing
Keywords: Diabetes
Foot ulcer
Neuropathy
Ischemia
Lead sponsor: Mrs. Thelma Zoegas Foundation
Sponsor class: OTHER
Collaborators: name: Lund University
name: Region Skåne Sweden
name: Gorthons Foundation Helsingborg Sweden
First posted: 2009-08-06
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers as compared to placebo in patients with diabetes mellitus and chronic foot ulcers.


Eligibility criteria: Inclusion Criteria:

* diabetes mellitus,
* foot ulcer with duration \> 3 months,
* treatment at Diabetes foot clinic for \> 2 months,
* vascular surgical intervention had not been recommended for the affected lower limb.

Exclusion Criteria:

* severe obstructive pulmonary disease,
* malignancy and untreated thyrotoxicosis),
* current drug or alcohol misuse,
* vascular surgery in the lower limbs within the last two months,
* participation in another study or suspected poor compliance.

Primary outcomes:
measure: Ulcer healing
timeFrame: 3, 6, 9, 12, 18, 24 months
Secondary outcomes:
measure: Amputationrate
timeFrame: 6, 12, 24 months
measure: time to ulcer healing
timeFrame: 24 months
measure: QoL
timeFrame: 3, 6, 12, 18, 24 months
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Dept Anesthesiology, Helsingborg Hospital
Study officials:
affiliation: Inst Clinical Sciences in Lund, Lund University, Sweden
name: Magnus Löndahl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inst Clinical Sciences in Lund, Lund University, Sweden
name: Per L Katzman, ass prof, MD
role: STUDY_CHAIR
References:
citation: Londahl M, Katzman P, Nilsson A, Hammarlund C, Sellman A, Wykman A, Hugo-Persson M, Apelqvist J. A prospective study: hyperbaric oxygen therapy in diabetics with chronic foot ulcers. J Wound Care. 2006 Nov;15(10):457-9. doi: 10.12968/jowc.2006.15.10.26970.
citation: Londahl M, Katzman P, Hammarlund C, Nilsson A, Landin-Olsson M. Relationship between ulcer healing after hyperbaric oxygen therapy and transcutaneous oximetry, toe blood pressure and ankle-brachial index in patients with diabetes and chronic foot ulcers. Diabetologia. 2011 Jan;54(1):65-8. doi: 10.1007/s00125-010-1946-y. Epub 2010 Oct 19.
citation: Londahl M, Katzman P, Nilsson A, Hammarlund C. Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care. 2010 May;33(5):998-1003. doi: 10.2337/dc09-1754.