louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03728894: Oral Sedation With and Without Nitrous Oxide
Official title: Oral Sedation With/Without Nitrous Oxide in Pediatric Dental Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Behavior, Child
Keywords: Midazolam
hydroxyzine
oxygen
behavior
child
tooth
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: blinded, randomized controlled trial, comparing two groups.
Primary purpose: TREATMENT

Brief summary: Aims: The objective of the current study was to evaluate the effectiveness of oral midazolam-hydroxyzine with/without nitrous oxide. Design: This was a randomized split mouth, cross over and triple-blinded clinical study. Thirty uncooperative healthy children aged six to nine, whose needed dental treatments.

Detailed description: The purpose of this study was to compare the efficacy of combining oral midazolam-hydroxyzine with/without N2O/O2 in sedating uncooperative schoolchildren undergoing dental treatment. Thirty uncooperative healthy children aged six to nine were randomly selected to receive either one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 100% O2 (regimen A), or one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 50% N2O/O2 (regimen B) in a crossover design. Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment phase (injection, rubber dam RD, operating high-speed handpiece with touching the tooth without drilling) and the treatment phase (drilling, restoration).

Eligibility criteria: Criteria: Inclusion Criteria:

* ASA Classification I.
* minimum weight of 18 kg
* uncooperative children scored 1 or 2 on Frankle Scale.
* requiring nonemergency, bilateral mandibular dental treatments under local anesthesia.

Exclusion Criteria:

* known allergy to midazolam and/or hydroxyzine.
* upper respiratory tract infection with nasal discharge.

Primary outcomes:
measure: Behavior improvement on the modified Houpt behavioral rating scale
timeFrame: Behavior will assess at the end of the session (about 30-90 min) by evaluating the sessions 's videotapes using overall assessment (range from 1 to 4, higher values represent a better outcome) of the modified Houpt behavioral rating scale
measure: Behavior improvement on the modified Houpt behavioral rating scale
timeFrame: Behavior assess after 30 min of oral medications administered by evaluate the sessions's videotapes using of Sleep,movement,Head/oral resistance,Cry,Verbal assessments(range1- 4,higher values is the better outcome)of modified Houpt behavioral scale
Secondary outcomes:
Other outcomes:
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University
Study officials:
affiliation: Tishreen University
name: Nabih Raslan, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT04185194: Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children
Official title: Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Treatment Side Effects
Keywords: myofascial pain syndrome, pain quality
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial
Primary purpose: TREATMENT

Brief summary: A topical anesthetic gel lidocaine has been widely used as a local anesthetic to reduce the pain and discomfort. It provides local analgesia by blocking the initiation and transmission of impulses. Lidocaine topical anesthetic gel allows the use of high concentrations of the anesthetic bases without concern about local irritation, uneven absorption or systemic toxicity (Argoff, 2000 ). So, the aim of this study is to compare between the effect of lidocaine phonophoresis and pulsed ultrasound in myofascial pain syndrome in swimmers children.

Detailed description: Fourty five children (athletic swimmers) participated in this study, and were classified into three groups ; First control group A : this group consisted of fifteen children were receiving traditional physical therapy program. Second study group B: this group consisted of fifteen children were receiving pulsed ultrasound in addition to traditional physical therapy program as the same as in group A. Third study group C: this group consisted of fifteen children were receiving lidocaine phonophoresis in addition to traditional physical therapy program as the same as in group A. Treatment program in the three groups applied three times a week for three successive months. The study was done in the outpatient clinic of Ismailiy Sporting Club, Ismailia, Egypt.

Eligibility criteria: Inclusion Criteria:

* • Age range from 10 to 14 years.

  * All children have regional neck pain complaint.
  * Tenderness in cervical trigger points in the midpoint of the upper border of trapezius muscle, from grade II to grade IV according to tenderness grading scheme (Hubbard and Berkoff, 1993) (Appendix I ) ● The diagnosis of an active MTrP in the upper trapezius according to (Ardiçet al . , 2002 and Bruno, 2005)

Exclusion Criteria:

* • Neurological disorders.

  * Dermatological disorders.
  * Acute trauma prior to the study.
  * Fibromyalgia, systemic disease and drug allergy history were excluded from the study.
  * Having myofascial trigger points injection.
  * Chronic pain in both sides of the body.

Primary outcomes:
measure: interleukin 6
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy,Cairo University
Study officials:
affiliation: Suez Canal University
name: Asser Sallam, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02657694: Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
Official title: Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Lead sponsor: FixHepC
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Worldwide, Hepatitis C Genotypes 1-6

Brief summary: REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is observing and collating the treatment course, safety profile, and outcomes of patients around the world who are choosing to self import generic versions of the Direct Acting Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.

Detailed description: The high prices of Hepatitis C Virus (HCV) Direct Acting Antiviral (DAA) medications in many countries have led patients to seek out less expensive generic alternatives.

The efficacy and safety of these generic medications has not been formally demonstrated in clinical practice.

The primary goal of REDEMPTION is to collate the clinical results of these generic medications.

The secondary goal is to answer efficacy questions for which there is currently insufficient trial data available - for example Sofosbuvir+Daclatasvir appears to be an inexpensive pan genotypic solution to treat HCV globally but this is supported by a total n of less than 1000, and in some common genotypes, such as HCV Genotype 2, by an n of only 52 making for a wide margin of error and a high degree of uncertainty.

Eligibility criteria: Inclusion Criteria:

Quantitative HCV RNA \> 100

Exclusion Criteria:

Contraindications to DAA medications

Primary outcomes:
measure: Sustained Virological Response 4 (SVR4) by Hepatitis C Virus (HVC) RNA Polymerase Chain Reaction (PCR)
timeFrame: 4-7 months
Secondary outcomes:
measure: Side Effects
timeFrame: 3-6 months
measure: Rapid Virological Response (RVR) by HCV RNA PCR
timeFrame: 4 weeks
measure: End Of Treatment (EOT) Response by HCV RNA PCR
timeFrame: 3-6 months
measure: Sustained Virological Response (SVR12) by HCV RNA PCR
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Hobart
country: Australia
facility: FixHepC
state: Tasmania
Study officials:
affiliation: ACRRM
name: James Freeman, MB,BS,BSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06799780: Study on Post-acute Myocardial Infarction Ventricular Defect: Outcome Evalutation in Relation to Surgical Timing
Official title: Multicenter Study on Post-acute Myocardial Infarction Ventricular Defect: Outcome Evalutation in Relation to Surgical Timing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction (MI)
Heart Disease
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing surgical repair of post-AMI ventricular septal defect between January 1, 2001 and December 31, 2021.

Brief summary: The main objective of the study is to identify the optimal surgical timing for the treatment of intraventricular defects after acute myocardial infarction.

Detailed description: Identify the optimal timing for the treatment of post-infarction ventricular defect, considering the time interval between the clinical-instrumental diagnosis and the surgical intervention.

Eligibility criteria: Inclusion Criteria:

* Patients over eighteen years of age
* Patients with post-myocardial infarction ventricular septal defect treated surgically
* Patients who have signed the informed consent

Exclusion Criteria:

* Patients with post-infarction ventricular septal defect treated with medical/conservative therapy
* Patients with ventricular septal defects not due to acute myocardial infarction

Primary outcomes:
measure: Identify the optimal timing for the surgical intervention.
timeFrame: Possible timing for surgery can be: onset of the infarction episode, hospital admission, before seven days from the acute myocardial infarction or after seven days from the acute myocardial infarction.
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
city: Udine
country: Italy
facility: Ospedale Santa Maria della Misericordia Udine
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi Varese
city: Barcellona
country: Spain
facility: Hospital Clinic Barcellona
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Luca Di Marco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01029080: Cerebrovascular Autoregulation During Sepsis
Official title: Dynamic Cerebrovascular Autoregulation During Sepsis and Sepsis-associated Delirium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Delirium
Keywords: Brain, blood flow
Measurement techniques, flow velocity waveform analysis
Monitoring, intensive care
Sepsis
transcranial doppler ultrasound (TCD)
Cerebrovascular autoregulation
sepsis-associated delir
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 30
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: All patients at intensive care unit were screened to symptoms that definate sepsis

Brief summary: The aim of the study is to correlate the dynamic cerebrovascular autoregulation by patients with sepsis with a sepsis-associated delirium.


Eligibility criteria: Inclusion Criteria:

* clinical symptoms of sepsis, severe sepsis and septic shock
* possibility for measurement of transcranial doppler ultrasound
* age over 18 years

Exclusion Criteria:

* preexisting cerebrovascular disease
* preexisting immunological disease
* traumatic brain injury
* intracranial infectious disease
* pregnancy

Primary outcomes:
measure: Disturbed cerebrovascular autoregulation correlates with sepsis associated delir
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between inflammatory parameters and disturbed cerebrovascular autoregulation
timeFrame: 1 year
measure: Correlation between inflammatory parameters and sepsis-associated delirium
timeFrame: 1 year
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University medical centre Mainz
Study officials:
References:
citation: Schramm P, Klein KU, Falkenberg L, Berres M, Closhen D, Werhahn KJ, David M, Werner C, Engelhard K. Impaired cerebrovascular autoregulation in patients with severe sepsis and sepsis-associated delirium. Crit Care. 2012 Oct 4;16(5):R181. doi: 10.1186/cc11665.
Clinical trial NCT03128580: Embryo Aneuploidies and Morphokinetics in Ovarian Stimulated and Non Stimulated IVF Cycles
Official title: Embryo Aneuploidies and Morphokinetics in Ovarian Stimulated and Non Stimulated Cycles. An Intrapatient Comparison Using Next Generation Sequencing in Biopsy of Blastocysts and Time Lapse Evaluation.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Euploid Embryos
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 38
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing In Vitro Fertilization treatment

Brief summary: The purpose of this study is to compare the number of euploid embryos obtained per metaphase II oocyte in unstimulated (modified natural cycles) and stimulated IVF cycles.

Detailed description: Effects of ovarian stimulation on human embryo quality is still a subject of study. When natural and stimulated cycles have been compared, no differences have been observed in terms of embryo cleavage capacity, oocyte and embryo aneuploidy rate or incidence of aneuploidy in aborted foetuses. When mild and conventional doses of gonadotropins have been compared, a higher proportion of good morphological quality embryos are observed in the former. On the contrary, we showed that ovarian stimulation does not increase significantly the embryo aneuploidy rate in IVF derived human embryos when unstimulated and stimulated cycles were compared in oocyte donors. In this study, we want to compare the embryo aneuploidy rate between unstimulated and stimulated cycles in infertile patients, subjected to both IVF cycles with blastocyst biopsy and NGS-PGS. A comparison of the morphokinetics will also be performed.

Eligibility criteria: Inclusion Criteria:

* Women
* 30-38 years old (inclusive)
* with regular menstrual cycles (25-35 days)
* AntiMülleriana Hormone \>5 pmol/L.
* Undergoing IVF treatment

Exclusion Criteria:

* BMI \>30 kg/m2
* repeated miscarriages
* implantation failure
* uterine or adnexal pathology
* Unable to be treated with gonadotrophins for the ovarian hyperstimulation
* history of low response to ovarian hyperstimulation
* participation in another study with PGS for monogenic pathology
* Cryptozoospermia in male partner

Primary outcomes:
measure: Comparison of the number of euploid embryos from Metaphase II oocytes in different cohorts of embryos.
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of embryo aneuploidies in two cohorts of embryos.
timeFrame: 30 days
measure: Morphokinetic evaluation of embryos in two different cohorts of embryos.
timeFrame: 30 days
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
city: Valencia
country: Spain
facility: Instituto Valenciano de Infertilidad Spain
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
References:
Clinical trial NCT06950762: Aesthetic Performance of Two Injectable Resin Composites in Class V Cavities: A Randomized Clinical Trial
Official title: Aesthetic Performance of Two Injectable Resin Composites in Class V Cavities: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Restoration of Carious Class v Anterior Teeth
Keywords: Giomer based injectable composite
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using bioactive injectable resin composite in anterior class v carious lesions can provide better aesthetic outcome and marginal integrity by releasing multiple ions, including fluoride. This offers better marginal integrity due to presence of S-PRG fillers


Eligibility criteria: Inclusion Criteria:

1. Age 20-60 years.
2. Co-operative participants approving to participate in the study.
3. Male or female patients.
4. Medically free participants.
5. Moderate or high caries risk participants.

Exclusion Criteria:

1. Systemic disease or severe medical complications.
2. Participants with a history of allergy to any component of restorations will be used in the study.
3. Lack of compliance
4. Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits

Primary outcomes:
measure: Marginal discoloration using FDI criteria
timeFrame: 12 Month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04027062: Impact of Diabetes Continuing Education on Primary Health Care Physicians' Knowledge, Attitudes and Practice
Official title: Impact of Diabetes Continuing Education on Primary Health Care Physicians' Knowledge, Attitudes and Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabete Mellitus
Keywords: Diabetes, Continuing education, Attitude, Practice, Health care physicians
Lead sponsor: King Khalid University
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 65
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective is to evaluate the effectiveness of a continuing education program on the Knowledge, Attitudes and Practices of primary health care physicians towards a high quality of diabetes care in Aseer region, Saudi Arabia.

Detailed description: Background:

Diabetes is one of the rapidly growing chronic health conditions across the world. Healthcare providers still continue to face difficulties in delivering optimal care and education worldwide. Thus, continuing education is needed to improve Knowledge, Attitudes and Practices of physicians.

Objective: To evaluate the effectiveness of a continuing education (CE) program on the Knowledge, Attitudes and Practices of primary health care physicians (HCPs) towards a high quality of diabetes care.

Design and Methods:

This is a quasi-experimental design composed of pre-test post-test uncontrolled experimental design. The study will include all PHC physicians registered in health sectors of Abha and Khamis Musheet cities, Aseer Region. The physicians will be invited to attend a CE program. All participants will fill out a questionnaire before and after the intervention. The change in knowledge and attitudes of the participants will be measured at the end of the program. After 4 months, the practice of physicians will be assessed through retrospective review of patient's files.

Impact:

Education programs could positively influence the knowledge, beliefs and attitudes of healthcare workers toward a high quality of diabetes care, which in turn plays a major role in improving clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* all PHC physicians registered in health sectors of Abha and Khamis musheet cities, Aseer Region
* willing to provide informed consent to participate in the study

Exclusion Criteria:

* physicians worked at hospital
* other health care professional (non-physicians)

Primary outcomes:
measure: Percent of change of knowledge, attitude and practice of primary healthcare physicians
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05554562: Adductor Strength in Athletes Suffering a Groin Injury
Official title: Adductor Strength Assessment With Different Procedures for Athletes Suffering a Groin Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Groin Injury
Keywords: multidirectional sport
groin pain
adductor strength
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 50
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: athletes from multidirectional sports (football, basketball, hockey, etc) currently suffering a groin injury

Brief summary: assess the difference in adductor peak strength evaluated with different instruments. Hand held dynamometer vs force frame

Detailed description: This study aims to compare the difference in adductor strength output performed by athletes suffering a groin injury between two different assessment methods. Previous studies have observed that add strength differs depending on the evaluation method. Isometric strength can be measured with hand held dynamometer or with force plates (forceframe). Wether one method is better in order to differenciate adductor strength between healthy and injured limb is not known to date.

Eligibility criteria: Inclusion Criteria:

* Suffer a groin injury during the assessment period
* Accept participating in the study

Exclusion Criteria:

-

Primary outcomes:
measure: handheld dynamometer strength
timeFrame: november 2022 to june 2023
measure: forceframe strength
timeFrame: november 2022 to june 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Universidad de Oviedo
state: Asturias
Study officials:
affiliation: Universidad de Oviedo
name: Hugo Olmedillas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00309062: Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis
Official title: A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, Bet v 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Birch Pollen Allergy
Keywords: Allergy
Birch pollen
Recombinant
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2006-03-31
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: Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis


Eligibility criteria: Inclusion Criteria:

* Positive Skin Prick Test reaction to birch pollen
* Positive RAST result to birch pollen
* Positive Provocation Test result to birch pollen

Exclusion Criteria:

* Serious chronic diseases
* Other perennial allergies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Allergopharma GmbH & Co. KG
Study officials:
name: Annemie Narkus, M D
role: PRINCIPAL_INVESTIGATOR
References: