louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00569192: A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthmatic children
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
First posted: 2007-12-07
Enrollment: 360
Sex: ALL
Minimum age (years): 12
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.


Eligibility criteria: Inclusion Criteria:

* Male or female asthmatic children with mild to moderate persistent asthma.
* 12 months to 8 years of age.
* For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
* For infants age 12 to \<48 months old: 2 or more wheezing episodes in past 12 months which lasted \> 1 day and affected sleep.
* AND with at least one major or two minor risk factors.

Exclusion Criteria:

* Any other significant childhood illness/abnormality or chronic lung disease
* Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
* Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
* Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
* Any use of oral corticosteroids within 30 days of screening or prolonged use (\>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

Primary outcomes:
measure: Change From Baseline in Daytime Composite Symptom Score
timeFrame: baseline, week 12
measure: Change From Baseline in Nighttime Composite Symptom Score
timeFrame: baseline, week 12
Secondary outcomes:
measure: Change From Baseline in FEV1% Predicted
timeFrame: baseline, week 12
measure: Change From Baseline in PEF
timeFrame: baseline, week 12
measure: Change From Baseline in Daytime Individual Symptom Scores
timeFrame: baseline, week 12
measure: Change From Baseline in Nighttime Individual Symptom Scores
timeFrame: baseline, week 12
Other outcomes:
Locations:
Study officials:
affiliation: MAP Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05749692: The Impact of COVID-19 Infection on the Symptoms of Functional Dyspepsia
Official title: The Impact of COVID-19 Infection on the Symptoms of Functional Dyspepsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyspepsia
Keywords: Functional Dyspepsia
COVID-19
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≥ 18 years old who met broad criteria of dyspepsia were eligible for our study before infection.

Brief summary: Although respiratory symptoms were predominant in patients infected with COVID-19, gastrointestinal symptoms were always reported in about 10% patients. Previous studies demonstrated that the SARS-CoV-2 virus still persists in stool samples for a long time after initial infection. Moreover, some patients had a longer duration of COVID-19-related gastrointestinal symptoms, which was defined as "post-acute COVID-19 syndrome".

Previous studies have shown that functional gastrointestinal disorders may occur after acute gastroenteritis. Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders. FD was reported to be correlated with multiple pathophysiological mechanisms, including GI bacterial imbalance, disordered gut microbiota, and disturbed barrier and immune function. It is unknown whether COVID-19 infection could exacerbate the symptoms of FD. Therefore, we followed up a group of FD patients before and after COVID-19 and investigate the impact of COVID-19 infection on the symptoms of FD.


Eligibility criteria: Inclusion Criteria:

1. aged ≥18 years old
2. Patients who met broad criteria of dyspepsia before infection

Exclusion Criteria:

1. organ failure defined by Marshall standard
2. severe psychiatric illnesses
3. suspected or identified bowel obstruction
4. known malignancy
5. pregnancy or lactation
6. unable to provide consent

Primary outcomes:
measure: a score of 1 or 2 (extremely worse) on a 7-Likert scale assessing dyspepsia symptom change
timeFrame: 1month, 3 months, 6 months
Secondary outcomes:
measure: Global Overall Symptom score (GOSS)
timeFrame: 1month, 3 months, 6 months
measure: subtypes of functional dyspepsia
timeFrame: 6 months
measure: self-reported severity of symptoms by patients
timeFrame: 1month, 3 months, 6 months
measure: Other gastrointestinal symptoms
timeFrame: 1month, 3 months, 6 months
measure: Short Form of Nepean Dyspepsia Index (SF-NDI)
timeFrame: 1month, 3 months, 6 months
measure: Hospital anxiety and depression scale
timeFrame: 1month, 3 months, 6 months
Other outcomes:
Locations:
city: Xian
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
Clinical trial NCT01046292: Effect of Ginkgo Biloba Special Extract LI 1370 on Dual-tasking in Patients With MCI
Official title: Effect of Ginkgo Biloba Special Extract LI 1370 on Dual-tasking in Patients With MCI: a Randomized, Double-blind, Placebo-controlled Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mild Cognitive Impairment
Keywords: Gait, Ginkgo biloba, mild cognitive impairment
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of Ginkgo Biloba Extract (GBE) in executive function-impaired Mild Cognitive Impairment (MCI) patients by assessing gait while walking alone as well as under differing dual-task conditions.

The primary endpoint in the evaluation of GBE efficacy is gait speed. The secondary endpoint is cycle time variability under dual-task conditions.


Eligibility criteria: Inclusion Criteria:

* Age 50-85 years
* Swiss German or German speaker
* Completed elementary school
* Impaired executive function (gait speed reduction ≥ 10% under dual-task as compared to normal walking)
* No dementia according to International Classifications of Diseases (ICD)-10 and Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV.
* Cognitive decline (self/informant report or objective task)
* Preserved basic activities of daily living and minimal impairment in complex instrumental functions
* Written informed consent and nihil obstat

Exclusion Criteria:

* Current drug treatment with Warfarin-like drugs (Coumarins or Clopidogrel), however, acetylsalicylic acid 100mg and 300mg is permitted
* Current intake of GBE or during the last 6 months
* Known hypersensitivity to GBE or its constituents
* Regular intake of antipsychotic, anxiolytic or sedative drugs(allowed if clinically stable for at least the past 3 months while under treatment)
* Concomitant gait-relevant disorders: severe cardio/pulmonary/cerebron -vascular disorders, bleeding diathesis, polyneuropathy and severe orthopedic disorders, organic cerebral disease epilepsy, low vision
* Severe medical conditions (e.g. chronic renal insufficiency, severe hepatic disorders,cardio-vascular disease, uncontrolled hypertension, peptic ulcer, malignoma)
* Participation in another clinical intervention study within the last 2 months
* Use of walking aid
* Normal walking speed is \< 100cm/s

Primary outcomes:
measure: gait speed
timeFrame: baseline, 3, 6, 12 months
Secondary outcomes:
measure: cycle time variability
timeFrame: baseline, 3, 6, 12 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Basel University Hospital, Basel Mobility Center
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Reto W Kressig, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07022392: Feasibility and Acceptability of the Technology Based Enhanced Gender Support Platform Implementation With Parents
Official title: Feasibility and Acceptability of the Technology Based Enhanced Gender Support Platform Implementation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parents
Usability
Keywords: parents
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All parents and caregivers who agree to participate in the study will receive the same intervention- the TEGS platform. Each will complete surveys at baseline, 1 mo and 3mo after getting access to the platform.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a small pilot feasibility and acceptability study of implementing a Technology-Enhanced Gender Support (TEGS) platform with parents and caregivers. Parents and caregivers who consent to participate will complete an electronic survey at baseline. They will then receive access to the TEGS platform and complete follow up surveys 1 mo and 3 mo after. Each participant will also be given the option to participate in an exit interview.


Eligibility criteria: Inclusion Criteria:

* Parent of a gender diverse youth aged 8-17
* Has access to the internet
* Can speak or read English

Exclusion Criteria:

* Not a parent of a gender diverse youth aged 8-17
* No access to the internet
* Cannot speak or read in English

Primary outcomes:
measure: System Usability Scale
timeFrame: 1 month and 3 months
Secondary outcomes:
measure: TransFATE scale
timeFrame: Baseline, 1 month, 3 month
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References:
Clinical trial NCT00405392: Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
Official title: An Open-label, Multi-centre, Randomized Study to Investigate Patient Preference on Dosing in the Once-monthly Ibandronate and the Once-weekly Risedronate in Korean Women With Postmenopausal Osteoporosis. A Six-month, Two-sequence, and Two Period Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis, Postmenopausal
Keywords: risedronate
Ibandronate
preference
Osteoporosis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-30
Enrollment: 365
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized open label, multi-centre study for Korean women with postmenopausal osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or the once-weekly dosing of risedronate.

Eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly regimen.

Treatment period consists of 3 month with ibandronate 150mg and additional 12 week with risedronate 35 mg or vice versa.

After taking the first interventional medicine for 3 months or 12 weeks completely, a subject changes the treatment arm. There is no washout period.


Eligibility criteria: Inclusion Criteria:

* Women with postmenopausal osteoporosis diagnosed by DXA scanning, defined by T-score of -2.5 SD at spine or femur.
* Patients who have never received bisphosphonates therapy (bisphosphonates naive)

Exclusion Criteria:

* Inability to stand or sit in the upright position for at least 60 minutes;
* Hypersensitivity to any component of risedronate and ibandronate;
* Administration of any investigational drug within 30 days preceding the first dose of the study drug;
* Patient has been on hormone (estrogen) replacement therapy or other osteoporosis medication (e.g. SERMS and calcitonin) within the previous 3 months.
* Patient has been on systemic corticosteroids therapy for more than 1 month within the past year.
* Other bone disease except osteoporosis
* Current medical history of uncontrolled major upper GI disease

Primary outcomes:
measure: Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate
timeFrame: Visit 4 (Week 24)
Secondary outcomes:
measure: Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration
timeFrame: Visit 4 (Week 24)
measure: Mean Percent Change of Serum C-terminal Telopeptide (CTx) From Baseline to Visit 3 for Once-monthly Dosing of Ibandronate & Once-weekly Dosing of Risedronate
timeFrame: Baseline (Week 0) and Visit 3 (Week 12)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00864292: Predictors of Neuro-cognitive Decline and Survival in HIV-infected Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AIDS
Dementia
Lead sponsor: SEARCH Research Foundation
Sponsor class: OTHER
Collaborators: name: Thai Red Cross AIDS Research Centre
First posted: 2009-03-18
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Patients will be followed every 6 months for a total of 5 visits (Month 0, 6, 12, 18 and 24). The first visit is the screening and entry visit which can occur at any time after the subject finishes SEARCH 001 study but preferably it should occur approximately 6 months after SEARCH 001 study completion.

At each visit, patients will undergo the following

1. Assessment of function including activity of daily living questionnaire
2. History of medical illnesses, medication history
3. Neurological examination: All patients will have a neurological evaluation and neuropsychological evaluation to characterize neurocognitive and neurological status. (It is possible that patients within the non-dementia group will meet criteria for dementia after close testing is completed).
4. Neuropsychological assessment:
5. Thai Depression Inventory.
6. HIV viral load and storage of blood for proviral DNA level

Final outcome assessment based on all available data. If possible, it is intended that these diagnoses will be determined through monthly VTC conference calls with UH investigators. This consensus conference will include the Thai investigators, the UH neurologist, the UH neuropsychologist and the UH principal investigators.


Eligibility criteria: Inclusion Criteria:

* All patients who have completed the SEARCH 001 study are eligible to enroll in this SEARCH 001.1 study provided that they understand and voluntarily sign the informed consent form.

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: South East Asia Research Collaboration with Hawaii
Study officials:
affiliation: SEARCH Research Foundation
name: Jintanat Ananworanich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06542692: Effect of Whole Body Vibration Therapy on Pain, Muscle Strength, Balance and Quality of Life in Knee Osteoarthritis
Official title: Effect of Whole Body Vibration Therapy on Pain, Muscle Strength, Balance and Quality of Life in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis
Keywords: vibration
whole body vibration
Osteoarthritis
Osteoarthritis, Knee
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 42
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effects of whole body vibration therapy on knee osteoarthritis. While the participants did static exercise in one group, whole body vibration therapy was applied during static exercise in another group. As a result of 15 sessions of treatment in both groups, the effects on pain, muscle strength, balance and quality of life were compared.


Eligibility criteria: Inclusion Criteria:

* Those who were diagnosed with primary symptomatic knee OA according to ACR criteria,Ages between 35 and 70, Body mass index (BMI) ⩽35, Grade II or III according to Kellgren \&amp; Lawrence scale, Patients with persistent symptoms such as pain and stiffness for at least 3 months were included.

Exclusion Criteria:

* Those who have had knee surgery before, Those with central nervous system disease (especially epilepsy and serious psychotic disorders), those with a history of acute arthritis, Those with a history of DVT in the last 24 weeks, Those with advanced lung or heart disease (COPD and heart failure), Those diagnosed with inflammatory rheumatic diseases (Rheumatoid arthritis, Spondyloarthropathy, etc.), Patients diagnosed with advanced stage cancer were excluded from the study.

Primary outcomes:
measure: visual analog scala
timeFrame: 3 weeks
measure: Womac
timeFrame: 3 weeks
measure: muscle strength
timeFrame: 3 weeks
measure: Biodex
timeFrame: 3 weeks
measure: Short Form 36
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
References:
Clinical trial NCT02992392: Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
Official title: Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Keywords: Tear film
Lipid layer
Liposic
Tears Naturale Forte
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been developed in which phospholipid liposomes are delivered to the tear film via the surface of the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte application on the lipid and stability of the tear film in dry eye patients.


Eligibility criteria: Inclusion Criteria:

* Minimum age of 20 years(range from 20 year to 25 years)
* The value of OSDI is over 12
* NBUT is less 5 seconds
* Schirmer 1 test is less 10mm
* The basical lipid layer grade is 1-2

Exclusion Criteria:

* Any corneal,conjunctival, or eyelid abnormalities; conjunctivitis; current ocular infection; photophobia that may cause reflex tearing or difficulty in evaluating the patient's lipid layer;
* Known allergic sensitivity to any of the ingredients in Liposic or Tears Naturale Forte

Primary outcomes:
measure: scale of Schirmer I test
timeFrame: up to 3 months after tear substitutes apply
measure: scale of corneal fluorescein staining
timeFrame: up to 3 months after tear substitutes apply
measure: scale of noninvasive tear breakup time
timeFrame: up to 3 months after tear substitutes apply
measure: scale of tear meniscus height
timeFrame: up to 3 months after tear substitutes apply
measure: lipid layer grade
timeFrame: up to 3 months after tear substitutes apply
measure: questionnaire of ocular surface disease index
timeFrame: up to 3 months after tear substitutes apply
Secondary outcomes:
measure: subjective comfort
timeFrame: up to 3 months after tear substitutes apply
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University
state: Hainan
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xingwu Zhong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01804192: Is Acupoints Sensation Necessary for Acu-TENS to Elicit Physiological Changes in Healthy Subjects?
Official title: Is Acupoints Sensation Necessary for Acu-TENS to Elicit Physiological Changes in Healthy Subjects?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autonomic Nervous System Disorder
Keywords: Acu-TENS
MAP
HR
HRV
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Traditional Chinese Medicine (TCM) practitioners believe that health can be maintained if the body has a balanced ying-yang or the qi flows in correct strength and quality along the meridians.Stimulation of the acupoints such as by acupuncture can awaken and modulate qi in the channels and is able to regulate and restore yin-yang balance.However, there are some drawbacks associated with acupuncture which may limit its applications. These include transmission of infectious disease, pneumothorax and other problems associated with organ punctures, cardiac tamponade, and broken needles with remnants migrating to other locations.Studies have shown that when TENS is applied over acupoints (Acu-TENS), it is effective in reducing dyspnoea in patients with chronic obstructive pulmonary disease,facilitate early haemodynamic recovery after open-heart surgery,relieve labor pain,increase in blood β-endorphin level,reduce blood pressure changes in normal healthy subjects and decrease airway resistance.Despite these promising results, how Acu-TENS works still remain unclear.This study aimed to investigate the effects of Acu-TENS over Hegu (LI4) and Quichi (LI4) on the autonomic nervous system activities and to investigate whether the subject could experience distinct sensation as deqi.

Detailed description: Eligibility criteria: Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese.

Outcome Measures: Heart rate, Mean arterial blood pressure, Heart rate variability

Eligibility criteria: Inclusion Criteria:

* Normal healthy subjects who were naïve to Acu-TENS and able to read Chinese were recruited for study

Exclusion Criteria:

* history of cardiopulmonary, neurological and psychologic disorders or they required taking drugs within one week that might affect the cardiovascular and neurological status

Primary outcomes:
measure: Heart rate variability
timeFrame: One month after the intervention
Secondary outcomes:
measure: Heart rate
timeFrame: One month after the study
Other outcomes:
measure: Mean Blood pressure
timeFrame: One month afterwards
Locations:
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
state: Hong Kong
Study officials:
affiliation: The Queen Elizabeth Hospital
name: Tai Wai David Yu, MSc
role: PRINCIPAL_INVESTIGATOR
References: