louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02717637: Oxycodone in Serum After Postoperative Oral Oxycodone in Caesarean Sections Under Spinal Anesthesia
Official title: Gastrointestinal Uptake of Oxycodone After Caesarean Section in Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesic Adverse Reaction
Cesarean Delivery Affecting Newborn
Keywords: oxycodone, caesarean, spinal anesthesia
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with single fetus in cephalated position admitted for elective caesarean section in spinal anesthesia

Brief summary: All patients undergoing an elective caesarean section under spinal anesthesia will, according to the hospital routines, receive 10 mg oxycodone slow-release tablet when arriving at our postoperative care unit (PACU). Blood samples will be taken at 0 hour, 1 hour, 2 and 6 hours after administration in order to investigate bioavailability.

Detailed description: After written informed consent, blood samples will be taken before administration, after 1 hour, 2 hours and 6 hours. Need of rescue analgesia (morphine iv) and level of pain, as well as side effects will be registered

Eligibility criteria: Inclusion Criteria: Healthy women \> 18 years old, with one healthy fetus scheduled for a elective caesarean section in spinal anesthesia, read and signed informed consent

-

Exclusion Criteria:

* Known intolerability to oxycodone. Previous use of opioids. Hight \< 150 cm, preconceptual BMI \> 35. ASA \> 2.

Primary outcomes:
measure: level of oxycodone in serum
timeFrame: 1 hour after administration
measure: level of oxycodone in serum
timeFrame: 2 hours after administration
measure: level of oxycodone in serum
timeFrame: 6 hours after administration
Secondary outcomes:
measure: level of pain
timeFrame: 0, 1, 2, and 6 hours after administration
Other outcomes:
measure: Side effects
timeFrame: 1,2 and 6 hourd after administration
Locations:
city: Nordbyhagen
country: Norway
facility: Akershus University Hospital
state: Akershus
Study officials:
affiliation: Head of anesthesia dept
name: Vegard Dahl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05108337: Superficial Cervical Plexus Block for Postoperative Chronic Pain
Official title: Ultrasound Guided Superficial Cervical Plexus Block for Chronic Pain After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurosurgery
Keywords: Cervical Plexus Block
Chronic pain
Neurosurgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of postoperative chronic pain after craniotomy is high. Postoperative chronic pain seriously affects patient's quality of life. Compound local scalp nerve block is a good choice for analgesia after craniotomy. However, the scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach craniotomy, leading to incomplete block. Superficial cervical plexus block (SCPB) is theoretically promising to solve the analgesia requirements of such surgical approach. At the same time, ultrasound guidance can not only accurately locate, ensure the effect of block and avoid accidental injury during puncture. The purpose of this study is to explore whether ultrasound-guided superficial cervical plexus block can safely and effectively reduce the incidence of chronic pain after craniotomy via suboccipital retrosigmoid approach.


Eligibility criteria: Inclusion Criteria:

1. Elective suboccipital retrosigmoid approach approach craniotomy;
2. Age between 18 and 65 years;
3. American Society of Anesthesiologists (ASA) physical status I-III.

Exclusion Criteria:

1. The patients or legal clients refuse to provide informed consent;
2. Local infection;
3. Preoperative impairment of consciousness and cognitive function;
4. Uncontrolled hypertension;
5. Inability to communicate;
6. Allergies to experimental drugs;
7. History of drug abuse;
8. History of chronic headache;
9. Aphasia and hearing impairment;
10. Patients undergoing second craniotomy;
11. Body mass index \< 18.5 kg/m2 or \> 35.0 kg/m2;

Primary outcomes:
measure: Chronic pain assessment
timeFrame: at 3 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00792337: The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma
Official title: The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2008-11-17
Enrollment: 53
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: We hypothesize that simvastatin in combination with ICS might have synergistic anti-inflammatory effects on airway inflammation in asthmatic patients

Detailed description: To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum

Eligibility criteria: Inclusion Criteria:

* He or she has FEV1 \> 60% of predicted
* He or she requires less than 1000 mcg daily of beclomethasone or equivalent

Exclusion Criteria:

* He or she had previous history of renal disease or serum creatinine more than 2 mg/dL
* He or she had previous history of liver disease
* She is pregnant or during lactation
* He or she has already received statins or is allergic to statins or has developed myositis.
* He or she has an asthma exacerbation and requires treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.

Primary outcomes:
measure: Sputum eosinophil
timeFrame: 8 WEEKS
Secondary outcomes:
measure: FEV1
timeFrame: 8 WEEKS
measure: PC20
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Kittipong Maneechotesuwan
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Kittipong - Maneechotesuwan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04282837: Machine Learning for Reclassification of Obesity
Official title: Data-driven Clustering for Metabolic Classification of Obesity Using Machine Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Machine learning
Metabolic classification
Clustering
Bariatric surgery
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: The Third People's Hospital of Chengdu
name: Shanghai East Hospital
name: University of Pittsburgh
First posted: 2020-02-25
Enrollment: 2495
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with overweight/obesity.

Brief summary: The goal of this study is to employ or develop computational modeling techniques for the precise reclassification of obesity into subgroups. Clinical features, risks of noncommunicable diseases, as well as weight loss effects of bariatric surgery will also be studied and compared within the subgroups.


Eligibility criteria: Inclusion Criteria:

1. Patients with overweight/obesity
2. Patients with normal weight as controls

Exclusion Criteria:

1. had ever been performed with a bariatric surgery before the study's first visit is scheduled;
2. had taken exogenous insulin, medication that affects glucose metabolism, or uric acid drugs currently;
3. being diagnosed with type 1 diabetes, secondary diabetes, hereditary disease, or severe disease (e.g. malignant tumor, heart failure, liver failure, etc.);
4. in gestation of lactation;
5. did not have the complete data for model;
6. for normal-weight controls, patients with diabetes or hyperuricemia were excluded.

Primary outcomes:
measure: Metabolic classification of patients with obesity using machine learning
timeFrame: baseline
Secondary outcomes:
measure: Metabolic features in patients of different subgroups
timeFrame: baseline
measure: Risks for noncommunicable disease in patients of different subgroups
timeFrame: baseline
measure: Effect of bariatric surgery in patients of different subgroups
timeFrame: 1 year after bariatric surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References:
citation: Lin Z, Feng W, Liu Y, Ma C, Arefan D, Zhou D, Cheng X, Yu J, Gao L, Du L, You H, Zhu J, Zhu D, Wu S, Qu S. Machine Learning to Identify Metabolic Subtypes of Obesity: A Multi-Center Study. Front Endocrinol (Lausanne). 2021 Jul 14;12:713592. doi: 10.3389/fendo.2021.713592. eCollection 2021.
Clinical trial NCT05815537: Development of Functional Spatial Hearing in Reverberation
Official title: Development of Functional Spatial Hearing in Reverberation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Spatial Hearing Development
Lead sponsor: Father Flanagan's Boys' Home
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two arms in the exposure of reverberation for participants. For children (n1=45) and adults (n1=15) assigned to Arm 1, they receive a non-reverberant environment (control) and a low-reverberant environment (intervention A). For children (n2 = 45) and adults (n2 = 15) assigned to Arm 2, they receive the same non-reverberant environment (control) and a high-reverberant environment (intervention B). Both arms of children and adults enrolled perform the same psychoacoustic tasks for outcome assessments.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the clinical trial study (Phase 0) is to map out the developmental trajectory of functional spatial hearing abilities in reverberant environments for children with normal hearing between the ages of 6 and 18 years, and to understand the inter-relationships between the three perceptual abilities: auditory object size formation, spatial acuity, and spatial unmasking during typical development. Children are asked to perform psychoacoustic tasks when the auditory stimuli are processed to present in virtual acoustic environments (1) with no reverberation and (2) with one of the two levels of reverberation that emulate everyday indoor environments. The intervention of this clinical study is in the random assignment of one of the two reverberant environments. Researchers will compare these children with a group of normal-hearing adults to anchor matured performances.


Eligibility criteria: Inclusion Criteria:

* All individuals within age limits who are typically developing with normal hearing who pass 25 dB HL from 250 Hz to 8000 Hz.

Exclusion Criteria:

* Individuals who fail hearing screen as described above.
* Individuals who have a diagnosed intellectual developmental disability

Primary outcomes:
measure: Auditory Object Size (Apparent Source Width)
timeFrame: Year 1-3
measure: Spatial Acuity (Minimum audible angle)
timeFrame: Year 1-3
measure: Spatial Unmasking (Minimum angular separation)
timeFrame: Year 1-3
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Boys Town National Research Hospital
state: Nebraska
Study officials:
affiliation: Father Flanagan's Boys' Home
name: Z. Ellen Peng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03536637: DMT310-001 Topical in the Treatment of Acne Vulgaris
Official title: A Study of Tolerability, Safety, And Efficacy, of DMT310 In Patients With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Dermata Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-05-25
Enrollment: 121
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Patient is male or non-pregnant female at least 18 years of age.
* Clinical diagnosis of moderate to severe acne vulgaris as determined by:

Investigator's Global Assessment (IGA) at Randomization Patient has at least 20 but not more than 50 inflammatory lesions on the face Patient has at least 20 but not more than 100 noninflammatory lesions on the face

* Patient is willing to apply the Investigational Product as directed
* Patient is willing and able to comply with the protocol

Exclusion Criteria:

* Patient is pregnant or planning to become pregnant
* Patient is taking a topical therapy on the face which may affect the patient's acne

Primary outcomes:
measure: Efficacy as measured by lesion counts
timeFrame: 12 weeks
measure: Efficacy as measured by Investigator Global Assessment (IGA)
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of adverse events as a measure of safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Dermata Investigational Site
state: California
city: Saint Joseph
country: United States
facility: Dermata Investigational Site
state: Missouri
city: Henderson
country: United States
facility: Dermata Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: Dermata Investigational Site
state: New Mexico
city: High Point
country: United States
facility: Dermata Investigational Site
state: North Carolina
city: Tennessee
country: United States
facility: Dermata Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Dermata Investigational Site
state: Texas
city: College Station
country: United States
facility: Dermata Investigational Site
state: Texas
city: Katy
country: United States
facility: Dermata Investigational Site
state: Texas
Study officials:
References:
Clinical trial NCT01040637: A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
Official title: A Phase 1/Phase 2, Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Effect on Opioid Analgesia of TD-1211 Administered Orally to Healthy Volunteers and to Assess the Safety, Pharmacokinetics, and Effect on Bowel Movements in Subjects With Opioid-Induced Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Opioid-induced Constipation
Keywords: Healthy subjects
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2009-12-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).


Eligibility criteria: Inclusion Criteria:

* Males and females between 18 and 65 years of age, inclusive
* Healthy subjects and subjects with documented OIC on stable opioid regimen
* Willingness to stop all laxatives throughout the OIC screening and treatment period

Exclusion Criteria:

* Any clinically significant finding in healthy subjects
* Have participated in another clinical trial of an investigational drug 30 days prior to screening
* History of chronic constipation prior to opioid therapy in OIC subjects
* Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects

Primary outcomes:
measure: Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation
timeFrame: Daily pre and post dose assessments throughout the duration of the study period
Secondary outcomes:
measure: Evaluation of the multiple dose pharmacokinetics of TD-1211 following oral administration
timeFrame: Daily pre and post dose assessments throughout the duration of the study period
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Clinical Research Unit
state: California
city: San Antonio
country: United States
facility: Clinical Research Unit
state: Texas
city: Salt Lake City
country: United States
facility: Clinical Research Unit
state: Utah
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03055637: Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
Official title: Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fistula of Soft Palate (Disorder)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 32
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus two-flap palatoplasty for cleft palate repair.

Detailed description: Up to 6 hours before the scheduled arrival time, formula-fed babies may be given formula. Up to 4 hours before the scheduled arrival time, breastfed babies may nurse. Up to 2 hours before the scheduled arrival time, give only clear liquids. Clear liquids include water, Pedialyte®, Kool-Aid® and juices you can see through, such as apple or white grape juice. In the 2 hours before the scheduled arrival time, give nothing to eat or drink. Induction of general anaesthesia will be administered followed by local anaethesia. Then, Surgical prodecure will be done either following the conventional two flap palatoplasty technique or the Furlow double-opposing z-plasty technique.

Eligibility criteria: Inclusion Criteria:

1. Age of Repair from 9 to 12 months.
2. Isolated Cleft Palate
3. Operation time should nearly be the same for all patients
4. Surgical skills done by same surgeon
5. Both sexes

Exclusion Criteria:

1. Patients with hypoplasia of palatal tissue.
2. Patients with associated anomalies.
3. Patients with associated syndromes.
4. Other types of cleft palate.

Primary outcomes:
measure: Incidence of fistula
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05123937: Effects of Bobath Technique Versus Task Oriented Training on Gross Motor Function in Cerebral Palsy Children
Official title: Effects of Bobath Technique Versus Task Oriented Training on Gross Motor Function in Cerebral Palsy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral palsy is the most familiar motor disorder of childhood. Consistent with the results of recent scientific researches BOBATH approach in physical restoration of youngsters with cerebral palsy promotes formation of motor skills. Improvement in mobility has been primary goal in treatment of CP. There are only a few studies available within the efficacy of "task-oriented training" to improve gross motor function in CP child. Hence, this comparative study is undertaken to gauge the effect of task-oriented training verses neurodevelopmental training on gross motor function in cerebral palsy child. Objective of this study is to find out the effects of BOBATH technique and Task Training on gross motor function in cerebral palsy children. A Convenient sample of Cerebral Palsy children fulfilling inclusion and exclusion criteria, from physiotherapy OPD of Allied \& DHQ hospitals of Faisalabad will be considered. Informed consent will be taken from all patient's caregivers. Patients will be divided into two groups through chit draw randomization. Age of children will be 3 years to 10 years without discrimination of gender. Group A will receive BOBATH training and Group B will receive task training. Data will be collected through Gross Motor Function Measure (GMFM-88). Data analyses using SPSS version 25 as a statistical tool.


Eligibility criteria: Inclusion Criteria:

Male and female patient Age 3- 10 years. Diagnosed with CP by a specialist. Children with CP GMFCS level I-II. Types of Cerebral palsy (spastic diplegic, quadriplegic, hemiplegic,) without severe abnormalities Cognitive ability should be sufficient that he/she follow simple verbal commands and instructions during training

Exclusion Criteria:

Patient with fixed contracture Patient receiving treatment that affects motor function such as botulinum injection and orthopedic surgery

-

Primary outcomes:
measure: Gross Motor Function Measure (GMFM-88)
timeFrame: Base line and after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Allied Hospital Faisalabad
state: Pakistan(Punjab_
Study officials:
affiliation: Riphah International University
name: Tehreem Mukhtar, MS
role: PRINCIPAL_INVESTIGATOR
References: