louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01777633: Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children
Official title: Palliative Re-irradiation for Progressive Diffuse Intrinsic Pontine Glioma (DIPG) in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pediatric Malignant Brain Tumor -Diffuse Intrinsic Pontine Glioma
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although DIPG is not curable, re-irradiation with a modest total dose and short treatment time provides good palliation of symptoms, improves quality of life, delays disease progression and has minimal and manageable toxicity.

Treatment plan:

At progression, full radiological and clinical documentation necessary including a neurological exam by a neurologist will be done. Progressive patients will be referred to radiotherapy.

Radiation guidelines:

30.6 Gray (Gy) will be applied in 1.8 to 2Gy fractions in conformal radiation to tumor bed. Radiation will be done in standard accelerators and according to standard guidelines used in treatment for all brain tumor patients.


Eligibility criteria: Inclusion Criteria:

1. Age:1 year-22 years
2. Patient/parent consent
3. Diagnosis of DIPG based on short classic history, clinical signs (long tract signs, cranial nerve deficits and ataxia) and classic MRI features (more than 2/3 of the tumor is located within the pons and tumor encompasses more than 60% of the pons)
4. A patient will be eligible for reirradiation if progression is diagnosed following a period of at least 4 months of stable disease after first irradiation.
5. Progression may be either clinical (new neurological deficit or worsening of an old deficit in two separate physical examinations) or radiological (tumor growth of \>25%)

Exclusion Criteria:

1. Radiation necrosis post first irradiation
2. Unstable vital signs
3. Less than X months since previous irradiation

Primary outcomes:
measure: delaying disease progression
timeFrame: 1 year
Secondary outcomes:
measure: improving symptoms
timeFrame: 1 year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT03394833: Hemodynamic Stability During Induction of Anaesthesia
Official title: Hemodynamic Stability During an Induction of Anaesthesia: A Randomized, Non-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Fluid Therapy
Anesthesia; Adverse Effect
Keywords: preoperative
fluid therapy
hemodynamics
anesthesia induction
rapid sequence induction
TCI
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Non-blinded randomization. Standardized method comparison.
Primary purpose: OTHER

Brief summary: The study aim is to investigate if preoperative volume bolus based on lean body weight could preserve mean arterial pressure during target controlled infusion of anaesthesia (TCI) or rapid sequence induction of anaesthesia (RSI) in non-cardiac, non-morbidly obese surgery.

Detailed description: 40 individuals are enrolled to TCI and RSI groups respectively. The randomization process for preoperative fluid bolus prior to induction of anaesthesia is conducted in respective group at the day of surgery. Preoperative colloid fluid therapy (6 ml/kg LBW, Gelofusine™, Fresenius Kabi Ab, Sweden) is infused rapidly before non-invasive baseline blood pressure (NIBP) measurements in twenty individuals in each group. No other intravenous fluids before induction of anaesthesia.

NIBPs, pulse frequency, peripheral saturation (SpO2) are registered and collected 20 minutes post induction.

Eligibility criteria: Inclusion Criteria:

* 80 individuals over 18 years, body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

Exclusion Criteria:

* instable angina pectoris at the day of surgery, severe bronchial asthma or COPD.

Primary outcomes:
measure: Incidence of blood pressure drops
timeFrame: 20 minutes post anesthesia induction
measure: Effect of preoperative fluid bolus
timeFrame: 20 minutes post anesthesia induction
Secondary outcomes:
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: Sunderby hospital
Study officials:
affiliation: Umeå University, Norrbotten county concil
name: Tomi P Myrberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Myrberg T, Lindelof L, Hultin M. Effect of preoperative fluid therapy on hemodynamic stability during anesthesia induction, a randomized study. Acta Anaesthesiol Scand. 2019 Oct;63(9):1129-1136. doi: 10.1111/aas.13419. Epub 2019 Jun 26.
Clinical trial NCT06539533: Pilates on Dynamic Balance in Flexible Flat Feet
Official title: Efficacy of Pilates Training on Dynamic Balance in Flexible Flat Feet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flexible Flatfoot
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Flexible flatfoot is one of the most common types of flatfeet. It has an arch that is present in open kinetic chain and lost in closed kinetic chain Balance is defined as the process that maintains the center of gravity within the body's support base.

Pilates exercises is a whole body conditioning program which was initially used for managing low back pain and improving balance in elderly. Now-a-days it is used for posture correction and fitness training.

Detailed description: Individuals with flatfeet are more unstable when compared with normal individuals during quiet standing. About 10% to 25% of population exhibits a flat foot to varying degrees. In clinical practice, some subjects become symptomatic with feet pain or lower extremity soreness and limitation in their functional activities such as limitation of long-distance walking or running and high-impact sports.Patients with flexible flat feet have poorer static and dynamic balance than healthy individuals. Taking into consideration effect of flat feet on body alignment, the implication of flat feet on balance have received little attention to date Pilates is an individual body-based exercise, it has an advantage in that exercise load can be controlled according to the body's center of balance.Pilates based exercise works on the principles of trunk stability, also known as "core stability". "Core is described as a box, with the abdominals (transversus) in front, paraspinals (multifidus) in back, diaphragm in top and pelvic floor at the bottom". Pilates is a popular form of exercise training program which includes series of stretching and strengthening exercises with proper trunk control and breathing.

Eligibility criteria: Inclusion Criteria:

1. Subject's age ranged from 18-21 years old
2. Subjects had bilateral pronated feet posture according to the Navicular Drop Test by Brody method: normal feet (between five and nine mm of navicular drop), a pronated foot (more than 10 mm of navicular drop)
3. Body Mass Index (MBI) ranged from 18.5 to 25 kg/ m2

Exclusion Criteria:

* 1-Repeated lower extremity injuries as fractures or deformities. 2-History of surgery to the lower extremity. 3- Any neurological deficit affecting balance. 4-Any medication can affect the balance. 5- pregnant and breast feeding females

Primary outcomes:
measure: dynamic balance
timeFrame: 6months
Secondary outcomes:
measure: quialty of life
timeFrame: 6months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT06070233: Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy
Official title: A Randomized, Sham Controlled Trial of Dorsal Root Rhizotomy Stereotactic Radiosurgery Versus Standard of Care for Spasticity Associated With Stroke, Spinal Cord Injury & Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spasticity as Sequela of Stroke
Spastic Cerebral Palsy
Spasticity, Muscle
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
name: Centro Diagnostico Milano, Co-PI: Pantaleo Romanelli, MD
First posted: 2023-10-06
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.


Eligibility criteria: Inclusion Criteria:

* Chronic spasticity refractory to medical management or in a patient who cannot receive appropriate medical management mediated by one or more spinal nerve roots
* Age \> 16 (if under 18, patients parents must sign consent).

Exclusion Criteria:

* Inability to lie supine for simulation \& treatment
* Inability to visualize the target nerve on either CT or MRI imaging
* Patients with confirmed pregnancy (all women of child-bearing age with intact uterus \& ovaries will be required to undergo a pregnancy test prior to simulation)

Primary outcomes:
measure: Change in Modified Ashworth Scale
timeFrame: 6 months post treatment
Secondary outcomes:
measure: Change in spasticity-related quality of life (SQoL-6D)
timeFrame: 2 years post treatment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Milano
country: Italy
facility: Centro Diagnostico Italiano
Study officials:
affiliation: Ohio State University
name: Evan Thomas, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01768533: Pediatric Behavioral Informatics to Prevent Cancer
Official title: Pediatric Behavioral Informatics to Prevent Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: pediatric
obesity
prevention
health behaviors
guidelines
Lead sponsor: University of Massachusetts, Boston
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 305
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population of parents with children ages 4-10 years who reside in the Greater Boston area. Parents are defined as primary care givers or legal guardians who take primary responsibility for the child's health which includes attending the child's well-care visits.

Brief summary: The goal of this study is to do formative research which will lead ultimately to the development of a computer-based system called Tailored Information for Diet and Exercise or TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in children. The system will be used by physicians and parents/primary care givers in pediatric primary care practices with the aim of improving parent-pediatrician interactions related to counseling and anticipatory guidance on energy balance behaviors. The aim of this study is to develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent of the child in the waiting room and assesses topic areas related to energy balance behaviors (EBB). The questionnaire will be referred to as the energy balance behaviors questionnaire (EBB-Q). This will require focus groups, cognitive testing of the questionnaire, and survey administration.


Eligibility criteria: Inclusion Criteria:

* primary care givers or legal guardians of children 4-10 years of age who has attended the last two well-child visits with their child

Exclusion Criteria:

* parent cares for a child who is on a special diet prescribed by pediatrician

Primary outcomes:
measure: sugar-sweetened beverages
timeFrame: one time point (baseline only)
Secondary outcomes:
measure: BMI
timeFrame: one time point (baseline only)
Other outcomes:
measure: Physical activity
timeFrame: one time point (baseline only)
measure: fruit and vegetables
timeFrame: one time point (baseline only)
measure: screen time
timeFrame: one time point (baseline only)
Locations:
city: Boston
country: United States
facility: UMass Boston
state: Massachusetts
Study officials:
affiliation: UMass Boston
name: Julie A Wright, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wright JA, Whiteley JA, Watson BL, Sheinfeld Gorin SN, Hayman LL. Tailored communications for obesity prevention in pediatric primary care: a feasibility study. Health Educ Res. 2018 Feb 1;33(1):14-25. doi: 10.1093/her/cyx063.
citation: Wright JA, Adams WG, Laforge RG, Berry D, Friedman RH. Assessing parental self-efficacy for obesity prevention related behaviors. Int J Behav Nutr Phys Act. 2014 Apr 22;11:53. doi: 10.1186/1479-5868-11-53.
Clinical trial NCT06561633: The Influence Factors of Bispectral Index Values Increment Caused by Sugammadex
Official title: The Influence Factors of Bispectral Index Values Increment Caused by Sugammadex Administration During Steady-state Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BIS
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This observational cohort study was approved by the Institutional Review Board of the Fudan University Shanghai Cancer Center (No.2407-Exp042). Patients with ASA Ⅰ - Ⅱ scheduled for elective surgery who agreed to participate and who signed the informed consent were included.

Brief summary: Sugammadex administration may increase the bispectral index (BIS) values during general anesthesia. The purpose of this study was to investigate the influence factors leading to increase in BIS value caused by sugammadex administration when continuous use of general anesthetics.

Detailed description: Sugammadex administration may increase the bispectral index (BIS) values during general anesthesia. The purpose of this study was to investigate the influence factors leading to increase in BIS value caused by sugammadex administration when continuous use of general anesthetics. Patients undergoing elective surgery were included in this study. After surgery was completed while the train-of-four ratio was zero, a steady-state intravenous anesthesia was maintained to keep a BIS value within the range of 40-60 for at least 5 minutes. Patients received sugammadex 2 mg.kg-1 after completed surgery. BIS values were recorded every minute and clinical signs of awaking was also noted.

Eligibility criteria: Inclusion Criteria:

* Patients with American Society of Anesthesiologists (ASA) physical status Ⅰ - Ⅱ scheduled for elective surgery who agreed to participate and who signed the informed consent were included. Other inclusion criteria were age between 18 and 80 years and scheduled for elective non-cardiothoracic and non-neurological cancer surgery under general anesthesia (GA)

Exclusion Criteria:

* Known hypersensitivity to sugammadex; severe renal insufficiency (creatinine clearance \< 30 ml.min-1); treatment with toremifene, flucloxacillin or fusidic acid in the pre-operative or immediate postoperative period; and neuropsychiatric disorders or treatment with a psychotropic agent.

Primary outcomes:
measure: BIS value
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jun Zhang, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04281433: Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner
Official title: Electromicrographic Activity as Well as Clinical Performance of Bulk Fill Composite With Activa Bioactive Liner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Study of Activa Bioactive Restorative
Dental Caries
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: electromyographic activity as well as clinical performance of bulk-Fill composite resins with Activa Bioactive Liner


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-40 years and cooperative patient.
* Good oral hygiene.
* Normal occlusal relation with normal dentition.

Exclusion Criteria:

* Patient with severe medical problems.
* Tenderness with percussion or pre-operative pulpal pain.
* Mobile tooth and tooth with gingival recession.
* Pregnant or lactating females.
* Cracked teeth or teeth with deep periodontal pockets.
* Tooth with previous restoration.
* Allergy to resin materials.
* Defective restorations adjacent or opposing to tooth.
* Patient with bruxism

Primary outcomes:
measure: Electromyographic activity
timeFrame: baseline (immediate)
measure: Electromyographic activity
timeFrame: one week
measure: Electromyographic activity
timeFrame: after three months
measure: Electromyographic activity
timeFrame: after six months
Secondary outcomes:
measure: Survival rate of restorative material
timeFrame: six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AlAzhar University, Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01208987: Improving Laboratory Follow-up by Delivering an Enhanced Medication List to Outpatient Physician Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Histories in Outpatient Clinic Patients
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2010-09-24
Enrollment: 5256
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators plan to develop a process to create an Enhanced Medication List. The INPC (Indiana Network for Patient Care) already obtains histories of medications dispensed by pharmacies from several sources: pharmacy benefit managers, RxHub, insurance companies, Medicaid, SureScripts, Wishard Health Services. The investigators will collect all the medication data available through the INPC for an individual patient. The investigators will enhance this medication list by including medication categories, improving the structure and appearance, displaying results of relevant laboratory tests, and adding decision support reminders. The investigators will test the value of such an "Enhanced Medication List" by providing it to outpatient physician practices (through the DOCS4DOCS clinical messaging service, or as a fax), preferably on the day that the patient has an office visit with the physician. The investigators will determine whether this intervention improves patient care: whether there are higher rates of recommended laboratory follow-up monitoring as a result; whether there are lower rates of harmful drug-drug interactions. The investigators will also seek the opinions of physicians regarding the benefit of this intervention.


Eligibility criteria: Inclusion Criteria:

* outpatient clinic patient visits

Exclusion Criteria:

* Age 18 and under

Primary outcomes:
measure: Count of medications (on a patient's medication list) for which recent (within 12 months) laboratory test monitoring is missing.
timeFrame: Laboratory tests during the previous 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Regenstrief Institute
state: Indiana
Study officials:
References:
Clinical trial NCT04198987: Dietary Monosaccharide Supplementation in Patients With Congenital Disorders of Glycosylation
Official title: Dietary Monosaccharide Supplementation in Patients With Congenital Disorders of Glycosylation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Disorder of Glycosylation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll patients diagnosed with congenital disorders of glycosylation and started on oral simple sugar supplements as part of their routine clinical care.

Brief summary: Researchers are trying to assess whether the use of simple sugars given as a daily dietary supplement can improve the health of children with congenital disorders of glycosylation (CDG).

Detailed description: The goal of this study is to collect data from patients diagnosed with congenital disorders of glycosylation and taking a simple sugar supplement. The study team wants to expand the evidence on the beneficial effects of this treatment in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patient has a biochemically and genetically proven congenital disorder of glycosylation
* Patient is receiving (or planning to receive) oral simple sugar supplementation

Exclusion Criteria:

* Aldolase B deficiency
* Galactosemia
* Hemolytic uremic syndrome
* Severe anemia
* Galactose intolerance

Primary outcomes:
measure: Measuring effects of oral monosaccharide supplements through growth measurements
timeFrame: length of study, up to 2 years
measure: Measuring effects of oral monosaccharide supplements through blood sugar levels
timeFrame: length of study, up to 2 years
measure: Measuring effects of oral monosaccharide supplements through liver function results
timeFrame: length of study, up to 2 years
measure: Measuring effects of oral monosaccharide supplements through coagulation results
timeFrame: length of study, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Deyle, MD
role: PRINCIPAL_INVESTIGATOR
References: