louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05034211: A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural
Official title: A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Pain
Epidural
Pain, Labor
Keywords: dural puncture
programmed intermittent bolus
labor analgesia
Lead sponsor: Aretaieio Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intermittent epidural bolus technique opens a new era of interest for maintaining labor anlagesia. The study examines programmed intermittent epidural bolus technique on a scheduled basis to provider-administered bolus anlgesia on patient request, after a dural puncture epidural technique.

Detailed description: After dural puncture, an epidural catheter will be placed on nulliparous women between 38 and 40 weeks of gestation presenting for labor . All will receive an test dose of 3ml lidocaine 2%, for properly checking the catheter placement and then an initial dose of 10ml ropivacaine 0,2% with 2 mcg/ml fentanyl. After that, women will be randomly assigned on two groups. Both groups will be receiving the same dose of analgesia (10ml ropivacaine 0,2% plus 1,5 mcg/ml fentanyl. However, one group will be receiving them on scheduled time intervals as programmed intermittent boluses every 60minutes and the other only on patient request for pain relief.

Pain scores, satisfaction, time for adequate analgesia, bromage scores,apgar scores, fetal arterial blood gases, time for delivery and type of delivery will be studied

Eligibility criteria: Inclusion Criteria:

-nulliparous women

* 38th week of gestation

Exclusion Criteria:

* patient refusal to have an epidural
* patient refusal to participate
* contraindication for epidural
* ASA\>3
* neurologic deficit/impairment
* allergy on local anesthetic chronic pain syndromes

Primary outcomes:
measure: Total local anesthetic and opioid administration
timeFrame: 24hours
Secondary outcomes:
measure: time needed for delivery
timeFrame: 24hours
measure: total patient satisfaction
timeFrame: 24hours
measure: apgar score
timeFrame: 24hours
measure: Bromage score
timeFrame: 24hours
measure: type of delivery
timeFrame: 24hours
measure: neonatal arterial blood gases
timeFrame: 24hours
measure: time for sucessful level of analgesia
timeFrame: 24hours
measure: Pain score(NRS scale)
timeFrame: 24hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital
state: Attiki
Study officials:
References:
Clinical trial NCT03995511: Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery.
Official title: Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery. A Prospective Longitudinal Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensory Deficit
Keywords: Sensory deficit
Orthognathic surgery
Mandibular osteotomy
Inferior alveolar nerve
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
Collaborators: name: King Saud Medical City
First posted: 2019-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical study investigates the sensation deficit in the lower lip and chin area after surgical correction of lower jaw deformity.

The primary null hypothesis is: Lower jaw osteotomy cause no sensory deficit in the inferior alveolar nerve.

The secondary null hypothesis is: Concurrent genioplasty with sagittal split does not increase the risk of sensory deficit in the inferior alveolar nerve.


Eligibility criteria: Inclusion Criteria:

* Patients with lower jaw deformity requiring bilateral sagittal split osteotomy

Exclusion Criteria:

* Medically compromised patients
* Previous neurosurgical procedure
* Patients on chronic medications
* Patients with a mental or psychiatric disorder
* Pregnant and lactating female
* Previous neurosensory deficit due to trauma, pathology, or surgery
* Patients with facial pain disorders including trigeminal neuralgia, temporomandibular disorder, or atypical facial pain

Primary outcomes:
measure: Light touch sensation first week
timeFrame: One week after the surgery
measure: Light touch sensation first month
timeFrame: One month after the surgery
measure: Light touch sensation three months
timeFrame: Three months after the surgery
measure: Pinprick sensation first week
timeFrame: One week after the surgery
measure: Pinprick sensation first month
timeFrame: One month after the surgery
measure: Pinprick sensation three months
timeFrame: Three months after the surgery
measure: Static two points discrimination first week
timeFrame: One week after the surgery
measure: Static two points discrimination first month
timeFrame: One month after the surgery
measure: Static two points discrimination three months
timeFrame: Three months after the surgery
measure: Warm/cold test first week
timeFrame: One week after the surgery
measure: Warm/cold test first month
timeFrame: One month after the surgery
measure: Warm/cold test three months
timeFrame: Three months after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Elm University
Study officials:
affiliation: Riyadh Elm University
name: Ra'ed G Salma
role: STUDY_DIRECTOR
References:
Clinical trial NCT04420611: Use of Endogenous Melatonin and 6-hydroxymelatonin as Biomarkers for CYP1A2
Official title: Use of Endogenous Melatonin and 6-hydroxymelatonin as Biomarkers for CYP1A2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women

Brief summary: An observational study comprising 4 sessions will be conducted in 12 healthy volunteers. During each study session (sessions 1 to 4), a 12-hour urine collection during the night (21h-9h) will be carried out by each participant. The first urine in the morning will be collected separately to be analysed independently of the 12-hour collection. 24 hours before the start of the night urine collection, volunteers will be asked to refrain from consuming alcohol and caffeinated drinks/foods, with the exception of session 3. Conversely, in session 3, subjects will be asked to drink or eat caffeinated food/drinks 24 hours prior to night-time urine collection (at least one cup of coffee or a can of Coca-Cola®).

After each 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Understanding of French language and ability to give a written informed consent

Exclusion Criteria:

* Inability to refrain from alcohol or methylxanthine-containing beverages and foods for 24 hours
* Sensitivity to coffee or CocaCola®
* Irregular (i.e. non-daily or inconstant dosages) intake of medication or food of a CYP1A2 modulator (including tobacco)

Primary outcomes:
measure: Validation LC-MS/MS analytical method
timeFrame: 1 month
Secondary outcomes:
measure: Intra- and inter-variability
timeFrame: 3 days (day 1, day 4 and day 30)
measure: Urine correlation
timeFrame: 4 days (day 1, day 4, day 15 and day 30)
measure: Correlation melatonin and caffeine
timeFrame: 4 days (day 1, day 4, day 15 and day 30)
measure: Impact caffeine intake
timeFrame: 1 day (day 15)
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Youssef Daali, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06803511: Dietary Acid Load and Oral Health Quality in Adolescents
Official title: Investigating the Relationship Between Dietary Acid Load and Oral Health-Related Quality of Life in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent
Keywords: Dietary acid load
oral health
quality of life
adolescents
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 374
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample in Türkiye

Brief summary: This study investigates the link between dietary acid load and oral health-related quality of life in 374 high school students (226 females, 148 males). Participants completed a demographic questionnaire, the OHIP-14 scale, and provided 24-hour dietary recalls. Dietary acid load was assessed using PRAL and NEAP calculations. Data analysis was performed with SPSS 24 to explore the impact of diet composition on adolescents' oral health.

Detailed description: Introduction: Oral health plays a crucial role in the psychological and physical development of children and adolescents. The composition of the diet consumed significantly affects oral health.

Objective: This study aimed to examine the relationship between dietary acid load and oral health-related quality of life in adolescents.

Method: A total of 374 high school students (226 females, 148 males) participated in the study. Adolescents completed a demographic questionnaire and the Oral Health Impact Profile-14 (OHIP-14) scale, and 24-hour retrospective food consumption records were collected. Dietary acid load was assessed by calculating potential renal acid load (PRAL) and net endogenous acid production (NEAP) based on macronutrient and micronutrient intake from food records. Data analysis was conducted using the SPSS 24 software package.

Eligibility criteria: Inclusion Criteria:

* 14-18 ages

Exclusion Criteria:

* those with diagnosed eating disorders
* those with diagnosed psychiatric
* those with diagnosed cancer

Primary outcomes:
measure: Oral Health Impact Profile-14 Score
timeFrame: Baseline
measure: Calculation of Dietary Acid Load
timeFrame: Baseline
Secondary outcomes:
measure: Sociodemographic characteristics
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Body weight
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
References:
Clinical trial NCT02373228: Optimization of Music Compression
Official title: Optimization of Music Compression for People With Hearing Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Phonak AG, Switzerland
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hearing impaired persons suffer from inferior music perception with and without hearing aids. Hearing aids, however, are primarily designed to improve speech intelligibility not music enjoyment. This study investigates the potential benefit of signal processing strategies that are optimized for music. The purpose of this study is to improve music compression for hearing impaired people.


Eligibility criteria: Inclusion Criteria:

* Female and male adults between 18 and 99 years
* German-speaking
* Symmetric, mild to severe, ski-slope hearing loss
* Binaural hearing aid user without frequency lowering
* Informed Consent as documented by signature

Exclusion Criteria:

* Have taken part in a study at Phonak within 4 months prior to the first session
* People with mental-health problems
* People whose audiogram is older than 12 months and it is not possible make a reliable measurement
* Very limited motor activity or mobility

Primary outcomes:
measure: Benefit of signal processing for music perception
timeFrame: 3 months
Secondary outcomes:
measure: Performance in music discrimination tests
timeFrame: 3 months
Other outcomes:
Locations:
city: Staefa
country: Switzerland
facility: Phonak AG
state: Zürich
Study officials:
References:
citation: Kirchberger M, Russo FA. Dynamic Range Across Music Genres and the Perception of Dynamic Compression in Hearing-Impaired Listeners. Trends Hear. 2016 Feb 10;20:2331216516630549. doi: 10.1177/2331216516630549.
Clinical trial NCT02357628: Effect of Regulated Oxygen-Enriched Negative Pressure Therapy (RO-NPT) On Soft Tissue Wound Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wounds and Injuries
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-02-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presenting at the Hillel Yaffe Medical Center for treatment of hard-to-heal wounds that have been selected for RO-NPT.

Brief summary: The investigators believe that regulated oxygen-enriched negative Pressure Therapy (RO-NPT) will be beneficial in the reduction or elimination of anaerobic infection in hard-to-heal soft tissue wounds.


Eligibility criteria: Inclusion Criteria:

* Patients with hard-to-heal wounds

Exclusion Criteria:

* Everyone else

Primary outcomes:
measure: Wound Closure
timeFrame: One Month
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Moris Topaz, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05358028: Effect of Hand Arm Bimanual Intensive Technique Including Lower Extremity (HABIT-IL) on Hemiplegic Cerebral Palsy
Official title: Comparison of Hand Arm Bimanual Intensive Technique With and Without Lower Extremity on Functional Status of Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: Hand arm bimanual intensive technique
Hemiplegic cerebral palsy
Functional status
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the functional status of upper extremity using HABIT \& HABIT-ILE. And to compare the effects of HABIT with and without lower extremity technique on functional status of hemiplegic cerebral palsy

Detailed description: Hemiplegic cerebral palsy children have impairments in bimanual coordination above and beyond their unilateral impairments .Hand-arm bimanual intensive therapy tends to show a constructive impact on hand function in children with hemi paretic cerebral palsy.

Hand-Arm Bimanual Intensive Therapy (HABIT) designed for children with unilateral CP, which when combines bimanual upper extremity training with activities involving the trunk and lower extremities making it HABIT-ILE.

A bimanual training program that continuously focusses on postural control and lower limb functional activity is all covered in HABIT-ILE Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) involves the concepts of motor skill learning and intensive training to both the UE and LE.

However it is not known that whether combined upper and lower extremity training in an intensive protocol is more efficacious or not thus Rationale of this study would be to figure out that if an intensive protocol is devised involving upper and lower extremities both would it be more product full or not. This study would be significant in a way that we know cerebral palsy is a lifelong challenging condition for both children and their caregivers thus new and emerging treatments can be fruitful for progression.

Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of hemiplegic cerebral palsy
* GMFCS level 2,3,4
* Ashworth scale 0-2

Exclusion Criteria:

* History of recent orthopedic surgery
* History of seizures
* Visual impairment

Primary outcomes:
measure: six minute walk test
timeFrame: 6 weeks
measure: Gross motor function measure
timeFrame: 6 week
measure: Box And Block
timeFrame: 6 weeks
measure: Assisting hand Assessment scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mirpur
country: Pakistan
facility: Mohi Ud Din Teaching Hospital (Mirpur AJK)
state: Azad Kashmir
Study officials:
affiliation: Riphah International University
name: Nadia Azhar, MS-NMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06713928: Effectiveness of Dog-Assisted Therapy on Compliance and Home Oral Hygiene Activities in Disabled Patients
Official title: Effectiveness of Dog-Assisted Therapy on Compliance and Home Oral Hygiene Activities in Disabled Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disabilities
Dog Therapy
Oral Hygiene, Oral Health
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recent scientific studies have shown how interaction with an animal can alleviate particular conditions of stress and conflict, thus representing a solid support for minor patients with social behavior problems or with physical or mental disabilities. In this co-therapy, a fundamental role is played by the relationship that is established between the human being and the animal, a very particular relationship capable of bringing about positive changes, in both members, but especially in the man who, benefiting from this push for change, can improve his own situation, whatever it is, and follow with greater interest and involvement the actual therapy activities proposed by the team that is following him.


Eligibility criteria: Inclusion Criteria:

* Patients had to be between 5 and 16 years old;
* Patients with disability;
* Non-collaborating or with limited collaboration (Frankl Scale 1 or 2);
* Patients with a Plaque Control Record (PCR) of 40% or more;
* Patients with partial autonomy in home oral hygiene procedures.

Exclusion Criteria:

* Patients with fear of dogs;
* Patients with dog hair allergy;
* Patients with infectious disease;
* Tetraplegic and visually impaired subjects.

Primary outcomes:
measure: Plaque Control Record (PCR)
timeFrame: 1 month
Secondary outcomes:
measure: Emotional record
timeFrame: 1 month
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza
Study officials:
References:
Clinical trial NCT00533728: Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma
Official title: A Phase I Study to Determine the Safety and Effect of Soluble Beta-Glucan (SBG) in Combination With Rituximab and COP/CHOP in Patients With Non'Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Biotec Pharmacon ASA
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety of soluble beta-glucan (SBG) in combination with antibody and chemotherapy treatment in patients with non-Hodgkin-s lymphoma.


Eligibility criteria: Inclusion Criteria:

1. CD20 positive B-cell non-Hodgkin's lymphoma
2. Treatment with rituximab and CHOP or COP
3. Performance status 0 or 1 according to the WHO scale (Appendix)
4. Expected lifetime of more than 12 weeks
5. Age ≥ 18 years
6. The patient must be able and willing to comply with the study procedures, and signed and dated informed consent must be obtained

Exclusion Criteria:

1. Women who are pregnant or breast-feeding. For fertile women, a negative pregnancy test must be provided during the screening test. Women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation
2. Lymphoma involvement of central nervous system
3. Reduced bone marrow function defined by leukocyte counts \< 3.0 x 109/l, neutrophil counts \< 1.5 x 109/l, thrombocyte counts \< 100 x 109/l or hemoglobin \< 10 g/dl
4. Reduced liver function defined by bilirubin \> 1.5 x upper limit of normal (ULN) or ASAT/ALAT ≥ 3 x ULN
5. Reduced renal function defined by serum creatinine ≥ 2 x ULN

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet, Kreftklinikken Radiumhospitalet
Study officials:
affiliation: Oslo University Hospital
name: Gustav Lehne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: