louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03054012: Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mandibular Injuries
Keywords: CAD-CAM software
accuracy
head and neck region
mandibular reconstruction
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included

Brief summary: Background:

Functional and aesthetic reconstruction of mandibular defects due to tumour invasion, osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good anatomic and symmetric reconstruction with stable occlusion and condylar position. Classically this was obtained by (pre)bending a reconstruction plate, and providing osteotomies at the vascularized free flap. Today there is the availability of CAD-CAM software enabling a preoperative planning based on 3D models. This computer-assisted surgery (CAS) procedure is said to improve accuracy of the postoperative result, as well as a reduce ischemia time. However, there is a need for objective analysis of the accuracy of CAS, as well as the effective reduction in operating time and financial implication.

Study design:

Retrospective study.

All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included. Accuracy will be measured between the planned and actual result, through segmentation of the mandible in Brainlab software. Parameters regarding ischemic time and financial cost will be obtained from the medical files.


Eligibility criteria: Inclusion Criteria:

* patients of all ages
* patients of both genders
* patients requiring mandibular reconstruction due to tumour invasion, osteoradionecrosis, osteochemonecrosis or trauma
* all patients undergoing bony reconstruction by free vascularised flap
* all patients treated between January 2013 and August 2016
* all patients where CAS was applied

Exclusion Criteria:

* all patients not eligible according to abovementioned criteria

Primary outcomes:
measure: accuracy of planned and actual result, through segmentation of mandibles Brainlab software
timeFrame: 6 months postoperative
Secondary outcomes:
measure: ischemia time
timeFrame: perioperative
measure: financial implication
timeFrame: preoperative
Other outcomes:
Locations:
Study officials:
affiliation: Head of department
name: Johan Abeloos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03841812: Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol
Official title: Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol Using Index of Nociception (NOX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nociceptive Pain
Analgesic Adverse Reaction
Inhalant Use
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study purpose to compare analgesia efficiency of propofol combine with sevoflurane with propofol only using index of Nociception (NOX)

Detailed description: 1. Recently study found sevoflurane plays an important role through spinal nerve peptide receptor (NK.1R), glycine receptor (GlyR), neuron nicotinic receptor (nnAChRs), Methyl-1-methyl-1-day aspartate (NMDA receptor), and TRPV1 receptor (TRPV1 receptor) produce the analgesic efficiency.
2. propofol was traditional sedation reagent.
3. index of Nociception (NOX) was the objective index for analgesia This study purpose to compare analgesia efficiency of Only Propofol and sevoflurane combine with propofol using index of Nociception (NOX)

Eligibility criteria: Inclusion Criteria:

* Participants were aged 18-65 years old,
* American Society of Anesthesiologists (ASA) physical status I, II or III
* scheduled to have urological surgery(would last longer than 1 h)
* requiring general anesthesia.

Exclusion criteria:

* refused to participate in this study;
* Unable to communicate normally because of consciousness alterations;
* a history of allergy to opioids
* contraindications to inhalational anesthesia
* a family history of malignant hyperthermia
* a history of alcohol or drug abuse
* received central nervous system-active drugs
* super obese as defined by a body mass index ≥40 kg/m2
* conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors of the intravenous and inhalation anesthetics
* previous head injury
* neurologic
* psychiatric disease
* any disabling central nervous
* cerebrovascular disease
* using psychoactive
* anti-convulsive medications at the time
* unstable angina
* manifested congestive heart failure
* expected difficulty airway management

Primary outcomes:
measure: qNOX change
timeFrame: during operation
Secondary outcomes:
measure: PACU duration
timeFrame: 24 hours
measure: PONV difference between two groups
timeFrame: 24 hours
measure: Post- operative pain difference between two groups
timeFrame: 24 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Ke Huang, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03930212: Progesterone Supplementation in Threatened Abortion
Official title: Progesterone Supplementation in Threatened Abortion: Is it a Sound Practice?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Threatened Abortion
Progesterone Resistance
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 190
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To decide whether progesterone supplementation in threatened abortion is a sound practice.

Detailed description: This study was conducted at Obstetrics and Gynecology Department, Tanta University in the period from January 2018 to December 2018. Patients: Eligible patients (n=190) were randomly allocated into 2 groups; study group who will receive progesterone supplementation (Prog.group) and control group who will receive no treatment (place.group).

Eligibility criteria: Inclusion Criteria:

* threatened abortion diagnosed by history and ultrasound examination
* singleton
* viable fetus
* gestational age \< 20 weeks
* closed normal length cervix.

Exclusion Criteria:

* short cervix \<2 cm Multiple pregnancy
* dead fetus
* open cervix ≥ 2cm
* history of cervical surgery
* refusal to participate.

Primary outcomes:
measure: relief of pain
timeFrame: 3 weeks
measure: completion of pregnancy beyond 20 weeks
timeFrame: 12 weeks
measure: Stoppage of bleeding
timeFrame: 3 weeks
Secondary outcomes:
measure: abortion less than 20 weeks.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
Study officials:
References:
Clinical trial NCT00314912: Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease
Official title: An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2006-04-17
Enrollment: 650
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase III open-label extension study is to evaluate the long-term safety of Tramiprosate (3APS) in patients with mild to moderate Alzheimer's disease.

Detailed description: Duration of treatment: 12 months. Patients who complete the Phase III clinical trial will be offered the opportunity to receive Tramiprosate (3APS) in an open-label extension study

Eligibility criteria: Inclusion Criteria:

* The patient must have successfully completed the full 78-week duration of the double-blind CL-758007 study.
* Male or female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
* Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
* The patient must be presenting a reasonably good nutritional status.
* Signed inform consent from the patient or legal representative.

Exclusion Criteria:

Patients will not be eligible to participate in the study if they meet any of the following criteria:

* The patient participates in another drug trial during the study.
* The patient with a clinically significant and/or uncontrolled condition or other significant medical disease.
* The patient is unable to swallow medication tablets.

Primary outcomes:
measure: To evaluate the long-term safety of Tramiprosate (3APS).
Secondary outcomes:
measure: To provide additional long-term data on the efficacy of Tramiprosate (3APS).
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
Study officials:
References:
Clinical trial NCT06695312: High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy
Official title: Effect of High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Radiculopathy
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 42
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the Effect of High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy Patients.

Detailed description: Forty two patients with Cervical Radiculopathy will participate in this study. The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to High Tone Power Therapy, three times per week for four weeks. The evaluation methods are cervical joint position error test, neck disability index, Cervical range of motion (CROM) and visual analogue scale

Eligibility criteria: Inclusion Criteria:

* Their ages range from 35 to 50 years.
* Both sex
* With mild to moderate cervical disability according to the neck disability index
* Unilateral cervical radiculopathy for more than 6 months.
* Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI).
* Normal body mass index (18.5 - 24.99Kg/m2).

Exclusion Criteria:

* Any other musculoskeletal disorders of the spine or upper extremity
* Patients with any other Neurological deficits, psychiatric disease Cervical myelopathy, Cognitive problems, vertebral fractures and previous history of spine or cervical surgery.
* Neck pain with vertigo or with bilateral upper limbs referred pain.
* Clinical instability, recent trauma and vertebrobasilar insufficiency.
* Structural abnormalities of the spine, osteoporosis, and spasmodic torticollis.
* Inflammatory or other specific disorders of spina such as ankylosing spondylitis and rheumatoid arthritis

Primary outcomes:
measure: cervical joint position error test
timeFrame: four weeks
measure: Neck disability index
timeFrame: four weeks
measure: CROM
timeFrame: four weeks
Secondary outcomes:
measure: Visual analogue scale for pain (VAS-P)
timeFrame: four weeks
Other outcomes:
Locations:
city: Al Jīzah
country: Egypt
facility: October 6 university
state: Giza
Study officials:
References:
Clinical trial NCT02140112: Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo in Autism Spectrum Disorder
Official title: A RANDOMIZED, DOUBLE-BLIND, PHASE 2A CROSSOVER STUDY TO ASSESS THE SAFETY AND EFFICACY OF TRICHURIS SUIS OVA FOR THE TREATMENT OF AUTISM SPECTRUM DISORDER
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Autism
Keywords: T. suis ova
Trichuris suis ova
Autism Spectrum Disorder
ASD
Lead sponsor: Coronado Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-16
Enrollment: 23
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric patients with autism spectrum disorder with all patients receiving 16-weeks of TSO treatment and 16 weeks of placebo.


Eligibility criteria: Inclusion Criteria:

* Male or female patients, 5 to 17 years of age
* Patients must fulfill DSM-V diagnostic criteria for autism spectrum disorder ascertained at screening, using a clinical review confirmed by the Autism Diagnosis Observation Schedule - Second edition (ADOS-2)
* Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support patients' adherence to the study procedures must be obtained for patients who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the patient will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
* Patients are able and willing to swallow study medication suspension.

Exclusion Criteria:

* Known diagnosis of syndromal form of Autism (e.g. Rett Syndrome, Childhood Disintegrative Disorder, Fragile X Syndrome, etc.)
* Patients who cannot discontinue anti-psychotic medication
* Patients with current active seizure disorder or who have had a seizure within the last 6 months prior to screening
* Female patient who is pregnant or breastfeeding or wishing to become pregnant during study participation or unwilling to use birth control.
* Patients who have received helminthic treatment

Primary outcomes:
measure: Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks
timeFrame: 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research & Resource Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
city: Naperville
country: United States
facility: Baber Research Group
state: Illinois
city: Bronx
country: United States
facility: Montefiore Medical Center Dept. of Psychiatry, Child Annex
state: New York
city: Houston
country: United States
facility: Red Oak Psychiatry
state: Texas
Study officials:
References:
Clinical trial NCT00815412: ACTIVATE: Standard Worksite Health Program vs. Activated Consumer
Official title: ACTIVATE: Standard Worksite Health Program vs. Activated Consumer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evidence of Improved Health Status
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2008-12-30
Enrollment: 631
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A 3-year, randomized, controlled trial comparing a traditional worksite health promotion program and an activated consumer program on health practices, health status and patient activation measures.

Detailed description: The design is a cluster, randomized controlled trial of two companies with three arms in each company. The arms include two control groups (one from each company), two intervention groups using a standard health promotion intervention, and two intervention groups that constitute using an activated consumer intervention. The standard intervention includes educational offerings to address health behaviors. The activated consumer intervention offers shorter education sessions and includes decision tools and skills development for working with heath care providers to better manage health and clinical conditions. Variables include health risk assessments, clinical measures such as lipids, blood pressure, body mass index, and tobacco use, perception of health care consumer practices, claims costs, and absenteeism analysis.

Eligibility criteria: Inclusion Criteria:

* Airline and health care employees

Exclusion Criteria:

* Minors

Primary outcomes:
measure: Develop and evaluate a worksite-based, activated consumer intervention
timeFrame: March 2005; March 2007
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01972412: Telephone Use for Care of Persons With Diabetes Mellitus.
Official title: Telephone Support for Self-monitoring of Persons With Diabetes Mellitus Using the Chronic Care Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: nursing care
diabetes mellitus
phone support
chronic care model
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether phone use contributes to diabetes control.

Detailed description: Studies reinforce the need to test innovative care that can serve more patients, since education is a key element for the accession to the treatment of diabetes. Recently, an innovative, feasible and low cost presented in the literature is the use of telephone support as an intervention strategy This study aims to evaluate the implementation of a telephone support for self-monitoring of people with diabetes mellitus treated in ribeirão Preto.

Eligibility criteria: Inclusion Criteria:

* diabetes mellitus type 2
* age
* ability to listen and answer questions

Exclusion Criteria:

* often present less than 75% participation in the proposed activities

Primary outcomes:
measure: Telephone Support for self-monitoring of persons with diabetes mellitus using the Chronic Care Model
timeFrame: Four months
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of São Paulo at Ribeirão Preto College of Nursing
state: São Paulo
city: Ribeirão Preto
country: Brazil
facility: Universidade de São Paulo
state: São Paulo
Study officials:
affiliation: University of São Paulo at Ribeirão Preto College of Nursing
name: Tânia A Canata Becker, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Becker TAC, Teixeira CRS, Zanetti ML, Pace AE, Almeida FA, Torquato MTDCG. Effects of supportive telephone counseling in the metabolic control of elderly people with diabetes mellitus. Rev Bras Enferm. 2017 Jul-Aug;70(4):704-710. doi: 10.1590/0034-7167-2017-0089. English, Portuguese.
Clinical trial NCT06655012: Salmeterol Effect on Exercise Performance
Official title: The Muscle Anabolic Response to β2-adrenergic Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Beta2-adrenergic stimulation
Skeletal muscle hypertrophy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the project is to investigate the muscle anabolic response to acute beta2-adrenergic stimulation in young healthy men and women.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:
* Age 18-40
* Physically active \>5 hours a week
* Maximum oxygen uptake classified as high or very high

Exclusion Criteria:

* Active smoker currently or within the past 5 years
* Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
* Chronic or acute illness deemed by the responsible study physician to affect the test parameters
* Deviation from the study protocol
* Lean mass index \>21 kg/m²
* Pregnancy
* Smoker
* Blood donation during the past 3 months

Primary outcomes:
measure: Power output during sprint testing
timeFrame: Through study completion, an average on 2 weeks
Secondary outcomes:
measure: Power output during time trial
timeFrame: Through study completion, an average on 2 weeks
Other outcomes:
measure: Quadriceps strength
timeFrame: Through study completion, an average on 2 weeks
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References:
Clinical trial NCT03762512: Collection of Placenta for Mitochondria Isolation
Official title: Collection of Placenta for Mitochondria Isolation for Use in Mitochondrial Augmentation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Lead sponsor: Minovia Therapeutics Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant females giving term birth by C-section

Brief summary: Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will be used in mitochondrial augmentation therapy.


Eligibility criteria: Inclusion Criteria:

* Healthy females, singleton pregnancy
* Planned elective C-section
* uncomplicated pregnancy

Exclusion Criteria:

* Donor positive for viruses tested
* Donor excessive smoker or drinker
* Donor known to carry mitochondrial disease

Primary outcomes:
measure: Placenta donated
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center Hospital- Tel Hashomer
Study officials:
References: