louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01091779: Changes of Upper and Lower Limb Blood Flow and Vascular Resistance in Hyperbaric Spinal Anesthesia for Transurethral Resection of the Prostate (TURP) Using Duplex Ultrasonography: Comparison of Normotensive and Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transurethral Resection of the Prostate (TURP)
Keywords: Male patients scheduled to have spinal anaesthesia for TURP
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 40
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients scheduled elective transurethral surgery

Brief summary: Changes of Upper and Lower Limb Blood Flow and Vascular Resistance in Hyperbaric Spinal Anesthesia for TURP Using Duplex Ultrasonography: Comparison of Normotensive and Hypertensive Patients.


Eligibility criteria: Inclusion Criteria:

* males (\> 65 yr) were scheduled to have spinal anaesthesia for TURP

Exclusion Criteria:

* patients with peripheral vascular disease
* chronic venous insufficiency
* prior deep vein thrombosis (DVT) defined by the presence of thrombosis on duplex or the presence of ultrasonographic signs indicating a previous DVT
* body mass index \>35
* prior lower limb surgery due to arterial or venous trauma
* history of diabetes or autonomic deficiency.

Primary outcomes:
measure: venous flow velocity, blood volume flow, resistance index, pulsatility index, diameter of popliteal vein
timeFrame: 10 minutes after spinal block
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Kil HK, Suk EH, Lee MH, Bang EC, Hong JY. Venous flow dynamics during spinal block in normotensive and hypertensive elderly patients: a duplex ultrasonographic study. Acta Anaesthesiol Scand. 2012 Mar;56(3):376-81. doi: 10.1111/j.1399-6576.2011.02617.x. Epub 2012 Jan 19.
Clinical trial NCT04509479: National Tunisian Registry of Valvulopathies (NATURE-VALVE)
Official title: National Tunisian Registry of Valvulopathies (NATURE-VALVE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Valvular Heart Disease
Valvular Stenosis
Valvular Insufficiency
Keywords: Valvular
Heart
Aortic
Mitral
Tricuspid
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Tunisian Society of Cardiology and Cardiovascular Surgery
First posted: 2020-08-12
Enrollment: 3637
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: Patients with valvular disease

Brief summary: The National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \& ICH (International Conference on Harmonisation) requirements.


Eligibility criteria: Inclusion Criteria:

* Patients originated from Tunisia
* Signed informed consent
* Patients with at least one of the following conditions :

  1. moderate to severe native mitral and / or aortic and / or tricuspid native valve disease
  2. and / or a history of a previous percutaneous or surgical valve intervention
  3. and / or a history of infectious endocarditis

Exclusion Criteria:

* Congenital valve diseases not including bicuspid aortic valve
* Isolated pulmonary valvulopathies

Primary outcomes:
measure: Valvulopathies incidence
timeFrame: at inclusion
Secondary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: at 6 months of follow-up
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: The Tunisian Society of Cardiology and CardioVascular Surgery
Study officials:
affiliation: Tunisian Society of Cardiology and Cardiovascular Surgery
name: Fathia Mghaieth, MD
role: STUDY_CHAIR
affiliation: Tunisian Society of Cardiology and Cardiovascular Surgery
name: Lilia Zakhama, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01408979: Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia
Official title: Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Severe Preeclampsia
Keywords: Severe preeclampsia
magnesium sulfate
anticonvulsivant
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother.

Detailed description: Magnesium sulfate (MgSO4) is certainly the ideal drug for prevention and control of eclamptic seizures. However, there is no consensus on the appropriate duration of prophylaxis with this anticonvulsant postpartum.The objective of the present study is to compare effectiveness of 12 hours of magnesium sulfate versus 24 hours (standard treatment) in stable patients with preeclampsia.

Eligibility criteria: Inclusion Criteria:

* Pre-eclampsia;
* Puerperium.

Exclusion Criteria:

* Associated maternal diseases;
* Use of illicit drugs or other medications that might interfere with maternal hemodynamics;
* Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.

Primary outcomes:
measure: Need to continue therapy for another 12 hours.
timeFrame: 24 hours
Secondary outcomes:
measure: Satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: IMIP
state: Pernambuco
Study officials:
affiliation: IMIP
name: Melania M Amorim, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maia SB, Katz L, Neto CN, Caiado BV, Azevedo AP, Amorim MM. Abbreviated (12-hour) versus traditional (24-hour) postpartum magnesium sulfate therapy in severe pre-eclampsia. Int J Gynaecol Obstet. 2014 Sep;126(3):260-4. doi: 10.1016/j.ijgo.2014.03.024. Epub 2014 May 10.
Clinical trial NCT00561379: Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab
Official title: Frontline Therapy of Diffuse Large B Cell Lymphoma of the Adult ( 18 to 60 Years Old): Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14 -Rituximab. Multicentric Randomized Prospective Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma, Large-Cell, Diffuse
Keywords: Diffuse Large B Cell Lymphoma
not previously treated
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2007-11-21
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III or IV with 1 to 3 adverse prognostic factors according to the International prognostic index. Patients with eligibility criteria and who gave informed consent will be randomised between CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous stem cell support. The aim of the study is to compare the Event free survival between the two arms and to gain insight into the prognostic significance of several biological markers gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA profile and BCL é expression).

Detailed description: Diffuse Large B Cell Lymphoma not previously treated

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 et ≤ 60 and male and female
* Diffuse large B cell lymphoma according to WHO classification phénotype B CD 20 +
* Stage I et II tumor bulk \> 7 cm and stage III et IV Ann Arbor.
* Non previously treated
* HIV négative
* Signed informed consent

Exclusion Criteria:

* Age \< 18 and/or \> 60 ans
* NHL not DLBCL
* Lymphoblastic Lymphoma
* Burkitt's Lymphoma
* Low grade Lymphoma transformed
* Primary CNS Lymphomal
* Post- transplantation Lymphoma
* CD20 negative
* Ann Arbor stage I or II without tumor bulk \> 7 cm
* Previous treatment
* HIV positive
* Contre-indication to Rituximab use according to SmPC
* Contre-indication to high dose chemotherapy due to organ failure not related to the lymphoma
* Cancer or history of cancer with the exception of in situ cancer of the cervix or non-invasive skin epithelioma
* Patient not able to understand the proposed treatments
* Refusal to sign the informed consent

Primary outcomes:
measure: 3 years Event-free survival ( Kaplan Meier method)
Secondary outcomes:
measure: 3 years overall survival
measure: Prognostic impact of: Level of expression of protéine bcl2 protein in tumor cells; FCGR3A genotype; génomic profile (DNA microarray)on response, survival, and Event-Free-Survival
measure: Cost
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Noel Milpied, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05371379: Multiple Ascending Dose Study of CM338 in Healthy Volunteers
Official title: A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.

Detailed description: The study included screening period, administration and safety follow-up period.

Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, aged ≥18 and ≤65 years.
* Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
* All clinical laboratory examination are normal, or abnormal without clinical significance.

Exclusion Criteria:

* Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.
* Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
* Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
* Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.

Primary outcomes:
measure: Incidence of Adverse Events (AEs).
timeFrame: Up to Week 12.
Secondary outcomes:
Other outcomes:
Locations:
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
Study officials:
References:
Clinical trial NCT01029379: Pharmacogenetics of Propofol and Depth of Anesthesia
Official title: The Effect of Pharamocogenetices on Anesthesia Induction With Propofol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Propofol
Keywords: propofol
depth of anesthesia
pharmacogenetics
Depth of anesthesia in correlation to plasma concentrations of propofol
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2009-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 patients, ASA classification 1 planned for elective surgery of at least 30 minutes duration

Brief summary: Propofol, (2,6-diisopropylphenol) is a short-acting anesthetic drug used for induction and maintenance of anesthesia.

The aim of this study is to evaluate plasma concentrations of propofol in relation to depth of anesthesia, measured by continuous EEG and to correlate plasma concentrations with genetic analyses of liver enzymes responsible for drug elimination.

Our hypothesis is that there is an individual requirement of Propofol plasma concentration depending on genetic differences in drug elimination.

200 patients, ASA classification 1, planned for elective surgery of a duration of at least 30 minutes will be included in this study.


Eligibility criteria: Inclusion Criteria:

* Healthy caucasian patents,
* (ASAclassification 1) planned for elective surgery,
* with body mass index 20-30,
* free from analgetic drug \> 12 hours prior to anesthesia

Exclusion Criteria:

* Pregnancy,
* Smoking,
* allergy to propofol or peanuts,
* alcohol abuse,
* non-caucasian

Primary outcomes:
measure: EEG pattern in correlation to clinical anesthesia
timeFrame: 20120101
Secondary outcomes:
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Department of Anesthesia and Intensive Care
Study officials:
References:
citation: Khan MS, Zetterlund EL, Green H, Oscarsson A, Zackrisson AL, Svanborg E, Lindholm ML, Persson H, Eintrei C. Pharmacogenetics, plasma concentrations, clinical signs and EEG during propofol treatment. Basic Clin Pharmacol Toxicol. 2014 Dec;115(6):565-70. doi: 10.1111/bcpt.12277. Epub 2014 Jul 19.
Clinical trial NCT02402179: Metabolic Availability of Tryptophan From White Maize
Official title: Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Tryptophan From White Maize Protein, in Young Adult Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: protein quality
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 7
Sex: MALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our objective is to determine the metabolic availability of Tryptophan in white maize using the indicator amino acid oxidation (IAAO) technique in adult men.

Detailed description: Our objective is to determine the metabolic availability of Tryptophan in white maize. Seven young, healthy, male adults will receive graded levels (13.2, 26.4, 39.7, 52.9) of tryptophan requirement of 3.78 mg/kg/d as a crystalline amino acid (AA) mixture and a porridge of white cornmeal protein respectively.

Eligibility criteria: Inclusion Criteria:

* Healthy Adult males (20-49years old).
* Stable body weight
* Not on any medications that could affect protein and amino acid metabolism e.g. steroids.

Exclusion Criteria:

* Recent weight loss within the last 3 months or on weight reducing diet.
* Unwillingness to participate or unable to tolerate the diet.

Primary outcomes:
measure: Metabolic Availability of Tryptophan in Corn
timeFrame: 9 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Senior Scientist
name: Paul Pencharz, MD, PhD,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rafii M, Elango R, Ball RO, Pencharz PB, Courtney-Martin G. Metabolic Availability of the Limiting Amino Acids Lysine and Tryptophan in Cooked White African Cornmeal Assessed in Healthy Young Men Using the Indicator Amino Acid Oxidation Technique. J Nutr. 2018 Jun 1;148(6):917-924. doi: 10.1093/jn/nxy039.
Clinical trial NCT02003079: Evaluating the Impact of Chronic Rhinosinusitis on the Health-Related Quality of Life Among Adults With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: St. Paul's Hospital, Canada
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 113
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult individuals over the age of 19 years with a definitive diagnosis of Cystic Fibrosis.

Brief summary: Individuals with Cystic Fibrosis (CF) have a defective protein, which is known as the cystic-fibrosis transmembrane regulator (CFTR). The CFTR transports salt and hydrates mucous. CFTR defects may result in the accumulation of thick mucous in the sinus cavities. As a result, the tiny hair-like structures that sweep mucous out of the sinuses cannot function properly, which can lead to recurrent infection and swelling of the sinus walls. When symptoms are persistent for more than 12 weeks, this is known as chronic rhinosinusitis (CRS). The symptoms that are associated with CRS are nasal discharge, congestion, facial pain or pressure and reduced sense of smell. CRS in non-CF patients affects a large number of individuals in Canada and has been found to be associated with poor quality of life. In the CF population the life expectancy is increasing but chronic disease like CRS is becoming increasingly prevalent. Investigators currently do not know the impact that CRS has on the health-related quality of life in adults with CF and how many suffer from symptoms. The investigators aim to determine the impact of CRS among adults with CF, in order to gain a better understanding of chronic disease among these individuals. The investigators strongly feel this research will improve the referral processes between Respirologists and Otolaryngologists, thereby improving treatment and quality of life for patients.


Eligibility criteria: Inclusion Criteria:

* 19 years of age or older
* Definitive diagnosis of cystic fibrosis from positive genetic or sweat chloride test
* Currently enrolled at the St. Paul's Cystic Fibrosis Clinic

Exclusion Criteria:

* Individuals unable to understand the purpose, methods and conduct of this study.
* Patients unwilling to provide informed consent.

Primary outcomes:
measure: Difference in Cystic Fibrosis-specific HRQoL score among those with and without CRS.
timeFrame: One clinic visit (30 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: St Paul's Sinus Center
name: Amin R Javer, MD FRCSC FARS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Habib AR, Buxton JA, Singer J, Wilcox PG, Javer AR, Quon BS. Association between Chronic Rhinosinusitis and Health-Related Quality of Life in Adults with Cystic Fibrosis. Ann Am Thorac Soc. 2015 Aug;12(8):1163-9. doi: 10.1513/AnnalsATS.201504-191OC.
Clinical trial NCT02493179: Efficacy Evaluation of the (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
Official title: Efficacy Evaluation of the Dose Regimen of Serratiopeptidase (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Trismus
Swelling
Inflammation
Lead sponsor: Hayat Pharmaceutical Co. PLC
Sponsor class: INDUSTRY
First posted: 2015-07-09
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy of dose regimen of serratiopeptidase (serodase 5 mg) as a prospective, randomized, parallel, double blind Placebo- controlled study.

Detailed description: A prospective, randomized, parallel, double blind Placebo- controlled study to examine the efficacy of dose regimen of serratiopeptidase (serodase 5 mg) on 112 males and females volunteers in the treatment of inflammation after third molar surgery, comparing drug treatment vs placebo over a period of 20 weeks To assess the dose effectiveness of the dose regimen of Serodase 5 mg; the primary outcomes are trismus and swelling while inflammation is a secondary outcome.the expected duration of participants participation will be around 5 days divided into 4 visits, the time point of the measurment are (0,2,4 and 5 days).

The results are expected to assess the improvement of the maximal interincisal distance, reduction of swelling and improvment in the sensation of post-operative pain.

Eligibility criteria: Inclusion Criteria:

* participants presented with impacted lower wisdom tooth needs Buccaneers flap with buccal and distal bone removal.
* male or female 18-50
* participant is willing and able to give informed consent for paricipation in the study.
* Able and willing and able with all study requirments.

Exclusion Criteria:

* other oral surgical procedures during the same session except the removal of supernumerary third molars.
* female subject who is pregnant or lactating
* subjects has participated in any clinical research study within the previous 8 weeks.
* subjects on anti coagulant drugs .
* Unwilling participants to continue the study and those with abnormality of wound healing process.

Primary outcomes:
measure: Trimus by measuring the interincisal distance
timeFrame: 5 days
measure: Swelling by using The Laskin method
timeFrame: 5 days
Secondary outcomes:
measure: Post-operative pain
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
References:
citation: Tamimi Z, Al Habashneh R, Hamad I, Al-Ghazawi M, Roqa'a AA, Kharashgeh H. Efficacy of serratiopeptidase after impacted third molar surgery: a randomized controlled clinical trial. BMC Oral Health. 2021 Mar 2;21(1):91. doi: 10.1186/s12903-021-01451-0.