louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00457444: Study to Assess the Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutanous Allergen Administration
Official title: ZU-SkinSIT-001 Single Center Phase I/IIa, Placebo Controlled, Randomized, Double Blind Study to Assess the Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutanous Allergen Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rhinoconjunctivitis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-04-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective Comparison of the inhibition of the allergic response assessed by nasal provocation test after epicutanous pollen allergen administration and placebo epicutaneous administration.

Secondary Objectives Comparison of the efficacy of the placebo with that of the epicutanous pollen allergen administration evaluated by visual analog symptom scales (nasal itching, sneezing, rhinorrhea, conjunctival redness, and lacrimation, lung symptoms ), Comparison of the inhibition of the allergic response assessed by skin prick test after epicutanous pollen allergen administration and placebo epicutaneous administration.

* Trial with medicinal product


Eligibility criteria: Inclusion criteria:

* Written informed consent
* History of grass pollen allergic rhinitis
* Male and female between 18 years to 65 years
* Positive skin prick test to grass pollen
* Positive nasal provocation test

Exclusion criteria:

* Atopic eczema in history or permanent
* Perennial allergic rhinitis
* Symptoms of infectious disease with rhinitis in between the last 2 weeks
* Surgical intervention in between the last 30 days
* Pregnancy or nursing
* History of HIV or AIDS
* Mastocytosis (cutaneous or systemic)
* Significant cardiovascular disease
* Hypertension (blood pressure \> 160 / 95)
* Significant pulmonary, renal and/or hepatic disease
* Significant hematological disorder
* Moderate or severe asthma
* History of malignancy
* History of neurological or psychatric disease
* Autoimmune disease
* Antihistamines with longed half-lives in the last week
* Systemic or topical steroids for 5 days
* Active infectious disease
* Contraindicated medications: - immunosuppressive agents

  * Betablockers
  * ACE-inhibitors
  * Tricyclic antidepressants
  * Daily use of Beta-agonists or steroid inhalers
* Participation in another clinical trial /study in between the last 60 days
* Participation in another clinical trial / study at the moment

Primary outcomes:
measure: efficacy
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT03945344: Effect of Charcoal on Gastrointestinal Absorption of Tiotropium
Official title: Effect of Charcoal on Gastrointestinal Absorption of Tiotropium; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2019-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will assess how efficiently activated charcoal will block absorption of tiotropium via the gastro intestinal track. Pharmacokinetics of tiotropium will be compared after orally administered tiotropium capsule with and without concomitant activated charcoal administration in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent (IC) obtained.
2. Healthy males and females, aged 18-60
3. Normal weight at least 50 kg.

Exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
3. Any clinically significant abnormal laboratory value or physical finding that may interfere the interpretation of study result or constitute a health risk for the subject if he/she participates in the study.
4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or to the excipients of the drug.
5. Pregnant or lactating females.
6. Females of childbearing potential not using proper contraception.

Primary outcomes:
measure: The pharmacokinetic parameter Area Under Curve (AUC)
timeFrame: 24 hours
Secondary outcomes:
measure: Peak concentration in plasma (Cmax) and time to reach peak concentration in plasma (tmax)
timeFrame: (0 hours) and at 15, 30 and 45 minutes, and 1,1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours after the administration
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Maria Annunen, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01786044: The Impact of a "Serious Game" on Improving Patient's Medication Knowledge
Official title: The Impact of a "Serious Game" on Improving Patient's Medication Knowledge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Keywords: patient education
primary health care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the effects of an interactive educational program delivered through a patient portal on patients' medication knowledge and medication adherence.


Eligibility criteria: Inclusion Criteria:

1. MGH Internal Medical Associates patients
2. are age of 18 or older,
3. have at least two medications on their medication list that match our pre-selected medications,
4. have at least three medical conditions on their problem list that match our pre-selected medical conditions,
5. have at least three medications documented on their medication list, and
6. list English as their primary language.

Exclusion Criteria:

-

Primary outcomes:
measure: medication knowledge
timeFrame: 3 months
measure: medication adherence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital, Internal Medicine Associates
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital, Laboratory of Computer Science
name: William Lester, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000444: Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)
Official title: Timing of Smoking Intervention in Alcohol Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Smoking
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 1999-11-03
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study will attempt to determine the best time to begin a smoking cessation program in individuals who undergo intensive treatment for alcohol dependence. The goal of this trial is to determine whether a smoking cessation program is more effective if it occurs at the same time as or after treatment for alcohol dependence. The study also will attempt to determine the effect of smoking cessation programs on the outcome of treatment for alcohol dependence.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for alcohol use disorder and other drug dependence.
* Complete first week of alcohol treatment program.
* Current cigarette smoker (more than 5 cigarettes/day, smoking more than 1 year).

Exclusion Criteria:

* Lifetime diagnosis of an excluding psychiatric disorder: bipolar disorder, schizophrenia or other psychotic disorder, panic disorder with or without agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder, eating disorder, post- traumatic stress disorder, antisocial personality disorder, or borderline personality disorder.
* Unable to participate in protocol due to functional deficits or severe depression.
* Suicidal or homicidal ideation.
* Current use of disulfiram (Antabuse) or naltrexone (Revia).
* Current use of pipes, cigars, or smokeless tobacco and unwillingness to stop.
* Lives more than 100 miles from alcohol treatment facility.
* No telephone.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: General Internal Medicine, VA Medical Center
state: Minnesota
Study officials:
References:
Clinical trial NCT04284644: Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques
Official title: A Novel Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques: a Prospective Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Anesthesia; Adverse Effect
Keywords: General anesthesia
Propofol
Sevoflurane
Co-induction
Laryngeal mask airway
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 105
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction.

Detailed description: Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. This technique is considered an approach that can be of a great benefit to patients with chronic medical illnesses and those who have moderate to high risk for general anaesthesia.

In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction. The investigators evaluated the time needed for laryngeal mask airway (LMA) insertion, number of LMA insertion trials, succession of LMA insertion, adverse events related to the airway, respiratory and cardiovascular systems, haemodynamic stability and satisfaction scores of enrolled patients.

Eligibility criteria: Inclusion Criteria:

* patients with Age ≥ 65 years.
* American Society of Anaesthesiologists' (ASA) score II or III.
* minimally invasive endoscopic urological procedures.

Exclusion Criteria:

* patient refusal.
* Age \< 65 years.
* family history of malignant hyperthermia.
* prolonged surgery that needed intubation.
* body mass index (BMI) \> 35 kg/m2.

Primary outcomes:
measure: Intraoperative respiratory adverse events
timeFrame: 8 months
Secondary outcomes:
measure: Time for successful laryngeal mask airway insertion
timeFrame: 8 months
measure: Blood pressure stability
timeFrame: 8 months
measure: Heart rate stability
timeFrame: 8 months
measure: Changes in oxygen saturation
timeFrame: 8 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
References:
Clinical trial NCT01477944: Pattern of Statins Use in Catalonia
Official title: Pattern of Statins Use in Catalonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesteremia
Keywords: Statins pattern of use
Hypercholesterolemic patients
Statins
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-11-23
Enrollment: 180723
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypercolesterolemic patients in treatment with statins.

Brief summary: To describe the new statins prescription pattern in Catalonia (getting their first prescription for any statin, or receiving a change in their statin treatment including switching, changing in doses or adding ezetimibe/fibrates) since September 2009.

Detailed description: Pattern of statins use in Catalonia.

Eligibility criteria: Inclusion Criteria

* Patient with a new prescription of statin Patients receiving one or more changes of the statins treatment

Exclusion Criteria

* Patient with not full information

Primary outcomes:
measure: Description of detailed clinical treatment in terms of duration of treatment, doses, drug switches and add-on therapy, in patients with hypercholesterolemia and on treatment with statins from the index date.
timeFrame: From 1st September 2009 to 30th August 2010
measure: Type of prescriber
timeFrame: From 1st September 2009 to 30th August 2010
measure: Date of change from previous statin to new.
timeFrame: From 1st September 2009 to 30th August 2010
Secondary outcomes:
measure: Description of demographic data including: Sex, Age, Height (cm), Weight (kg), Smoking habits (packs-years), Alcohol consume habits (units/week), active worker or retired, Pregnancy.
timeFrame: From 1st September 2009 to 30th August 2010
measure: Total cholesterol
timeFrame: From 1st September 2009 to 30th August 2010
measure: Low Density Lipoprotein (LDL) cholesterol concentration
timeFrame: From 1st September 2009 to 30th August 2010
measure: High Density Lipoproteins (HDL) cholesterol concentration
timeFrame: From 1st September 2009 to 30th August 2010
measure: Triglicerides (TG) concentration
timeFrame: From 1st September 2009 to 30th August 2010
measure: Aspartate Aminotransferase (ASAT) concentration
timeFrame: From 1st September 2009 to 30th August 2010
measure: Serum Glucose concentration
timeFrame: From 1st September 2009 to 30th August 2010
measure: Serum Creatin Kinase (CK) concentration
timeFrame: From 1st September 2009 to 30th August 2010
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01955044: PUFA Supplementation in Premature Infants
Official title: Early DHA Supplementation in Extremely Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature, Extremely Low Birth Weight Infants
Polyunsaturated Fatty Acid Levels
Keywords: neonatal prematurity
infant, extremely low birth weight
fatty acids, polyunsaturated
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Northwestern University Feinberg School of Medicine
name: Mead Johnson Nutrition
First posted: 2013-10-07
Enrollment: 30
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.

Detailed description: This will be a multi-center, randomized, placebo controlled, double blind trial.

Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.

ELBW infants will be enrolled into this study.

Eligibility criteria: Inclusion Criteria:

* a) Premature infant born at gestational age less than 34 weeks
* b) Birth weight less than 1000 grams
* c) Legally authorized representative is able to provide written informed consent within the first 72 hours of life, prior to the performance of an protocol-specified evaluations or procedures

Exclusion Criteria:

* a) infants with known metabolic disorder
* b) infants with known congenital gastrointestinal anomaly
* c) infants who are deemed to be inappropriate for enrollment per attending neonatologist

Primary outcomes:
measure: Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels
timeFrame: 2 weeks of life
Secondary outcomes:
measure: LCPUFA Levels
timeFrame: 8 weeks of life
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Michael S Caplan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robinson DT, Caplan M, Carlson SE, Yoder R, Murthy K, Frost B. Early docosahexaenoic and arachidonic acid supplementation in extremely-low-birth-weight infants. Pediatr Res. 2016 Oct;80(4):505-10. doi: 10.1038/pr.2016.118. Epub 2016 Jun 3.
Clinical trial NCT06670092: Effect of Vojta Therapy on Motor Control in Children With Attention Deficit Hyperactivity Disorder
Official title: Effect of Vojta Therapy on Motor Control in Children With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention-Deficit/Hyperactivity Disorder
Vojta Therapy
balance
postural control
visual motor coordination
manipulative skills
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ADHD is generally associated with significant comorbidities including motor disorders in up to 96% of cases. Within these, disturbances of balance and motor coordination that interfere with school learning and daily activities are present in 47% of school children with ADHD. Therefore, the aim of this research is to determine whether Vojta therapy is beneficial for the improvement of balance, postural control, hand-eye coordination and manipulative motor skills in children with ADHD, hyperactive and/or combined, aged 6-12 years.


Eligibility criteria: Inclusion Criteria:

1. Have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) of the combined or hyperkinetic type.
2. Be between 6 and 12 years of age.
3. Be under treatment with methylphenidate.
4. IQ of 100 or higher.
5. Have a normal neurological examination.
6. Not dysmorphic.
7. Not have received specific physiotherapy treatment for the improvement of balance and postural control in the two months prior to inclusion in the study.

Exclusion Criteria:

1. Present a diagnosis of ADHD comorbid with other neuropsychiatric pathologies.
2. Have a history of neurological or musculoskeletal disorders that are linked to a deficit in balance and/or postural control.
3. Be under treatment with atomoxetine.

Primary outcomes:
measure: Sensory organisation test (NEUROCOM dynamic posturology)
timeFrame: 15 minutes
Secondary outcomes:
measure: Paediatric Balance Scale
timeFrame: 15 minutes
measure: Bruininks-Oseretsky Test (abbreviated version)
timeFrame: 10 minutes
measure: Paediatric Quality of Life Questionnaire
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References:
Clinical trial NCT02412592: Sustained Viral Response in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion After Interferon Therapy
Official title: Sustained Viral Response and Clincal Relapse in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion by Interferon Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Keywords: HBeAg positive
interferon
peginterferon
HBeAg seroconversion
sustained viral response
relapse
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 260
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: NON_PROBABILITY_SAMPLE
Study population: The study population in this study were composed of HBeAg positive chronic hepatitis B patients achieved HBeAg seroconversion by interferon treatment, and serum HBsAg, anti-HBs, HBeAg, anti-HBe, and HBV DNA would be tested every 3 months for 156 weeks after finished treatment. The sustained viral response defined HBV DNA mantaining undetectable would be evalued during the observation period.

Brief summary: Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBeAg seroconversion is considered to be the satisfied endpoint of antiviral therapy in HBeAg-positive chronic hepatitis B patients. However, HBV reaction, even reverse back to HBeAg positive and clinical relapse could occur in some patients who achieved HBeAg seronconversion by interferon treatment. In this study, the long-term efficacy of interferon therapy in HBeAg positive patients achieved HBeAg seronconversion after interferon treatment and the factors associated with viral and clinical relapse will be observed.

Detailed description: HBeAg positive chronic hepatitis B patients achieved HBeAg seronconversion by interferon treatment will be enrolled and observed for 156 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe will be measured every 3 months during the observation period, liver function tests were performed every 3 months also. The liver ultrasonic examination would be taken every 3-6 months. The primary endpoint is sustained viral response, and secondary endpoints is HBV DNA reaction and clinical relapse defined as virla relapse with abnormal ALT during observation period.

Eligibility criteria: Inclusion Criteria:

* patients who achieved HBeAg seroconversion by interferon treatment.

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver

Primary outcomes:
measure: sustained viral response
timeFrame: 156 weeks
Secondary outcomes:
measure: HBV DNA reaction
timeFrame: 156 weeks
measure: clinical relapse
timeFrame: 156 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yao Xie
state: Beijing
Study officials:
References: