louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02394041: Randomised Controlled Trial of the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy
Official title: A Randomised Controlled Multicenter Trial Evaluating the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Dystocia
Keywords: acupuncture
cervical dystocia
caesarean section
obstetric labor
randomized controlled trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The principal objective of the trial is to demonstrate that acupuncture could reduce the caesarean section rate for cervical dystocia.

Secondary objectives:

To demonstrate that acupuncture can:

* reduce morbidity, fetal mortality and duration of childbirth;
* reduce the cost of care, due to diminution of caesarean sections and duration of obstetric labor;
* to evaluate the tolerance.

Detailed description: In this trial, pregnant women with at least 37 weeks of amenorrhea will be randomized to traditional chinese acupuncture, sham acupuncture, or usual care only.

9 investigator sites will participate to this trial targeting to enrol 2220 patients in total. 1780 subjects will receive acupuncture treatment, either effective treatment or sham, whereas 400 patients will receive usual care only.

Acupuncture therapy consists in stimulations on specific skin points of the abdominal area, which are specific acupuncture points in traditional chinese medicine for the induction of obstetric labor, according to the professional recommendations of the French Acupuncture and Traditional Chinese Medicine College.

Each patient will have a 5-week follow-up in this trial.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years
* Signed informed consent
* Woman carrying one foetus only
* at 37 weeks (+/- 2 days) of amenorrhea
* Without contraindication to vaginal delivery

Exclusion Criteria:

* Prior history of caesarean section
* Non-cephalic presentation
* Fetal macrosomia
* Multiple pregnancy
* Chronic fetal hypoxia
* Placenta praevia
* Risk of neonatal contamination

Primary outcomes:
measure: Caesarean section rate
timeFrame: up to 37 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Cloud
country: France
facility: Department of Obstetrics, Hôpital Saint-Cloud
state: Hauts-de-Seine
Study officials:
affiliation: Department of Obstetrics, Hôpital Saint-Cloud
name: Denis COLIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01638234: Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis
Official title: Effectiveness of Melatonin Supplement in the Management of Sleep Disturbances in Children With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
eczema
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 48
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin may aid sleep and also has anti-inflammatory properties, and has been suggested in managing sleep disturbance in AD patients. However, there has been no large randomized controlled trials. Hence the objective of this double-blind randomized controlled study is to determine whether supplementing melatonin is effective in improving sleep problems in children with AD.


Eligibility criteria: Inclusion Criteria:

* Children between 1 and 18 years of age with mild to moderate AD, affecting at least 5% of total body surface area, and with sleep problems in the previous 3 months

Exclusion Criteria:

1. Those who had failed other systemic and/or topical immunosuppressive agents such as tacrolimus, methotrexate, or cyclosporine
2. Those who had received therapy for insomnia within 4 weeks before the baseline visit
3. Those who were, in the opinion of the investigator, known to be unreliable or noncompliant with medical treatment or appointments
4. Those who had drug abuse problems, mental health dysfunction, or other factors limiting their ability to cooperate fully
5. Those who were taking antihistamines, oral immunosuppressant medication, or antidepressant medication
6. Pregnant and lactating women and those who are presently planning to get pregnant
7. Those who had any other condition or earlier/current treatment which, in the opinion of the investigator, would render the participant ineligible for the study

Primary outcomes:
measure: Objective sleep measures as measured by actigraphs and SCORAD
timeFrame: 4 weeks
Secondary outcomes:
measure: urine and serum cytokines
timeFrame: 4 weeks
measure: total and allergen-specific IgE
timeFrame: 4 weeks
measure: sleep parameters measured by polysomnography
timeFrame: 4 weeks
measure: subjective improvement in symptoms
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jyh-Hong Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang YS, Lin MH, Lee JH, Lee PL, Dai YS, Chu KH, Sun C, Lin YT, Wang LC, Yu HH, Yang YH, Chen CA, Wan KS, Chiang BL. Melatonin Supplementation for Children With Atopic Dermatitis and Sleep Disturbance: A Randomized Clinical Trial. JAMA Pediatr. 2016 Jan;170(1):35-42. doi: 10.1001/jamapediatrics.2015.3092.
Clinical trial NCT02368834: Psychoeducation for the Parents of Attention Deficit Hyperactivity Disorder (ADHD) Children
Official title: Evaluation of a Psychoeducation Program for the Parents of Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 89
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study designed and evaluated a psychoeducation program for parents of ADHD children in terms of improving medication adherence and clinical benefits.

Detailed description: ADHD is the most common behavioral disorder with poor outcomes. Medication is the most important treatment for ADHD. The adherence to the medication is extremely low. This study aims to investigate the the effect of a psychoeducation program for parents of ADHD children. The investigators intent to recruit 80 ADHD families. They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in a psychoeducation program, which includes a presentation from a specialist in ADHD at the baseline, with parent manual provided, posters, and two group sessions at the end of the 2nd and the 4th weeks. The control group only receives general consultation. The knowledge towards ADHD and its treatment, parents' behavior intent, medication adherence, clinical symptoms, and parents' satisfaction will be assessed and compared at the end of the 1st and 3rd months after intervention.

Eligibility criteria: Inclusion Criteria:

* parents of ADHD children diagnosed with ADHD
* 6 - 16 years old;
* first referral to the hospital;
* candidate for medication according to both the doctor and the family

Exclusion Criteria:

* inappropriate for medication;
* being illiterate of the parent or the primary caregiver;
* unable to be followed-up.

Primary outcomes:
measure: Medication adherence rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
Study officials:
affiliation: Peking University Sixth Hospital
name: Li Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03839134: The Effectiveness of Soft Tissue Vibration in Reducing Pain of Local Anesthesia Injection in Adult Dental Patients
Official title: The Effectiveness of Automated Soft Tissue Vibration in Reducing Pain and Accelerating Action of Intraoral Local Anesthesia Injections in Adult Dental Patients. A Randomized Crossover Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthetics, Local
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The clinical trial will compare pain perception during dental local anesthesia injections with and without using soft tissue vibration device prior to injection. The primary goal is to test the effectiveness of such devices in pain/discomfort reduction during intraoral local anesthesia injections in various techniques (infiltration and block anesthesia).


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status class I
* Planned for multiple dental treatments in the maxilla and mandible bilaterally

Exclusion Criteria:

* Patients \<18 years old
* Pregnant ladies
* Smokers and alcoholics
* Patients on medications
* Drug abusers
* Never received dental treatment under local anesthesia before
* Patients with an acute infection with or without fever
* Patients with preoperative pain

Primary outcomes:
measure: Pain of needle penetration of buccal LA injection
timeFrame: 1-2 seconds after mucosal penetration
measure: Pain of anesthesia delivery during buccal LA infiltration
timeFrame: 30 seconds after LA solution delivery
measure: Pain of needle penetration of palatal LA injection
timeFrame: 1-2 seconds after mucosal penetration
measure: Pain of anesthesia delivery during palatal LA infiltration
timeFrame: 30 seconds after LA solution delivery
measure: Pain of needle penetration of IAN block LA injection
timeFrame: 1-2 seconds after mucosal penetration
measure: Pain of anesthesia delivery during IAN block LA injection
timeFrame: 30 seconds after LA solution delivery
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: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02060734: Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder
Official title: Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated disorder-a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Whiplash Injuries
Neck Pain
Keywords: Whiplash,
injection,
lidocaine,
sham needling
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury.

Detailed description: This is a double-blind, randomized controlled trial to determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury. Outcomes include pain, objective assessment, self-report function recovery, impact on work performance and globe perceived effects which will be assessed 5 minutes, 2 and 6 weeks following injection.

Eligibility criteria: Inclusion Criteria:

* fulfill the Grade II Quebec Task Force classification of WAD,
* with identifiable myofascial trigger points ( which occur with or without a taut band),
* reproduction of recognizable pain with sustained pressure ( up to 10 seconds) on trigger points
* aged 18 to 70
* a good understanding of informed consent and willing to attend this trial.

Exclusion Criteria:

* have serious injury such as fracture and internal bleeding
* suspicion of upper cervical instability or neurological deficits
* clinical evidence of radiculopathy
* a history of active cancer, central nerve disorder, blood clotting disorders, needle phobia
* anticoagulant medication user
* previous experience with any type of needling for myofascial pain

Primary outcomes:
measure: pain
timeFrame: 2 weeks following injection
Secondary outcomes:
measure: cervical range of motion
timeFrame: Immediately, 2 and 6 weeks after injection
measure: self-report neck disability
timeFrame: Immediately, 2 and 6 weeks after injection
measure: globe perceived effects
timeFrame: Immediately, 2 and 6 weeks after injection
measure: work performance
timeFrame: Immediately, 2 and 6 weeks after injection
measure: pain
timeFrame: 5 minutes following injection
measure: pain
timeFrame: 6 weeks following injection
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Department of physical medicine and rehabilitation, McMaster University
state: Ontario
city: Hamilton
country: Canada
facility: HHS (Juravinski Hospital Site)
state: Ontario
Study officials:
affiliation: McMaster University
name: Joy MacDermid, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06288334: Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children
Official title: Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Allergic Disease
Children
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease.


Eligibility criteria: Inclusion Criteria:

1. The informed consent form was voluntarily signed by the legal guardians of the subjects (children aged ≥8 years should participate in the informed consent process and sign the informed consent form).
2. Pediatric patients, whether they are outpatients or inpatients, who require oral cetirizine therapy.
3. The children was clinically diagnosed with allergic diseases such as eczema, urticaria, asthma, and allergic rhinitis.
4. Pediatric patients had not taken other antiallergic drugs 72 hours before screening.

Exclusion Criteria:

1. Abnormal liver function (ALT or AST \> 2 times the upper limit of normal).
2. Abnormal renal function (serum creatinine above the upper limit of normal or GFR \< 10 mL/min)
3. Electrolyte abnormalities (potassium or magnesium \< 0.8 times lower limit of normal, \> 1.2 times upper limit of normal)
4. Children who were allergic to cetirizine or had a history of serious adverse reactions.
5. Pediatric patients with unstable vital signs.

Primary outcomes:
measure: Plasma concentration
timeFrame: 0.5 ~ 48 hours before and after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Wei Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03887234: Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques
Official title: Arthroscopic Coracoclavicular Ligament Reconstruction Using Knot Hiding Titanium Implants: a Prospective Randomized Two-year Follow up Study Comparing Two Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AC Joint Dislocation
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 27
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized follow-up study. Two groups.
Primary purpose: TREATMENT

Brief summary: This study follows early wound healing using knot hiding titanium implants in coracoclavicular ligament reconstruction. A further aim is to compare two techniques where the semitendinosus tendon graft either runs through the coracoid drill hole or goes around the coracoid.

Detailed description: A modified arthroscopic technique for coracoclavicular ligament reconstruction was used based on a previous technique where the supportive device and the semi tendon graft share the clavicular and coracoid drill holes. A notable problem with the previous technique was large protruding suture knots on the washer and clavicle, which could predispose to wound infection. In this new modified technique, new implants were introduced. The new implant hides the suture knot and less foreign material is needed.

The purpose of this study is to follow the patients operated using the new implants with special attention to early clavicular wound healing. A further aim is to compare a technique where the semitendinosus graft runs through clavicular and coracoid drill holes versus a technique where the graft runs under the coracoid process.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of chronic acromioclavicular luxation

Exclusion Criteria:

Severe new trauma after the treatment

Primary outcomes:
measure: Total number of wound infections in the clavicular describing the safety of the used implant
timeFrame: two months
Secondary outcomes:
measure: Constant score, scale 0-100, 100 denoting excellent
timeFrame: Score is taken postoperatively and after two years follow-up
measure: Simple shoulder test, scale 0-12, 12 denoting excellent
timeFrame: Score is taken postoperatively and after two years follow-up
measure: Nottingham clavicle score, scale 20-100, 100 denoting excellent
timeFrame: Score is taken postoperatively and after two years follow-up
measure: Clavicular tunnel diameter
timeFrame: The measure is taken postoperatively and after two years follow-up
measure: Coracoclavicular distance
timeFrame: The measure is taken postoperatively and after two years follow-up
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Paavo Nurmi Centre, University of Turku
Study officials:
affiliation: University of Turku, Finland
name: Juha O Ranne, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03845634: Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease
Official title: Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Non-motor fluctuation
Lead sponsor: Assistive Technology Clinic, Canada
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
name: The Cleveland Clinic
name: University Health Network, Toronto
name: University of Michigan
name: Rush University
name: The Parkinson Study Group
First posted: 2019-02-19
Enrollment: 202
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals, both men and women, who have been diagnosed with idiopathic Parkinson's Disease and have motor and non-motor fluctuating symptoms are invited to participate in the study. To ensure a representative sample, subjects spanning the disease spectrum will be equally represented in terms of mild, moderate and advanced symptoms of PD.

Brief summary: Investigators have developed a comprehensive questionnaire that assesses the presence of non-motor fluctuations (NMFs) in individuals with Parkinson's disease (PD). To date, 189 participants with PD have been assessed for preliminary data analysis prior to developing the penultimate version. At this time the objectives are to: (i) assess the scale's internal consistency and item-to-total correlations; (ii) assess test-retest reliability; (iii) use factor analysis and reliability measures to guide item reduction; (iv) assess construct validity; and (v) assess the scales ability to discriminate between static non-motor symptoms and non-motor symptoms which fluctuate (vi) estimate the relative distribution of cognitive, psychiatric, autonomic, sleep and sensory NMFs in PD patients with motor fluctuations and their impact on quality of life in Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Idiopathic Parkinson's Disease (according to the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria)
* Stage of symptoms is mild, moderate or severe as per the Hoehn \& Yahr scale
* Have motor fluctuations
* Have non-motor fluctuations

Exclusion Criteria:

* Atypical Parkinsonism
* Lack of motor fluctuations
* Lack of English language proficiency in either subject or caregiver

Primary outcomes:
measure: Cronbach's Alpha
timeFrame: Baseline
measure: Item-to-total correlation
timeFrame: Baseline
measure: Inter-rater reliability
timeFrame: 1 week after Baseline
measure: Concurrent validity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Assistive Technology Clinic
state: Ontario
Study officials:
affiliation: Assistive Technology Clinic
name: Galit Kleiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01174134: The Effects of Study Products Containing Varying Quantities of Docosahexaenoic Acid (DHA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Levels of DHA in the Blood
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2010-08-03
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes

Brief summary: The clinical trial will provide a milk-based drink with constant amounts of nutrients but differing amount of Docosahexaenoic Acid (DHA).


Eligibility criteria: Inclusion Criteria:

* Participant is 18 to 36 months of age
* Participant's current weight and height within the 10th to 90th percentiles
* Parent/caregiver reports that participant consumes milk or a milk-based beverage on a daily basis
* Participant lives at home with parent(s) or other family member(s)
* Signed informed consent and authorization obtained to use and or disclose Protected Health Information (PHI)

Exclusion Criteria:

* Participant who is receiving any breast milk at time of randomization
* Participant with an active infection.
* Participant with a history of underlying disease, chronic disease, or congenital malformation which in the opinion of the Investigator is likely to interfere with the evaluation of the participant.
* Known or suspected intolerance to cow's milk protein
* Participant diagnosed with diabetes
* Participant is from a multiple birth and the sibling(s) are still living
* Participant with a sibling that has participated in this study.

Primary outcomes:
measure: Blood lipid levels of Docosahexaenoic Acid (DHA) at enrollment and after two months, assessment of usual DHA intake, and product acceptability and use
Secondary outcomes:
measure: Growth
measure: Determination of nutrient status, including iron and vitamin D status
measure: Adverse Events
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
Study officials:
affiliation: University of Kansas
name: Susan Carlson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: