louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01662414: Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease
Official title: Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease: Changes in Biomarkers of Oxidative Stress, Profiles of Plasma Amino Acids and Their Derivatives and Brain Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a double-blind, placebo-controlled, Phase IV trial , comparing HMS 90® versus placebo (soy protein) as add-on (adjuvant) therapy in subjects with idiopathic Parkinson's Disease.

The principal objective is to evaluate the changes in biomarkers of oxidative stress and,plasma amino acids, as well as improvement of clinical symptoms and brain function


Eligibility criteria: Inclusion Criteria:

1. Subjects with Idiopathic Parkinson's Disease
2. Subjects who are willing and able to participate in the trial and has provided written, informed consent.

Exclusion Criteria:

1. Subjects who are allergic to Whey protein (HMS 90®).
2. Subjects who are treated with chemotherapy .
3. Subjects with any history of neurodegenerative diseases, e.g., Alzheimer's disease.
4. Subjects with history of diabetes. 4.5. Subjects with abnormal liver function test

Primary outcomes:
measure: Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status
timeFrame: 6 months
measure: Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan
timeFrame: 6 months
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24
timeFrame: 6 months
measure: Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24
timeFrame: 6 months
measure: • Clinical Global impression (CGI) - Change scale score, change from baseline to week 24
timeFrame: 6 months
measure: • Clinical Global impression (CGI) - Severity scale score change from baseline to week 24
timeFrame: 6 months
measure: • Parkinson's Disease quality of life questionnaire score change from baseline to week 24
timeFrame: 6 months
measure: Nutrition Questionnaire score change baseline to week 24
timeFrame: 6 months
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
facility: Chulalongkorn University Hospital
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Roongroj Bhidayasiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03149614: Clinical Effects in Cervical Spinal Mobilization and Oscillation Mobilization in Neck Pain
Official title: Clinical Effects in Cervical Spinal Mobilization Versus Resonant Oscillation Mobilization (POLD) in Neck Pain. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Manual Therapy
Neck Pain
Keywords: mobilization
resonant oscillation
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the clinical effects of spinal mobilization versus vertebral resonant oscillation (POLD) in patients with bilateral mechanical neck pain on pain sensitivity and neck pain intensity.

Detailed description: The clinical practice guidelines for manual therapy management the neck pain including the spine mobilization.

The vertebral resonant oscillation using the POLD method is similar to spine mobilizations, but there are some differens; the oscillatory movement has a sinusoidal waveform, the frequency used between 1.2 and 2 Hz and the amplitude is similar to "neutral zone" to described by Panjabi 1992.

The spinal mobilizations has a posterior-anterior vertebral movement for spinous process, described by Maitland 2000.

Eligibility criteria: Inclusion Criteria:

* neck pain symptoms of mechanical nature
* age from 18 to 60 years
* bilateral symptoms
* symptoms for at least 3 month of duration

Exclusion Criteria:

* whiplash injury
* previous spine surgery
* diagnosis of cervical radiculopathy or myelopathy
* having undergone any physical therapy intervention in the previous 6 month
* pregnancy

Primary outcomes:
measure: Changes in pain intensity before and after the intervention
timeFrame: Baseline, one week after the last session, 1 months and 3 months after the last session.
Secondary outcomes:
measure: Changes in disability before and after the intervention
timeFrame: Baseline, one week after the last session, 1 months and 3 months after the last session.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Rey Juan Carlos
Study officials:
References:
Clinical trial NCT04843514: TDM of Asparaginase in ALL2008
Official title: Therapeutic Drug Monitoring of Asparaginase in Patients Treated on the NOPHO ALL2008 Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 765
Sex: ALL
Minimum age (years): 1
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Alle patients in the NOPHO countries aged 1-45 years treated for ALL on the NOPHO ALL2008 protocol and have asparaginase-activity-samples sent to Aarhus.

Brief summary: Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in NOPHO ALL2008 prolonged asparaginase treatment has been implemented.

Publish data from NOPHO ALL2008 show sufficient treatment of the majority of patients (analysing trough levels of asparaginase after 2 weeks) but 13% of the patients experience an allergic reaction to this foreign protein (85% of them after the 2nd or 3rd dose) and they have no enzyme activity even before the reaction, meaning that they don't benefit from the treatment at all. In addition 4-5% of the patients have no enzyme activity through the whole treatment without hypersensitivity symptoms. So in reality approximately 20% of the patients don't receive any asparaginase treatment. Therapeutic Drug Monitoring (TDM) of asparaginase has been established in Aarhus, Denmark, under the leadership of Birgitte Klug Albertsen (BKA). From February 2017 the centers have been invited to send samples (extended sampling) in order to gain more knowledge about the pharmacokinetics, to identify patients without activity and to establish the logistics for TDM of asparaginase, which will be mandatory in the next protocol ALLTogether, presumably opening in 2018.

From February 2016 an extended sampling for enzyme activity measurements was started and will continue until NOPHO ALL2008 closes. These samples will make it possible to do more in depth pharmacokinetic studies as well as identify the optimal sampling time points for identifying no-activity patients in the future.

A database is being developed for TDM in ALLTogether, but it will also include all the asparaginase measurements in ALL2008.


Eligibility criteria: Inclusion Criteria:

* ALL treated on the NOPHO ALL2008 protocol, age 1-45 years.

Exclusion Criteria:

* No samples sent

Primary outcomes:
measure: Description of the pharmacokinetics after administration of PEG-asparaginase 1000 IU/m2 in NOPHO ALL2008, cohort February 2017 and on
timeFrame: 2018-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital, Denmark
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT01632514: Vitamin D Deficiency and Postoperative Hypocalcemia
Official title: Correction of Vitamin D Deficiency to Prevent Postoperative Hypocalcemia After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypocalcemia
Keywords: hypocalcemia
vitamin D deficiency
cholecalciferol
thyroidectomy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-07-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypocalcemia is a frequent adverse event after thyroidectomy. It is usually related to hypoparathyroidism, but preoperative hypocalcemia, hypomagnesemia or vitamin D deficiency contributes to it. This study aims to determine the frequency of vitamin D deficiency or insufficiency in patients submitted to thyroidectomy, to define the risk attributed to vitamin D deficiency to postoperative hypocalcemia, to identify other factors associated to postoperative calcium disorder, and to evaluate the benefit of preoperative treatment of vitamin D deficiency to prevent postoperative hypocalcemia.

Detailed description: Subjects to be submitted to total thyroidectomy will be included in the study. The investigators will evaluate serum levels of total calcium, ionic calcium, phosphorus, magnesium, creatinine, albumin, alkaline phosphatase, fasting glucose, thyroid stimulating hormone (TSH), free thyroxin (FT4), intact parathyroid hormone (PTH), 25 hydroxy vitamin D (25OHD), osteocalcin, C-terminal telopeptide (CTX) and procollagen type 1 amino-terminal propeptide (P1NP). Patients will be randomized to 3 groups: (1) 30 subjects with 25OHD \< 20 ng/mL that will receive 100,000U of cholecalciferol weekly for 4 weeks before surgery, (2) 30 subjects with 25OHD \< 20 ng/mL that will not receive cholecalciferol before surgery and (3) 30 controls with 25OHD \>= 20 ng/mL that will not receive cholecalciferol before surgery. Afterwards, the investigators will evaluate immediate postoperative PTH and measure serum levels of total calcium, ionic calcium, magnesium, alkaline phosphatase, osteocalcin, CTX and P1NP in first and second postoperative days for further analysis.

Eligibility criteria: Inclusion Criteria:

* patients that will be submitted to total thyroidectomy

Exclusion Criteria:

* \< 18 year-old
* chronic renal failure (creatinine \> 1.5 mg/dL)
* fasting glucose \> 200 mg/dl
* albumin \< 3.5 g/L
* preoperative use of calcium supplements, bisphosphonates, corticosteroids

Primary outcomes:
measure: postoperative hypocalcemia
timeFrame: up to 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Debora LS Danilovic, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02597114: Extension Study of AGT-181-102 to Evaluate Long Term Safety and Activity of AGT-181
Official title: An Extension Study of AGT-181-102 Evaluating Safety and Glycosaminoglycans (GAGs) in Adult Patients With Hurler-Scheie or Scheie Syndrome Who Have Completed 8-Weeks of Dosing With AGT-181 in Study AGT-181-102
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mucopolysaccharidosis I
Lead sponsor: ArmaGen, Inc
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This study is an extension of a safety and dose ranging study to obtain long term safety and exposure data, as well as information on the biological activity of the investigational drug


Eligibility criteria: Inclusion Criteria:

* Must have completed clinical trial AGT-181-102
* Voluntary written consent by patient or legally responsible representative
* All women of childbearing potential and sexually mature males must be advised to use a medically accepted method of contraception throughout the study.
* Negative pregnancy test (females)

Exclusion Criteria:

* Refusal to complete screening evaluations.
* Any medical condition or other circumstances that may significantly interfere with study compliance
* Patient is pregnant or lactating
* Clinically significant spinal cord compression, evidence of cervical instability.
* Subject developed clinically relevant hypersensitivity to AGT-181

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 104 weeks (2 years)
Secondary outcomes:
measure: changes in urinary or plasma glycosaminoglycans (GAGs)
timeFrame: 104 weeks (2 years)
measure: change in liver size
timeFrame: 104 weeks (2 years)
measure: change in spleen size
timeFrame: 104 weeks (2 years)
measure: change in levels of heparan sulfate and dermatan sulfate in the cerebrospinal fluid
timeFrame: 104 weeks (2 years)
Other outcomes:
Locations:
Study officials:
affiliation: ArmaGen, Inc
name: Patrice Rioux, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01236014: Indirect Comparison Between Eltrombopag & Romiplostim
Official title: Indirect Comparison of Efficacy of Treatments for Idiopathic Immune Thrombocytopenic Purpura - Review of Platelet Responses and Bleeding Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocytopaenia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-11-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Identified through a systematic review: TRA102537, Kuter 2008

Brief summary: An indirect comparison to compare the efficacy of eltrombopag versus romiplostim

Detailed description: An indirect analysis was conducted to evaluate the relative efficacy of eltrombopag and romiplostim using placebo as a common comparator

Eligibility criteria: Inclusion Criteria:

* Adults with ITP
* Pre-specified treatment
* Prospective clinical studies with at least 10 patients

Exclusion Criteria:

* Adults with ITP for other reasons

Primary outcomes:
measure: Durable response: platelet count of >=50 and <400 Gi/L
timeFrame: 6 months
measure: Overall response: either a durable response or a transient platelet response
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01805414: Breakfast Nutrition and Inpatient Glycemia
Official title: The Effect of a Targeted Breakfast Intervention on Inpatient Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Type 1
Diabetes, Type 2
Cardiovascular Disease
Hyperglycemia
Keywords: inpatient diabetes
inpatient diabetes nutrition
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: A standard hospital meal often contains a high percentage of carbohydrates (CHO), which may not be ideal for patients with diabetes. This concern is particularly pertinent to the breakfast meal, which often contains mainly CHO. Clinical observations suggested that such diets elevate pre-lunch blood glucose (BG) values. The study team compared standard hospital "no concentrated sweets (NCS)" breakfast meals with more balanced meals. The study team hypothesized that a balanced breakfast would improve pre-lunch BG values.

This 8-week pilot study was conducted at Duke Hospital on two non-ICU cardiology wards. Ward A consisted mainly of patients with a primary diagnosis of coronary artery disease (CAD). Ward B consisted mainly of patients with a primary diagnosis of congestive heart failure (CHF). The intervention breakfast menu included 5 choices containing 40-45g of CHO. All patients on Ward A (with and without diabetes) were given the intervention breakfast for the first 4 weeks of the study, while those on Ward B received standard menus (60-75g CHO in NCS meals). After 4 weeks, the standard and intervention wards were switched. Data were collected only on patients with diabetes who were able to consume meals.


Eligibility criteria: Inclusion Criteria:

* Adults with cardiovascular disease who were admitted to 2 pre-specified wards at Duke Medical Center during the study period
* Diagnosis of diabetes (type 1 or 2) or newly identified hyperglycemia (blood glucose of \>200 on 2 separate occasions)
* Able to consume food by mouth

Exclusion Criteria:

* Intensive care patients
* No intake by mouth (enteral, parenteral, NPO)
* Taking in nutrition supplements (Ensure, etc)

Primary outcomes:
measure: Relative change in Blood sugar
timeFrame: Pre-breakfast to pre-lunch, approximately 4 hours, daily for the study duration of 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
Study officials:
affiliation: Duke Medical Center
name: Lillian F Lien, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Medical Center
name: Kathryn J Evans, NP
role: STUDY_DIRECTOR
affiliation: Duke Medical Center
name: Mark N Feinglos, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00237614: Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Contrast-Induced Nephropathy
Acute Myocardial Infarction
Keywords: Contrast-induced nephropathy
Acute myocardial infarction
Primary coronary angioplasty
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2005-10-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with acute myocardial infarction undergoing primary angioplasty are at high risk for renal injury due to the toxic effect of contrast agents. Patients developing renal dysfunction after primary angioplasty have worse outcome. To investigate the role of the antioxidant N-acetylcysteine (NAC) in preventing renal injury in angioplasty, we randomized 352 consecutive patients undergoing primary angioplasty into three groups: the first group received NAC at standard dose (NAC group, 600 mg i.v. bolus before primary angioplasty, followed by oral 600 mg twice daily for the following 48 hours; n=115), the second group received NAC at double dose (DD-NAC group; 1,200 mg i.v. bolus and oral 1,200 mg twice daily for 48 hours; n=118), and the last group received placebo (controls; n=119).


Eligibility criteria: Inclusion Criteria:Consecutive patients admitted to the Coronary Care Unit for ST-segment elevation acute myocardial infarction undergoing primary angioplasty. Patients were included if they presented within 12 hours (18 hours for acute myocardial infarction complicated by cardiogenic shock) from the onset of symptoms. -

Exclusion Criteria:Patients in chronic peritoneal or hemodialytic treatment and those with known allergy to N-acetylcysteine.

-

Primary outcomes:
measure: Incidence of contrast-induced nephropathy
Secondary outcomes:
measure: In-hospital major clinical adverse events including death
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
Study officials:
affiliation: Centro Cardiologico Monzino
name: Antonio L Bartorelli, MD
role: STUDY_DIRECTOR
References:
citation: Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. doi: 10.1016/j.jacc.2004.07.043.
citation: Marenzi G, Assanelli E, Marana I, Lauri G, Campodonico J, Grazi M, De Metrio M, Galli S, Fabbiocchi F, Montorsi P, Veglia F, Bartorelli AL. N-acetylcysteine and contrast-induced nephropathy in primary angioplasty. N Engl J Med. 2006 Jun 29;354(26):2773-82. doi: 10.1056/NEJMoa054209.
Clinical trial NCT00531414: Inspiratory Flow Using the Osmohaler
Official title: Inspiratory Flow and VOlumes in Asthmatic and Healthy Individuals Using the Osmohaler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthmatic
healthy
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The OsmohalerTM is a registered device in Australia. It is used to deliver a dry powder a commercial preparation of mannitol registered as AridolTM to test if a person has irritable airways such as active asthma.

The overseas regulatory authorities need to know that people of all ages can achieve an adequate inspiratory flow through this device during a controlled deep inspiration. Adequate flow is generally regarded as greater than 30 litres per minute in children and 60 litres per minute in adults. The OsmohalerTM is a device with low resistance and is already in use in Australia to deliver mannitol. However there is a need to document inspiratory flows through the device during a controlled deep inspiration. The protocol requires subjects to perform a controlled deep inspiration from the device on three or five occasions. No substance will be inhaled.


Eligibility criteria: Inclusion Criteria:

* has asthma or is healthy
* aged 6 to 69 years inclusive
* FEV1 \>/= 70% predicted

Exclusion Criteria:

* has condition contraindicating performance of spirometrt

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
name: Sandra Anderson
role: PRINCIPAL_INVESTIGATOR
References: