louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06876194: The Effect of Music on the Sedation Quality Among Children in the Emergency Department.
Official title: The Effectiveness of Music on The Procedural Sedation and Analgesia Quality Among Children in The Emergency Department.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sedation
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 84
Sex: ALL
Minimum age (years): 0
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children presenting to the emergency department frequently experience anxiety and may undergo various painful procedures. While sedative agents are administered to these patients, they do not consistently provide adequate relief to keep the child calm and cooperative during the procedures. Implementing non-pharmacological interventions, such as music, might enhance the efficacy of sedation, resulting in a better experience for these patients and more favorable outcomes.

Detailed description: This is an interventional single-blinded randomized clinical trial on children presenting to the emergency department of Imam Khomeini Hospital in Tehran. The estimated sample size is 42 patients in each group considering a 5% margin of error and 80% power. The efficacy of analgesia and sedation and adverse effects are measured using a predefined form. for the description of qualitative data, frequency will be used and for quantitative data, the T-Test, ANOVA, mean and SD will be employed. For examining differences between the two groups, Chi-Square, T-Test, and ANOVA will be utilized.

Eligibility criteria: Inclusion Criteria:

* Children between 0-14 years of age
* Requiring analgesia or sedation for medical procedures

Exclusion Criteria:

* Lack of consent from parents or legal guardian of the child
* Hearing impairment
* Any developmental disorder

Primary outcomes:
measure: Sedation depth
timeFrame: Interval between start to the end of the procedure, an average of 30 minute
Secondary outcomes:
measure: Adverse effect
timeFrame: Interval between injection to the end of recovery for 2 hours
measure: Recovery condition
timeFrame: Interval between the end of the procedure to the full recovery for 2 hours
measure: Physicians' satisfaction
timeFrame: Interval between start to the end of the procedure, an average of 30 minute
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: IKHC
Study officials:
affiliation: Tehran University of Medical Sciences
name: Hadi Mirfazaelian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05105594: Causes of Kinesiophobia in Lymphedema
Official title: Investigation of Causes of Kinesiophobia, Fatigue and Quality of Life in Patients With Lower Extremity Lymphedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema
Keywords: lymphedema, Kinesiophobia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, the reason for the fear of movement in patients with lymphedema will be investigated and recommendations will be given to the patients to eliminate it.


Eligibility criteria: Inclusion Criteria:

* Those between the ages of 18-65
* To be diagnosed with lymphedema in the unilateral lower extremity
* Volunteering to work
* Not having orthopedic disorders in the lower extremities

Exclusion Criteria:

* Not volunteering to participate in the research
* Having bilateral lower extremity lymphedema
* Having an active infection
* Having a mental cognitive disorder
* Being unable to communicate and cooperate

Primary outcomes:
measure: Kinesiophopia Causes Scale
timeFrame: 10 minutes
measure: functional assessment of chronic illness therapy
timeFrame: 10 minutes
measure: Lymphedema Quality of Life Questionnaire
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: Çankaya
Study officials:
References:
Clinical trial NCT01241994: Automatic Adaptive System Dialysis (AASD)
Official title: Automatic Adaptive System Dialysis (AASD) for Dialysis Related Hypotension and Intolerance: a Prospective Long-term Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dialysis Intolerance
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2010-11-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: AASD is a new dialysis technique based on the use of a mathematical model of intradialytic solutes and fluid kinetic, for the automatic elaboration of dialysate sodium and ultrafiltration rate profile. The aim of dialysate sodium and ultrafiltration rate profile is to obtain the higher stabilization of intradialytic extra cellular compartment, in consideration of end session targets: body weight and final patient's natremia. In this multicenter prospective controlled randomized trial the primary end-point is the clinical efficiency validation of AASD on intradialytic hypotension but also on thirst, cramps, headache, nausea, vomiting, hypotensive events observed in basal treatment (HD or HDF).


Eligibility criteria: Inclusion Criteria:Patients in HD/HDF (bicarbonate dialysis/hemodiafiltration) for at least 6 months

* aged more than 18 years
* on chronic thrice-weekly HD
* symptomatic hypotension during at least 30% of dialysis sessions on basal treatment in the last month before admission or/and 1 hypotension /week
* disequilibrium symptoms (cramps, headache, nausea, vomiting, hypotensive events) in at least 30% of dialysis sessions on basal treatment
* dialysis session time: 4 hours (as much as possible)
* Signed inform consent form
* Patients having no vascular access related problems (bi-ponction, blood flow rate 300ml/min)

Exclusion Criteria: Patients in a pregnant state

* Patients whose life expectancy is less than study period
* Patients with progressive acute pathology (neoplasia...)
* Patients included in an other protocol
* Psychiatric patients or patients unable to consent or unable to follow the study

Primary outcomes:
measure: number of intradialytic hypotensive events
Secondary outcomes:
measure: percentage of dysequilibrium symptoms
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: policlinico S. Orsola
Study officials:
References:
citation: Coli L, Ursino M, Dalmastri V, Volpe F, La Manna G, Avanzolini G, Stefoni S, Bonomini V. A simple mathematical model applied to selection of the sodium profile during profiled haemodialysis. Nephrol Dial Transplant. 1998 Feb;13(2):404-16.
citation: Ursino M, Coli L, Brighenti C, De Pascalis A, Chiari L, Dalmastri V, La Manna G, Mosconi G, Avanzolini G, Stefoni S. Mathematical modeling of solute kinetics and body fluid changes during profiled hemodialysis. Int J Artif Organs. 1999 Feb;22(2):94-107.
Clinical trial NCT02769494: The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
Official title: The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Crohn's Disease
Oral Ulcer
Keywords: Oral ulcer
Crohn's disease
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 0
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: This study aims at evaluating efficacy and safety of topical using Mesalazine Sustained-Release Tablets in in the treatment of oral ulcers in patients with Crohn's disease.

Detailed description: The study will include three phases: screening, treatment and follow-up.

Screening: This phase will last a maximum of 7 days and subjects eligibility will be evaluated after informed consent signature.

Treatment: Subjects are randomly assigned to treatment and will be treated for 7 days. Daily oral ulcer area and symptoms were recorded during the treatment period. A randomization visit will take place on day 0 and an end-of-treatment visit will take place between day 6 and 8.

Follow-up: 28 days after the end of treatment. Efficacy of treatment was evaluated by the oral ulcer remission or decreasing.

Eligibility criteria: Inclusion Criteria:

* Age between 18\~65, both gender.
* Patients with oral ulcer and confirmed Crohn's disease.

Exclusion Criteria:

* Contraindications to study drugs.
* Underwent or will accept oral Surgery.
* Patients are not able to sign the informed consent or not comply with the study protocol.
* Planning for pregnancy, pregnancy and lactating women.
* Enrolled in other clinical trials in the past 30 days.
* Patients with concurrent / new other serious diseases will affect the effectiveness and safety evaluation.

Primary outcomes:
measure: oral ulcer healing
timeFrame: the 7 Days of treatment.
measure: oral ulcer recurrence
timeFrame: the 28 Days after the end of treatment.
Secondary outcomes:
measure: symptoms effective rates
timeFrame: At the 7 Days of the treatment, and the 28 Days after the end of treatment.
measure: adverse events
timeFrame: From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Degistive Disease of Xijing Hospital, Fourth Military Medical University
name: Ying Han, Ph. D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00545194: Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess
Official title: Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Ripening
Labor, Induced
Keywords: Prostaglandin E2
Intravaginal gel
Bishop score
Induction of labor
randomized trial
Vaginal insert
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2007-10-17
Enrollment: 446
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare two different preparation


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* cephalic presentation
* gestation of more than 37 Weeks confirmed by ultrasound
* Bishop score less than 7
* Informed consent

Exclusion Criteria:

* previous cesarean section (scarred uterus)
* polyhydramnios
* multiple pregnancy
* fetal malformation

Primary outcomes:
measure: Percentage of vaginal deliveries within the 48 hours after cervical ripening
timeFrame: 48 hours
Secondary outcomes:
measure: Proportion of total vaginal deliveries
timeFrame: 48 hours
measure: Vaginal deliveries at 12 hours, 24 hours and 36 hours
timeFrame: 48 hours
measure: Number of hyperkinesia with or without fetal heart rate monitoring abnormalities
timeFrame: 48 hours
measure: Number of hypertonia with or without fetal heart rate monitoring abnormalities
timeFrame: 48 hours
measure: Apgar score at 5 min less or equal 7
timeFrame: 48 hours
measure: Apgar score at 10 min less or equal 7
timeFrame: 48 hours
measure: Arterial pH less or equal 7.20
timeFrame: 48 hours
measure: Arterial base excess more than 12
timeFrame: 48 hours
measure: Number of maternal post-partum haemorrhage
timeFrame: 48 hours
measure: Time to reach 3cm cervical dilatation
timeFrame: 48 hours
Other outcomes:
Locations:
city: Tours
country: France
facility: Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Study officials:
affiliation: Tours Universiity Hospital
name: Franck Perrotin, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyrenas S, Clason I, Ulmsten U. In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour. BJOG. 2001 Feb;108(2):169-78. doi: 10.1111/j.1471-0528.2001.00039.x.
citation: Strobelt N, Meregalli V, Ratti M, Mariani S, Zani G, Morana S. Randomized study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low-Bishop-score pregnancy. Acta Obstet Gynecol Scand. 2006;85(3):302-5. doi: 10.1080/00016340500523685.
citation: El-Shawarby SA, Connell RJ. Induction of labour at term with vaginal prostaglandins preparations: a randomised controlled trial of Prostin vs Propess. J Obstet Gynaecol. 2006 Oct;26(7):627-30. doi: 10.1080/01443610600903362.
Clinical trial NCT00842894: Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia
Official title: A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 3421
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from speciality practice settings who have been deemed appropriate to receive biphasic insulin aspart 30 or insulin detemir as new treatment and as part of routine out-patient care by the prescribing physician.

Brief summary: This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.


Eligibility criteria: Inclusion Criteria:

* After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
* Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Primary outcomes:
measure: Incidence of serious adverse drug reactions (SADRs)
timeFrame: after 26 weeks
Secondary outcomes:
measure: Number of all minor hypoglycaemic events
timeFrame: during 4 weeks preceding each visit
measure: Number of all major hypoglycaemic events
timeFrame: during 13 weeks preceding each visit
measure: HbA1c
timeFrame: after 26 weeks
measure: Percentage of subjects to reach HbA1c below 7.0%
timeFrame: after 13 weeks and 26 weeks
measure: The effect on glycaemic control as measured by FPG (fasting plasma glucose)
timeFrame: after 13 weeks and 26 weeks
measure: The effect on glycamic control as measured by PG profile
timeFrame: after 13 weeks and 26 weeks
measure: Change in body weight
timeFrame: after 13 weeks and 26 weeks
Other outcomes:
Locations:
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00848094: Radiation Dose Escalation Study for Advanced Liver Cancer
Official title: Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
radiation therapy
3-dimensional conformal radiation therapy (3-DCRT)
intensity modulated radiation therapy (IMRT)
active breathing control
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC).


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed or clinically diagnosed HCC
* Surgically unsectable or medically inoperable diseases, or surgery declined by the patient
* Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases
* Associated with cirrhosis of Child-Pugh A
* Karnofsky performance status (KPS) of ≥ 70
* Normal renal function and adequate bone marrow reservation
* Tolerate active breathing control (ABC)

Exclusion Criteria:

* Child-Pugh B or C liver cirrhosis score
* Previous radiotherapy to the liver
* Indistinct tumor boundary in CT/MRI image

Primary outcomes:
measure: Toxicity was graded using the CTCAE 3.0. Dose-limiting toxicity was defined as acute ≥ grade 3 hepatic or gastrointestinal toxicity, or any grade 5 treatment-related adverse event, or late complication of radiation-induced liver disease.
timeFrame: 4 months
Secondary outcomes:
measure: 1,2 and 3 years survival
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Guoliang Jiang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01179594: A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
Official title: A Phase IV, 2x2 Factorial, Double Blind Study of 48 Versus 96 Weeks of PEGASYS 180µg, With or Without 24 Weeks of Entecavir in Adult Patients With HBeAg Negative Chronic Hepatitis B.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a \[Pegasys\], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is \<500 patients.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/= 18 years of age
* chronic hepatitis B for \>/= 6 months
* HBeAg negative at screening
* adequate renal function

Exclusion Criteria:

* antiviral therapy for chronic hepatitis B within the previous 6 months
* hepatitis A, C, D or HIV infection
* treatment with systemic acyclovir or famciclovir within the previous 6 months
* decompensated liver disease (Childs B-C)
* history or evidence of a medical condition associated with chronic liver disease

Primary outcomes:
measure: Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)
timeFrame: 48 weeks after the end of treatment
Secondary outcomes:
measure: Correlation early HBsAg response - response end of treatment/follow-up
timeFrame: every 6 weeks up to week 48, every 12 weeks therafter
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03009994: Exteriorization Versus Non-exteriorization of the Uterus During Repair of Uterine Incision in a Repeated Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrapartum Hemorrhage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 1024
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cesarean section is one of the most frequently performed major operations worldwide. It accounts for between 1% and 70% of deliveries depending on the facilities or country assessed. In Egypt, the cesarean section rate is 22%, with higher rates seen in private hospitals. In 2015 ,incidence of cesarean section rate in Woman Health Hospital in Assiut university is 51.3% of all deliveries.

Different Operational techniques For cesarean section have been defined aimed at reducing surgical time, making the surgery easier and more efficient, lowering costs,decreasing the risk of adverse effects and postoperative morbidity, as well as length of hospital stay.

Also, Intraoperative blood loss is one of important complications during cesarean section. A systematic review included twenty one studies, in 2011, revealed that increase incidence of intraoperative blood loss and blood transfusion with increase number of cesarean deliveries.also anemia in the pregnancy increase maternal morbidities included intraoperative blood loss. In Egypt, prevalence of Iron deficiency anemia among pregnant women about 51% of pregnant women.

After baby born by cesarean section and the placenta has been extracted, uterine incision is sutured either by temporary removal of the uterus from the abdominal cavity (exteriorization of the uterus) to facilitate uterine incision repair or it is repaired within the abdominal cavity (in situ repair). There had been few randomized controlled trials comparing intraoperative and postoperative morbidity following exteriorization of the uterus with non-exteriorization. The conclusions drawn from these trials have been conflicting.


Eligibility criteria: Inclusion Criteria:

* Pregnant women in 28 weeks
* Women who will undergo repeated lower segment cesarean section

Exclusion Criteria:

* First cesarean section
* Placenta previa.
* Rupture uterus.
* Classical caesarean section.(upper segment cesarean section)
* Sever Preeclampsia.
* Chorioamnionitis.
* prolonged or obstructed labour.
* Fibroid.
* Polyhydramnios.
* Multiple pregnancy.

Primary outcomes:
measure: Intraoperative blood loss (mL)
timeFrame: 20 minutes
measure: Postoperative Hemoglobin (gm/L)
timeFrame: 20 minutes
Secondary outcomes:
measure: Duration of operation (minutes)
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References: