louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03471598: Reliability, Validity and Responsiveness of the Upright Motor Control Test in Patients With Stroke
Official title: Reliability, Validity and Responsiveness of the Upright Motor Control Test in Patients With Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stroke
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with first-ever, unilateral cerebral stroke within one month

Brief summary: Impaired motor function is common after stroke. Individuals with stroke often exhibit synergic pattern that disturb daily function. It is crucial to identify the movement impairment in the clinical settings. Upright Motor Control Test (UMCT) is one of the tests developed to assess the selective movement control and functional strength in people with central nervous disorders. It can be used to reflect the impairment of motor function and evaluate changes of performance after treatment. Yet is little to know the clinimetrics of the UMCT on clinical utility. To date, only few researches explore that UMCT has some construct and criterion validity.

Therefore, this study aims to 1) establish the inter-rater reliability to administer the UMCT. 2) explore the correlation between the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) and UMCT. 3). investigate whether the UMCT is able to predict the walking ability in patients with stroke.


Eligibility criteria: Inclusion Criteria:

* First-ever, unilateral cerebral stroke within one month
* Being able to maintain standing for more than 10 seconds

Exclusion Criteria:

* Could not follow commands
* Deformity or fracture of lower limb
* Less than 20 years old

Primary outcomes:
measure: Upright Motor Control Test
timeFrame: 1 month
Secondary outcomes:
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke
timeFrame: 1 month
Other outcomes:
measure: 10 Meter Walk Test
timeFrame: 1, 3, 6, and 12 month
measure: 6-Minutes-Waking-Test
timeFrame: 1, 3, 6, and 12 month
measure: Berg Balance Scale
timeFrame: 1, 3, 6, and 12 month
measure: Stroke Rehabilitation Assessment of Movement Measure
timeFrame: 1, 3, 6, and 12 month
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study officials:
affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
name: Bo-Jhen Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00676598: A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest
Official title: A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: therapeutic hypothermia
Lead sponsor: Advocate Hospital System
Sponsor class: OTHER
First posted: 2008-05-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission.

Brief summary: Therapeutic hypothermia has been shown to improve survival and neurologic outcome in patients resuscitated after ventricular fibrillation arrest.

Few studies have examined whether therapeutic hypothermia is effective outside the research setting, or with other presenting rhythms.

Our institution, a large community teaching hospital, instituted a therapeutic hypothermia protocol in November 2006 for all resuscitated cardiac arrest patients.

The investigators seek to determine the mortality rate of our protocol and compare our complication rates with those of previously published studies.

Detailed description: The use of therapeutic hypothermia has been shown to have a beneficial effect on neurologic outcomes of patients resuscitated from cardiac arrest in a limited number of clinical sites. Based on available data, current recommendations from the American Heart Association include a level 2a endorsement of therapeutic hypothermia for cardiac arrest from ventricular fibrillation with persistent coma, and a level 2b recommendation for cardiac arrest from any other rhythm. To date there have been no formal studies presented that demonstrate an improvement in outcome when a hypothermic protocol is implemented in a community hospital. The investigators plan to prospectively collect data on patients enrolled in the therapeutic hypothermia protocol to evaluate clinical outcomes and compare these outcomes with historic controls, with the hypothesis that patients enrolled in the hypothermic protocol will have improved neurologic outcomes.

Eligibility criteria: Inclusion Criteria:

* Any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission.

Exclusion Criteria:

* hypotension (SBP \<90), initial temperature \< 30 °C, trauma, primary intracranial event, or active coagulopathy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oak Lawn
country: United States
facility: Adcovate Christ Hospital
state: Illinois
Study officials:
affiliation: advocate christ medical center
name: Erik B Kulstad, MD,MS
role: STUDY_CHAIR
References:
Clinical trial NCT04412798: Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus
Official title: Impact of Orange Juice During Breakfast on Glycaemic Control in Individuals With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Hochschule Geisenheim University
First posted: 2020-06-02
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal. The aim of the project is to study the impact of the intake of a single serving of 100% orange juice on glycaemic control in male patients with pre-existing type 2 diabetes mellitus. In addition, immunological parameters and Alzheimer disease related biomarkers will be assessed to examine the chronic inflammatory state of these patients


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria: individuals (aged 25-75 years) with up to 8 years of T2DM, according to ADA criteria (Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water; or HbA1c \> ≥6.5% (48 mmol/mol)).

Exclusion Criteria:

* pregnancy,
* participants on exogenous insulin therapy,
* HbA1c \>8.5%,
* BMI \<22 or \>35 kg/m²,
* regular smokers (\>1 cigarette per day),
* participants with established cardiovascular disease,
* neurological disease,
* cancer,
* renal disease.
* Participants who are unwilling to consume any of the standard foods/drinks

Primary outcomes:
measure: Glycaemic responses venous blood
timeFrame: baseline
measure: Glycaemic responses venous blood
timeFrame: Day 5
measure: Glycaemic responses venous blood
timeFrame: Day 10
measure: Insulin responses
timeFrame: Baseline
measure: Insulin responses
timeFrame: Day 5
measure: Insulin responses
timeFrame: Day 10
measure: Capillary glycaemic responses
timeFrame: Baseline
measure: Capillary glycaemic responses
timeFrame: Day 5
measure: Capillary glycaemic responses
timeFrame: Day 10
Secondary outcomes:
measure: Glycated haemoglobin measure
timeFrame: Baseline
measure: Flow cytometry
timeFrame: Baseline
measure: Alzheimer disease related biomarkers
timeFrame: Baseline
measure: BMI
timeFrame: Baseline
measure: Waist/hip circumference (Body composition)
timeFrame: Baseline
measure: Systolic/diastolic blood pressure
timeFrame: Baseline
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Dominique Hansen, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01533298: A Safety, Efficacy Study of CombiflexOmega Peri Versus SmofKabiven Peripheral in Patients With Parenteral Nutrition
Official title: A Randomized, Open, Multicenter, Compared Phase III Trial to Evaluate the Safety, Efficacy of CombiflexOmega Peri and SmofKabiven Peripheral in Postoperative Patients Requiring Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parent
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of CombiflexOmega peri in comparison to SmofKabiven peripheral in postoperative patients requiring parenteral nutrition.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20 and older
* Patients are expected to require PN for more than 3 days
* Patients who voluntarily signed the consent form

Exclusion Criteria:

* Patients are expected difficult to survive more than 3 days
* Pregnant or breast-feeding women
* BMI \> 30 kg/m2
* Patients with severe blood coagulation disorders
* Patients with congenital amino acid metabolism disorders
* Patients with acute shock
* Patients with uncontrollable diabetes mellitus
* Patients with hemophage syndrome
* Patients with hypopotassemia (K \< 3.0mEq/L)
* Patients having the history of myocardial infarction
* Patients reported the following laboratory value

  * fasting TG \> 250mg/dl, TC \> 300mg/dl
  * ALT/AST ≥ 2×ULN, Bilirubin ≥ 3mg/dl (Exception : patients with periampullary carcinoma including biliary tract or pancreas)
  * Creatinine ≥1.5mg/dl
  * Ca \> 11.2mg/dl, Na ≥ 145mEq/L, Mg ≥ 2.1mEq/L, K ≥ 5.5mEq/L
* Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
* Patients having the history of drug or alcohol abuse
* General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, cardiac decompensation
* Patients are in unstable conditions
* Patients with difficult peripheral intravenous
* Patients with parenteral nutrition within 7 days prior to start of the trial
* Participation in another clinical study with an investigational drug or an investigational medical device within 28 days prior to start of study
* Patients judged to be unsuitable for this trial by investigators

Primary outcomes:
measure: Comparison of adverse drug reaction
timeFrame: 4days
Secondary outcomes:
measure: Changes of laboratory parameters (biochemistry, hematology, coagulation)
timeFrame: 5days
measure: Changes of vital signs
timeFrame: 5days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
Clinical trial NCT04948398: Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis
Official title: Post-Trial Access for Guselkumab in Patients With Familial Adenomatous Polyposis Who Are Experiencing Clinical Benefit After Completing 48 Weeks of Treatment in CNTO1959COR1001
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Adenomatous Polyposis Coli
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-07-02
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this post-trial access (PTA) program is to provide guselkumab to participants with Familial Adenomatous Polyposis (FAP) who are experiencing clinical benefit after completing 48 weeks of treatment in Study CNTO1959COR1001.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01225198: Vitamin/Mineral Supplement for Children and Adults With Autism
Official title: New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism
Keywords: Vitamins
Minerals
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Autism Research Institute
name: Legacy Foundation
First posted: 2010-10-20
Enrollment: 143
Sex: ALL
Minimum age (years): 3
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in:

1. improvement of nutritional status in some children/adults with autism, and
2. reduction of some of the symptoms of autism in some children

Detailed description: The major goal of this study is to determine the effect of this vitamin/mineral supplement on levels of vitamins, minerals, neurotransmitters, and biomarkers for nutritional deficiencies. The study design is a randomized, double-blind, placebo-controlled. Blood and urine measurements will be measured at the beginning of the study in children with autism and typical children. Then, the children with autism will be given the supplement or placebo for 12 weeks, and then their blood and urine will be re-measured.

Eligibility criteria: Inclusion Criteria:

1. age 3-60 years old;
2. Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional
3. Control Group: in good mental and physical health, and no siblings with autism spectrum disorders, and no evidence of Attention Deficit Disorder by parent report

Exclusion Criteria:

1. Usage of a vitamin/mineral supplement in the last 2 months
2. Current use of any chelation treatment

Primary outcomes:
measure: Oxidative Stress
timeFrame: Beginning of study (day 0)
measure: Oxidative Stress
timeFrame: End of Study (after 12 weeks of treatment)
Secondary outcomes:
measure: Parent Global Impressions - Revised
timeFrame: End of study (12 weeks)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: James B. Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adams JB, Audhya T, McDonough-Means S, Rubin RA, Quig D, Geis E, Gehn E, Loresto M, Mitchell J, Atwood S, Barnhouse S, Lee W. Effect of a vitamin/mineral supplement on children and adults with autism. BMC Pediatr. 2011 Dec 12;11:111. doi: 10.1186/1471-2431-11-111.
Clinical trial NCT02430298: Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients
Official title: Topical and Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis and Xerostomia in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Ubon Ratchathani Cancer Hospital, Ubon Ratchathani
name: General Drugs House Co.,LTD.
First posted: 2015-04-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy induced oral mucositis and xerostomia and improving quality of life in head and neck cancer patients. This is a randomized, double-blind, placebo controlled trial conducted in head and neck cancer patients. Mixed-block randomization is used to divide eligible patients into two groups: melatonin 40 mg or matched placebo. The patients are required to take the studied drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5 fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H\&N), pain (VAS 0-10) and adverse event frequency.


Eligibility criteria: Inclusion Criteria:

* New diagnostic of head and neck cancer patient who need treatment with radiation involved with the oral cavity area.
* Never received radiotherapy or chemotherapy
* Karnofsky performance status \> 70%
* Stopped smoking
* Able to eat and swallow medications
* Written informed consent

Exclusion Criteria:

* Melatonin allergy
* Active oral cavity inflammation scar
* Pregnancy
* Creatinine clearance \< 30 ml/min
* Active periodontal disease
* Steroids or pain killer drugs used for oral cavity pain except NSAIDs for thromboembolism prevention
* Currently use benzydamine mouthwash

Primary outcomes:
measure: Percentage of occurrence of mucositis level 3 or more by using the criteria of CTCAE version 4.0, World Health Organization scale and MTSscores
timeFrame: Time to event (occurence of mucositis level 3) during 7 weeks of treatment
Secondary outcomes:
measure: Percentage of occurrence of xerostomia level 2 or more by using the criteria of CTCAE version 4.0 and the Visual Analogue Scale
timeFrame: Time to event (occurence of mucositis level 3) during 7 weeks of treatment
measure: Quality of Life (FACT- H&N Version 4)
timeFrame: Change from baseline in Trial Outcome Index scores at 7th week
Other outcomes:
Locations:
city: Ubon Ratchathani
country: Thailand
facility: Ubon Ratchathani Cancer Hospital
Study officials:
References:
Clinical trial NCT01140698: Amino Acid Profile in the Fetus and the Neonate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cord Blood Amino Acid Profile
Fetal Amino Acid Profile in Different Gestational Ages
Infant Amino Acid Profile at Day 3 and Discharge
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-06-09
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Term and preterm newborn infants

Brief summary: Up-to-date, the preterm newborn nutrition is based on human breast milk or it's imitations. However, the growth rate is known to be reduced compared to the fetal growth rate. In order to attempt a better growth rate of the preterm newborn infants it is important to evaluate the metabolic components of the fetal blood and try to find components that might influence its growth.

Little is known of the metabolic components of the fetal blood, including amino acid profile. The aim of the study is to evaluate amino acid profile in the fetus blood in different gestational ages and compare it to post natal period.


Eligibility criteria: Inclusion Criteria:

* All new-born infants 5 of each gestational age

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba medical center
Study officials:
References:
Clinical trial NCT04800198: Intraoral Measurement of Pressure in Preterm Infants
Official title: Intraoral Measurement of Pressure in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Infants
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborns, in hospital

Brief summary: The aim of the study is to show pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies

Detailed description: The aim of the investigation is to show the pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies, with a number large enough for an analysis. For this purpose, the pressure in the nasopharynx of these children is to be measured using a suction catheter, as is usually used to suction off mucus and saliva, and the measured values are to be evaluated with software. This method is a tried and tested method in adults for measuring the pressure conditions in the nasopharynx, which was developed and used by Mr. Olthoff. A possible later clinical application in premature and newborn infants ranges from the measurement of breathing and ventilation to manual control of respiratory support depending on the measured value to automatic triggering and control of a ventilator in the sense of nSIPPV ventilation (non-invasive synchronized intermittent positive pressure ventilation )

Eligibility criteria: Inclusion Criteria:

newborns, non-invasive ventilation

Exclusion Criteria:

* Bad clinical condition of the patient (e.g. sepsis)
* Bleeding tendency
* Anatomical peculiarities that make it difficult to insert the suction catheter through the nose (e.g. choanal atresia)
* Lack of acceptance of the probe by the child
* Proven infection / colonization of the child by a multi-resistant germ (MRGN 2-4, MRSA) or with noro- / adenoviruses
* Missing / withdrawn consent by the legal guardians

Primary outcomes:
measure: Median Pressure reached by any tape of non-invasive ventilation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medicine Göttingen
Study officials:
affiliation: University Medical Center Goettingen
name: Helmut Küster, MD
role: PRINCIPAL_INVESTIGATOR
References: