louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05727449: General or Spinal Anesthesia for Cesarean Delivery
Official title: Comparison of The Effects of General and Spinal Anesthesia for Cesarean Delivery on Maternal and Fetal Outcomes: A Retrospective Analysis of Data in a Third Level Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia for Cesarean Delivery
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 862
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The pregnant women and their babies in 01.01.2019 - 31.12.2019.

Brief summary: During the cesarean deliveries, one of the anesthesia techniques, regional anesthesia or general anesthesia (GA) is prefered. Spinal anesthesia (SA) is preferred among the regional anesthesia methods because the onset of anesthesia is faster and muscle relaxation is more suitable for cesarean section anesthesia. Although both methods have advantages and disadvantages, the anesthesia method to be chosen may vary depending on the condition of the mother and fetus.

The goal of this retrospective clinical trial is to compare general and spinal anesthesia in cesarean deliveries. The main questions it aims to answer are:

* Are the anesthesia techniques effect maternal outcome?
* Are the anesthesia techniques effect fetal outcome?


Eligibility criteria: Inclusion Criteria:

The pregnant women who delivered with cesarean section

Exclusion Criteria:

* The pregnant women who delivered with spontan vaginal delivery.

Primary outcomes:
measure: Apgar 1st minute score
timeFrame: 1st minute after birth
measure: Apgar 5th minute score
timeFrame: 5th minute after birth
measure: Umbilical Cord Blood pH
timeFrame: at the time of birth
measure: Umbilical Cord Blood PCO2
timeFrame: at the time of birth
measure: Umbilical Cord Blood HCO3
timeFrame: at the time of birth
measure: Umbilical Cord Blood Lactate
timeFrame: at the time of birth
measure: Umbilical Cord Blood Base Excess
timeFrame: at the time of birth
measure: need for neonatal intensive care
timeFrame: up to 24 hours
measure: need for maternal intensive care
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
References:
Clinical trial NCT05561049: Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma
Official title: Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma With Renal Dysfunction in Real-World: A Non-interventional Prospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Newly Diagnosed Multiple Myeloma
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2022-09-30
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: 1. newly diagnosed MM;
2. age over 18 years, male or female;
3. glomerular filtration rate (eGFR) \< 40 mL/min
4. patients who completed at least one course of treatment were included in the safety observation;
5. Patients who completed at least 2 courses of treatment were included in the efficacy observation;

Brief summary: This is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTD) Regimens in NDMM patients with renal dysfunction in real-world clinical practice. The data collected in this trial are for subjects with NDMM and renal dysfunction treated with D-VTd regimen and consist of 2 treatment phases, efficacy and safety data from induction phase and consolidation phase.


Eligibility criteria: Inclusion Criteria:

1. newly diagnosed multiple myeloma;
2. age over 18 years, male or female;
3. glomerular filtration rate (eGFR) \< 40 mL/min
4. Patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed before any trial process;
5. patients who completed at least one course of treatment were included in the safety observation;
6. Patients who completed at least 2 courses of treatment were included in the efficacy observation;

Exclusion Criteria:

1. acute and chronic renal insufficiency not caused by myeloma;
2. are receiving any other investigational drug or investigational medical device;
3. Patients with other cancers confirmed before MM diagnosis, except cervical carcinoma in situ or scaly cell carcinoma of the skin and basal cell carcinoma that are considered cured for more than 3 years before enrollment;
4. patients who do not complete a course of DVTd treatment for any reason, unless permanent discontinuation or death due to the drug;

Primary outcomes:
measure: Very good partial response (VGPR) rate
timeFrame: 28 days after consolidation therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02269449: Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial
Official title: RAP and BEAT Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Coronary Intervention
Keywords: transradial intervention
radial artery
Lead sponsor: NPO International TRI Network
Sponsor class: NETWORK
Collaborators: name: European Cardiovascular Research Center
name: Duke Clinical Research Institute
First posted: 2014-10-21
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).


Eligibility criteria: Inclusion Criteria:

* Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IRB.
* Patient who is expected to diagnose by coronary artery angiography or followed by PCI.
* Patient must agree to undergo all protocol-required follow-up examinations.
* Patient who can accept radial access.

Exclusion Criteria:

* Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
* Hemodialysis patient
* STEMI

Primary outcomes:
measure: Radial artery occlusion
timeFrame: Day 1
measure: Local bleeding from puncture site
timeFrame: Day 1
Secondary outcomes:
measure: Procedure success rate
timeFrame: Day 1
measure: Vascular access site complication
timeFrame: Day 1
measure: Radial spasm during the index procedure
timeFrame: Day 1
measure: Total Procedure Time
timeFrame: Day 1
measure: Total Amount of Contrast Dye
timeFrame: Day 1
measure: Total Radiation Doses
timeFrame: Day 1
measure: Device failure for the assigned sheath introducer
timeFrame: Day 1
measure: Pain score
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04964349: Efficacy of Jessener Solution Versus Intralesional Steroid in Treatment of Alopecia Areata
Official title: Efficacy of Jessener Solution Versus Intralesional Steroid in Treatment of Alopecia Areata
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Alopecia Areata
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: there are 2 patches of alopecia areata in the same patient one treated with intralesional injection of corticosteroid and the other one will be treated by jessenersolution
Primary purpose: TREATMENT

Brief summary: Alopecia areata is believed to be an autoimmune disease. Treatment primarily relies on intralesional and topical corticosteroids. This study was conducted to evaluate Jessener Solutionas a potential therapeutic modality of Alopecia Areataversusintralesional steroid as regards the efficacy, safety, tolerability, and patients' satisfaction.

Detailed description: Background Alopecia areata is believed to be an autoimmune disease resulting from a breach in the immune privilege of the hair follicles causing non scarring hair loss.Treatment primarily relies on intralesional and topical corticosteroids.Up till now, there is nouniversally proven therapy that induces and maintains remission of Alopecia Areata in all patients.

Aims The Aim of Study is to evaluate the efficacyof Jessener solution versus intralesional steroid in treatment of Alopecia Areata.

Patients and Methods The study will include 40 patients diagnosed clinically and dermoscopically as Alopecia Areata with more than two patches of alopecia areata were included. Two treatment modalities with intralesional corticosteroid and topical Jessener Solutionas were performed in two randomly selected patches. Three sessions were done, 3 weeks apart and were followed-up for three months. Evaluation was done using Mac Donald Hull and Norris grading system , Serial photographs and dermoscopic , trichoscopic examination every month will be done and patient will be score.

Eligibility criteria: Inclusion Criteria:

* 1.Alopecia Areatamultilocuolaris.2.Age from18-50years old. 3.Wash out period is two months. 4.Ophiasis pattern alopecia areata.

Exclusion Criteria:

* Age less than 12 yearsand more than 40years old. 2.Patient under treatment.3.Patients having another dermatological condition affecting thescalpas eczema.4.Patients with psychiatric disorders.5.Pregnant and lactating females.

Primary outcomes:
measure: Effecacy of topical jessener solution in treatment of alopecia areata
timeFrame: 6 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alazhar faculty of meidicine
Study officials:
affiliation: Alazhar faculty of medicine
name: Ahmed Elshahid, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05130749: Infection Prevention and Control Practices Regarding COVID-19
Official title: Infection Prevention and Control Practices Among Primary Healthcare Nurses Regarding COVID-19 in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Keywords: Infection Prevention
Infection control
Primary Healthcare
Nurses
Saudi Arabia
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 198
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: healthcare practitioners and community health nurses who worked at the aforementioned centres. There are 800 nurses in total.

Brief summary: Background: Healthcare providers, particularly nurses, are at risk of infection as part of the COVID-19 epidemic chain since they assist in the disease's containment. By recognising the risk factors for infection and implementing suitable measures to reduce these risks, all reasonable efforts should be taken to control the spread of infection to them. The major aim of the present study was to determine the level of infection prevention and control practises used by primary healthcare nurses in Saudi Arabia during the COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

* Male and female healthcare practitioners with at least one year of experience and who worked in all areas of primary healthcare facilities during the COVID-19 epidemic.

Exclusion Criteria:

* Healthcare providers that are unwilling to participate in the present study have been eliminated

Primary outcomes:
measure: Distribution of study participants by gender, age group, marital status, and income level in a self-reported questionnaire.
timeFrame: Once within 6 weeks
Secondary outcomes:
measure: Detection of source of knowledge regarding COVID-19 prevention methods
timeFrame: Once within 6 weeks
Other outcomes:
measure: Circumstances when Healthcare providers practice infection prevention tasks in settings.
timeFrame: Once within 6 weeks
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
References:
Clinical trial NCT03767049: Readmissions of Lung Transplant Patients in ICU.
Official title: Readmissions of Lung Transplant Patients in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplant; Complications
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2018-12-06
Enrollment: 153
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: Lung transplant recipients who required ICU readmission.

Brief summary: A multi-centre, prospective and observational study was carried out from August 2012 to June 2016 in five Spanish tertiary-care university hospitals with well-established lung transplant programs: Vall d'Hebron (Barcelona), Marqués de Valdecilla (Santander), 12 de Octubre (Madrid), CHUAC (A Coruña), and Reina Sofía (Córdoba).

The study population comprised all consecutive adult lung transplant recipients who required ICUr (after \>7 days post-transplant discharge from ICU) during august 2012 - June 2016 (4-yr period).


Eligibility criteria: Inclusion Criteria:

* All consecutive adult lung transplant recipients who required ICU readmission (after \>7 days post-transplant discharge from ICU) during august 2012 - June 2016 (4-yr period).

Exclusion Criteria:

* ICU readmission \< 8 days post-transplant discharge from ICU.
* ICU readmission for early postoperative care following lung transplantation.

Primary outcomes:
measure: Causes of ICU readmission in LT adults
timeFrame: Augist 1. 2012 - June 30, 2016
measure: Predictors of ICU and hospital mortality.
timeFrame: Augist 1. 2012 - June 30, 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: 0
name: Cristopher Alan Mazo Torre, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00999349: Therapeutic Effects of Silymarin in Patients With B-thalassemia Major
Official title: Combined Therapy of Silymarin and Desferrioxamine in Patients With B-thalassemia Major: a Randomized Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Beta-thalassemia Major
Iron Overload
Keywords: iron overload condition
regular desferrioxamine administration
receiving continuous blood transfusions
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Madaus Inc
First posted: 2009-10-21
Enrollment: 140
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective and iron chelating activities. The present study has been designed to investigate the therapeutic activity of orally administered silymarin in patients with thalassemia major under conventional iron chelation therapy. A 6-month randomized, double-blind, clinical trial was conducted in 140 beta-thalassemia major patients in two well-matched groups. Patients are randomized to receive a silymarin tablet (140 mg) three times a day plus conventional desferrioxamine therapy or the same therapy but a placebo tablet instead of silymarin. Clinical laboratory tests of iron status and liver function are assessed at the beginning and the end of the trial.


Eligibility criteria: Inclusion Criteria:

* Presence of major Beta-thalassemia
* Age 12 years or older
* Iron overload condition (serum ferritin levels between 1000-5000 ng/mL) Regular desferrioxamine administration (50 mg/kg)
* Continuous blood transfusions
* Negative CRP test

Exclusion criteria:

* Hepatitis B or C infection
* Positive HIV test
* Chronic renal or heart failure
* Iron chelating therapy with other iron chelators

Primary outcomes:
measure: Serum ferritin level
timeFrame: after 3 months and 6 months from beginning of the trial
Secondary outcomes:
measure: Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels
timeFrame: At the beginning and the end of the trial
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
affiliation: Isfahan University of Medical Sciences, moayedi@med.mui.ac.ir
name: Behjat Moayedi, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gharagozloo M, Moayedi B, Zakerinia M, Hamidi M, Karimi M, Maracy M, Amirghofran Z. Combined therapy of silymarin and desferrioxamine in patients with beta-thalassemia major: a randomized double-blind clinical trial. Fundam Clin Pharmacol. 2009 Jun;23(3):359-65. doi: 10.1111/j.1472-8206.2009.00681.x. Epub 2009 May 7.
Clinical trial NCT06407349: Effect of Communication Board on Functional Communication of Children With Cerebral Palsy
Official title: Effect of Communication Board on Functional Communication of Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy (CP)
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: My aim of the research is to compare the effect of traditional therapy with the AAC device and identify if the AAC device is more effective for CP children than traditional therapy.


Eligibility criteria: Inclusion Criteria:

* Children of both genders with Cerebral Palsy age group 8 years-12 years
* Children with Cerebral Palsy having mild to moderate cognitive impairment and communication impairment
* Children with comorbid conditions (epilepsy, microcephalia)
* Children with physical abilities of functional Pointing, One Step Command
* Following, Vocalization, and Imitation.

Exclusion Criteria:

* Children with comorbid conditions (visual impairment, hearing impairment

Primary outcomes:
measure: Functional Communication
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Special Education Academy
state: Punjab
Study officials:
affiliation: Riphah International University
name: Maimoona Ismail
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03657849: Evaluation of 19-gauge vs 21-gauge EBUS TBNA in Assessing Thoracic Lymphadenopathy
Official title: Evaluation of 19-gauge vs 21-gauge EBUS TBNA in Assessing Thoracic Lymphadenopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enlarged Lymph Nodes (Excluding Infective)
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective diagnostic accuracy study
Primary purpose: DIAGNOSTIC

Brief summary: This study compares the yield of 19-gauge needles vs 21-gauge needles during EBUS TBNA procedures.

Detailed description: Endobronchial ultrasound-guided transbronchial needle aspirate (EBUS-TBNA) is a technique used to take samples of body tissue inside the chest without having to undergo an operation.

During this procedure, a special telescope (called a bronchoscope) is inserted through the mouth into the airways. Ultrasound technology allows the doctor to see the structures just outside the airway. By being able to see the structures outside the airway, the doctor is able to safely pass a fine needle through the airway to take samples of abnormal tissue.

EBUS-TBNA is used to take samples of tissue from the mediastinum. The mediastinum is the part of the chest between the lungs, and contains the heart, gullet, windpipe and lymph nodes. This area of the body is usually difficult to access without open surgery, hence the use of EBUS-TBNA. EBUS-TBNA may be used to investigate enlarged lymph nodes. This may be due to tuberculosis, sarcoidosis or cancer.

Currently, smaller 21-gauge and larger 19-gauge needles are used during the EBUS-TBNA procedure at Regions Hospital. The purpose of this study is to find out which needle is better in finding the explanation for the enlarged lymph nodes, and any follow up procedures that may be necessary if the investigators are unable to get enough tissue during the EBUS-TBNA procedure (surgical sampling, radiological sampling, and/or follow-up imaging).

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Able to provide informed consent
* Referred for EBUS TBNA sampling at Regions Hospital

Exclusion Criteria:

* On therapeutic warfarin, Plavix, or ticagrelor in the past 5 days
* INR\>1.8 or platelets \<50K

Primary outcomes:
measure: Diagnostic Yield
timeFrame: 6 months
measure: Diagnostic Yield
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
affiliation: Regions Hospital
name: Firas S Elmufdi, MBBS
role: PRINCIPAL_INVESTIGATOR
References: