louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04713696: Core Stability for Baseball Batting in Adolescents
Official title: Using Functional Movement Patterns to Investigate the Impact of Core Stability on Hitting Mechanics and Bat Swing Velocity in High School Baseball Players
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Athletes
Adolescent
Keywords: Batting mechanics
Bat-swing velocity
Baseball
Lumbopelvic control
Exercise
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Baseball batting is important to winning the games. Baseball batting is achieved by proximal-to-distal sequencing of body movements and controlled by the neuromuscular system. Poor lumbopelvic control could influence production and transfer of energy in the kinetic chain. This study aims to investigate the effects of functional movement training on hitting mechanics and bat swing velocity in high school baseball players.


Eligibility criteria: Inclusion Criteria:

* Sport specialization in baseball batting
* Active players on baseball teams

Exclusion Criteria:

* History of surgery in the lumbar area
* Severe musculoskeletal or neurological symptoms that interfere with participation in competition, training or tests

Primary outcomes:
measure: Bat-swing velocity
timeFrame: Changes from baseline to 8 weeks post intervention
measure: Batting movement
timeFrame: Changes from baseline to 8 weeks post intervention
Secondary outcomes:
measure: Dynamic balance
timeFrame: Changes from baseline to 8 weeks post intervention
measure: Functional performance
timeFrame: Changes from baseline to 8 weeks post intervention
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University
name: Yi-Liang Kuo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03347916: Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation
Official title: The Role of Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation and Delirium in Children After Strabismus Surgery: A Prospective Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emergence Agitation After Desflurane Anesthesia
Lead sponsor: Kuwait Specialized Eye Center
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 75
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to study the effect of oral gabapentin (5 mg/kg) on emergence agitation after desflurane anesthesia in pediatrics undergoing starbismus surgery


Eligibility criteria: Inclusion Criteria:

* pediatric patients (2-6 years old), with an American society of Anesthegiologists physical status (ASA) I-II who were undergoing strabismus surgery (for more than one muscle)

Exclusion Criteria:

* failure to obtain consent, mental retardation or developmental delay, epilepsy, psychiatric or neurological diseases that impair communication, current use of gabapentin, psychotropic or opioids.

Primary outcomes:
measure: emergence agitation incidence and scores
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: duration of emergence
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Kuwait Specialized Eye Center
Study officials:
References:
citation: Badawy AA, Kasem SA, Rashwan D, Al Menesy T, Adel G, Mokhtar AM, Badawy YA. The role of Gabapentin oral solution in decreasing desflurane associated emergence agitation and delirium in children after stabismus surgery, a prospective randomized double-blind study. BMC Anesthesiol. 2018 Jun 20;18(1):73. doi: 10.1186/s12871-018-0533-5.
Clinical trial NCT02271516: to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage
Official title: A Phase I, Open-label, Dose-escalation Study to Determine the Maximum Tolerance Dose (MTD) and to Evaluate the Safety of 188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tumors
Lead sponsor: National Atomic Research Institute, Taiwan
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to determine the maximum tolerance dose (MTD) and to evaluate the safety of 188Re-BMEDA-liposome in patient with primary solid tumor in advanced or metastatic stage.

Detailed description: Rhenium-188 is an ideal radionuclide for therapeutic use due to its maximum beta emission of 2.12MeV, short physical half-life of 16.9 hours, and its 155-keV gamma emission for imaging purposes. 188Re-BMEDA-liposome consists of 2 separate components (Rhenium-188 and liposome) and BMEDA as a linker. This study aims to find the MTD, evaluate the safety, efficacy profiles and investigate the biodistribution, radioactivity and radiation dosimetry of 188Re-BMEDA-liposome on primary solid tumor in metastatic stage patient by a single intravenous injection course.

Eligibility criteria: Inclusion Criteria:

* Patient with histologically confirmed diagnosis of primary solid tumor, and with pathologically or radiologically documented metastases
* Disease that is measurable or evaluable by RECIST 1.1 criteria (for Solid Tumors)
* Patient with metastatic cancer that are refractory to current standard/available therapies

Exclusion Criteria:

* brain metastases
* serious concurrent infection or nonmalignant illness that is uncontrolled
* uncontrolled intercurrent illness
* Immunocompromised
* significant traumatic injury within 3 weeks before Day 0
* History of hypersensitivity to any component of study drug

Primary outcomes:
measure: Determine the MTD
timeFrame: up to 30 days per cohort
Secondary outcomes:
measure: change in vital signs and pysical examination
timeFrame: from day 0 to up t0 60 days per cohort
measure: change in lab data
timeFrame: from day 0 to up t0 60 days per cohort
measure: Adverse event(s)
timeFrame: from day 0 to up t0 60 days per cohort
measure: Serious Adverse event(s)
timeFrame: from day 0 to up t0 60 days per cohort
measure: Change in EKG
timeFrame: in 24hrs
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital (Taiwain)
Study officials:
affiliation: Taipei Veterans General Hospital (Taiwain)
name: Shyh-Jen Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05518916: Effects of Yakson Method and Swaddling on Pain and Physiological Parameters
Official title: Effects of Yakson Method Applied by Mother and Swaddling on Pain and Physiological Parameters During Heel Stick in Newborn
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain During Heal Lancing
Keywords: nonfarmacology
pain
heal lancing
Yakson Method
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 48
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, three-arm randomized controlled clinical trial
Primary purpose: OTHER

Brief summary: Type of Study: The study was planned to be conducted in a randomized controlled experimental design.

Place and Time of the Research: Institutional permission will be obtained from the Balcalı Training and Research Hospital in Adana for the collection of research data. Researchers commit to start data collection after obtaining institutional permission. The data collection process will take 1 year after obtaining the institutional permission.

48 newborns who are suited the inclusion criteria will be included in the study. Participants will be assigned to 3 groups according to randomization: Swaddling, Yakson Method, and Control.

Detailed description: Total processing time and baby's crying time are calculated by watching video recordings. In order to find the total procedure time, starting from the puncture of the baby's heel, the time until the dry cotton is placed on the baby's heel after the blood collection process is completed is calculated. The heart rate and SpO2 are noted by the investigator during the heel lancing procedure. Pain assessment of infants is done by two independent neonatal nurses, apart from the researcher, by watching video recordings. The scores given by the two observers will be evaluated by making inter-observer harmony. Before the evaluation, the nurses will be trained about the scale and its evaluation.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria for Newborn:

* Born at term (38-42 weeks)
* Healthy newborn
* Absence of congenital anomaly
* No analgesic or sedative medication has been administered in the last 6 hours
* Parent's consent for inclusion in the study in accordance with the consent form

Inclusion Criteria for Mother:

* Mother's willingness to participate in the study
* The mother can be mobilized and not have a physical disability (so that she can appyl Yakson therapy for her baby)
* Being communicative

Exclusion Criteria:

* Babies whose blood cannot be drawn on the first try

Primary outcomes:
measure: Neonatal Infant Pain Scale (NIPS):
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01221116: Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
Official title: Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Cardiac Surgery
Keywords: coronary artery disease,
aortic stenosis,
heart failure
Lead sponsor: Ullevaal University Hospital
Sponsor class: OTHER
First posted: 2010-10-14
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit

Detailed description: Single center, prospective, randomized parallel-group, double-blinded study

Eligibility criteria: Inclusion Criteria:

* EF (ejection fraction)\<40%

Exclusion Criteria:

* renal failure, liver failure

Primary outcomes:
measure: Need for inotropic agents or IABP (intra aortal balloon pump)
timeFrame: jan 2003 - dec 2008
Secondary outcomes:
measure: Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data.
timeFrame: jan 2003-dec 2008
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Knut A Kirkebøen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01725516: Effect of Myofascial Release Technique on Reducing Symptoms in Patients With Chronic Disc Protrusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-11-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT

Brief summary: The purpose of this study is to determine whether myofascial release technique are effective in the treatment of low back pain due to lumbar disc herniation.


Eligibility criteria: Inclusion Criteria:

* lumbar disc herniation
* Muscular trriger points
* independent ambulated patients

Exclusion Criteria:

* Neoplasm
* Lumbar surgery history
* fracture
* inflammatory disease

Primary outcomes:
measure: Pain
Secondary outcomes:
measure: Oswestry Disability Index
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01786616: Polymorphism of beta2-adrenoceptor and Regular Use of Formoterol in Asthma
Official title: Polymorphism of beta2-adrenoceptor and Regular Use of Formoterol in Asthma: Preliminary Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Catholic University, Italy
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pneumological outpatient clinic

Brief summary: Polymorphism at codon 16 of the beta2-adrenoceptor (beta2-AR) affects the responsiveness to salmeterol in asthmatics. Data concerning formoterol are more controversial in literature. The aim of this study was to verify whether homozygote for arginine-16 (ArgArg16) and homozygote for glycine-16 (GlyGly16) genotypes differently influence the long-term responsiveness to formoterol.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate asthma
* Stable clinical conditions

Exclusion Criteria:

* Smokers
* Current therapy with oral steroids
* Exacerbations within the past 3 months

Primary outcomes:
measure: Peak Expiratory Flow (PEF) variability
timeFrame: PEF has been monitorized during the 4-week treatment period
Secondary outcomes:
measure: Forced Expiratory Volume in 1 sec (FEV1) slope of the dose-response curve to salbutamol
timeFrame: At the end of the 4-week treatment period
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University, Pneumology Unit
Study officials:
References:
Clinical trial NCT03938116: Healing Hearts Together: Evaluating a Couples-based Intervention to Improve Health Outcomes
Official title: Healing Hearts Together: Evaluating a Couples-based Intervention to Improve Health Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: couple relationship
heart disease
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 608
Sex: ALL
Minimum age (years): 18
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 test the efficacy of the 8-week Healing Hearts Together (HHT) program to improve relationship quality, mental health, quality of life (QoL), and cardiovascular health. This is a randomized controlled trial in which couples are randomly assigned to the HHT group or usual care. Changes in the outcomes of interest will be assessed at the end of the intervention (8 weeks) and 6 months later.


Eligibility criteria: Inclusion Criteria:

1. University of Ottawa Heart Institute (UOHI) patients and their partners
2. Participants in a romantic relationship who are cohabiting (married, common-law or committed relationship for ≥1 year). No restrictions will be placed on sexual orientation.
3. Participants are ≥ 18 years of age
4. Participants are able to read and understand English (HHT materials are only available in English; once efficacy has been established, all materials will be translated to French).
5. Patients and partners are available to participate for the next 6 months (intervention and follow-up).
6. Patients and partners are able to provide informed consent.

Exclusion Criteria:

1. Participants who, in the opinion of the study psychologist, manifest psychiatric illness or cognitive impairment that would preclude participation in HHT (i.e. unable to benefit from the intervention; to prevent disruption of other participants).
2. Participants who are engaging in couples therapy or plan to engage in couples therapy in the next 6 months.

Primary outcomes:
measure: Relationship quality: DAS
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
References:
Clinical trial NCT04096716: Mapping Draining Lymph Nodes in CNS Malignancies
Official title: Mapping Draining Lymph Nodes in CNS Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Central Nervous System Neoplasms
Central Nervous System Tumor
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Lloyd J. Old STAR Program
First posted: 2019-09-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to determine whether the lymph nodes that drain a brain tumor can be detected by imaging after injection of a substance called Tc-99m tilmanocept directly into the brain tissue around the tumor. Tc-99m tilmanocept is a radioactive substance that is used to find lymph nodes by injecting it and then scanning the body with a device that can trace its radioactivity. In this study, the investigators are looking to see how long it takes the Tc-99m tilmanocept to travel from the tumor to the lymph nodes. The investigators will be using it to map lymph nodes as they relate to specific brain areas.


Eligibility criteria: Inclusion Criteria:

* Candidate for surgical resection or stereotactic biopsy of suspected brain tumor, including benign tumors (e.g., meningioma) and malignant tumors (e.g., glioma or metastatic disease).
* Suitable candidate to receive Tc-99m tilmanocept injection and study related imaging post-operatively per the Principal Investigator and/or treating neurosurgeon.
* At least 18 years of age.
* Willing and able to provide informed consent (or consent of legally authorized representative).

Exclusion Criteria:

* Documented hypersensitivity to dextran and/or modified forms of dextran.
* Pregnant.
* Prior surgical evacuation of lymph nodes of the head and/or neck

Primary outcomes:
measure: Time course of Tc-99m tilmanocept drainage to the lymph nodes from the brain (Cohort 1 only)
timeFrame: Up to Day 2
measure: Identify and map lymph nodes from distinct brain regions as measured by the 2013 international consensus guidelines for cervical and cranial lymph nodes
timeFrame: Up to Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tanner Johanns, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03891316: Sevoflurane Human Biomonitoring in Operating Room Personnel
Official title: Human Biomonitoring of Operating Room Personnel With Occupational Exposure to the Volatile Anaesthetic Sevoflurane
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Occupational Exposure
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicans with or without occupational exposure to sevoflurane.

Brief summary: Sevoflurane is a widely used volatile agent for induction and maintenance of anaesthesia. The administration of sevoflurane involves the risk of occupational exposure. Possible negative implications of chronic occupational exposure to sevoflurane are not completely refuted. In Germany no maximum workplace concentration for sevoflurane is defined. This study aims to find out if working conditions of physicians and different anaesthesia techniques effect the extent of occupational exposure to sevoflurane.

Detailed description: In this prospective observational trial 7 cohorts of 4 participants each are investigated. The cohorts consist of physicians working at different places in the operating theatre with different occupational exposure to sevoflurane, and one cohort not working in the operating theatre at all. In order to determine the extent of occupational exposure to sevoflurane a human biomonitoring is conducted. Urinary Sevoflurane and its metabolite hexafluoroisopropanol (HFIP) are measured after 3 consecutive working days.

UPDATE: After detecting traces of HFIP in all cohorts even in physicians not working in the operating theatre measurements were repeated, more cohorts were added including a negative control and measurements before the study period of 3 consecutive working days were added.

UPDATE: For comparison one cohort of patients having undergone sevoflurane anaesthesia was added.

Eligibility criteria: Inclusion Criteria:

* Occupational exposure to sevoflurane while conducting sevoflurane anaesthesia/being present during sevoflurane anaesthesia
* Possible occupational exposure to sevoflurane while working in the operating room/perioperative anaesthesia care unit
* No occupational exposure to sevoflurane (working outside the operating theatre)

Exclusion Criteria:

* Presence during a mask induction with sevoflurane

Primary outcomes:
measure: Urinary HFIP concentration (µg/l)
timeFrame: After 3 consecutive days of work
measure: Urinary sevoflurane concentration (µg/l)
timeFrame: After 3 consecutive days of work
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Katharina Roeher, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: