louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02294097: Protocol-Specified Modification of Immunosuppression Directed to Protocol Biopsy in Kidney Transplantation
Official title: The Outcomes of Protocol-Specified Modification of Immunosuppression Directed to Histological Diagnosis by Surveillance Protocol Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surveillance Protocol Biopsy
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The risk-benefit of surveillance-protocol biopsy (SPBx) in kidney transplantation remains unclear. The study aims to compare outcomes of recipients with SPBx approach to recipients with standard approach which allograft biopsy was performed only when indicated.

Detailed description: The present randomized-controlled trial in kidney transplant patients aims to compare the outcomes and complications between who underwent immunosuppessive drug modification under surveillance-protocol biopsy and who underwent immunosuppressive drug modification following tough level only.

Eligibility criteria: Inclusion Criteria:

* All kidney transplant recipients underwent transplantation at Chulalongkorn University

Exclusion Criteria:

* Pregnancy
* Recipients who cannot withhold aspirin, clopidogrel, warfarin, etc.
* Non-cooperated recipients

Primary outcomes:
measure: Renal function
timeFrame: 24 months
Secondary outcomes:
measure: Renal pathology
timeFrame: 24 months
measure: Complications
timeFrame: immediate, 1 month
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Wiwat Chancharoenthana, MD.,MSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992497: Cesarean Section Study
Official title: Effect,Tolerance and Safety of a Supplementation With a Probiotic in Healthy Newborn Term Infants Born by Cesarean Section Over a 12 Months Period Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Atopic Dermatitis
Keywords: Cesarean section, probiotic, formula fed, gut microbiota
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 721
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the formula-fed and in the breastfed feeding groups.


Eligibility criteria: Inclusion Criteria:

* written informed consent must be obtained from legal guardian(s) prior to randomization or any study related procedures
* healthy newborns
* born by Cesarean section
* singleton birth
* Age at enrollment in the study \< 24h
* birth weight ≥ 2500g and ≤ 4300g
* gestational age ≥ 37 weeks and ≤ 42 weeks

Exclusion Criteria:

* congenital diseases or malformations that may inhibit growth
* prenatal and/or postnatal diseases
* parents are expected to have difficulty complying with the feeding regime
* planned re-admittance to the hospital in the first 14 days of life
* antibiotic treatment at the time of enrollment in the study

Primary outcomes:
measure: Number of diarrhea episodes between a probiotic vs. placebo
timeFrame: 12 months
Secondary outcomes:
measure: Diarrhea duration between a probiotic vs. placebo
timeFrame: 12 months
Other outcomes:
Locations:
city: Potsdam
country: Germany
facility: Klinikum Ernst v. Bergmann GmbH
Study officials:
References:
Clinical trial NCT00775697: Montelukast in Children With Wheezing
Official title: Montelukast Effects on Pulmonary Function in Children With Wheezing Aged Less Than 2 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Wheezing
Keywords: wheezing
children
montelukast
bronchodilators
lung function
Rint
Lead sponsor: Universita di Verona
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Policlinico
First posted: 2008-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study children with recurrent wheezing (\>/= 2 episodes in the last 6 months)and aged less than 2 years will be enrolled as outpatients. They will undergo lung function evaluation by Rint and by assessment of the flow curves at baseline and after 4 weeks of treatment with Montelukast 4 mg/day. Symptom dairies will be filled by parents during the study period.

Detailed description: Patients aged less than 2 years with recurrent wheezing. At visit 1 patients with symptoms will be enrolled and the study explained. They will return home with bronchodilator therapy.

Within 1 week they will return for visit 2 to start a run-in period with bronchodilators prn and they will fill dairies with symptoms and drug use. Skin prick test will be evaluated at that time.

At visit 3 after 1 week of the run-in period they will start therapy with Montelukast 4 mg for 4 weeks, using bronchodilators prn and filling diaries.

The final visit will be after four weeks with re-evaluation of the lung function

Eligibility criteria: Inclusion Criteria:

* Age between 6-24 months
* Patients with recurrent wheezing (at least 2 episodes in the last 6 months)
* Patients with symptoms at enrollment

Exclusion Criteria:

* Chronic respiratory diseases (cystic fibrosis, chronic lung disease) symptoms at visit 1 that require hospital admission

Primary outcomes:
measure: Lung function test (flow and resistance)
timeFrame: 4 weeks
Secondary outcomes:
measure: Bronchodilator use Dairy symptoms
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Clinica Pediatrica Universita' di Verona Policlinico GB Rossi
Study officials:
affiliation: Universita di Verona
name: Attilio L Boner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05109897: Influencing Factors on Gait Variability in PD
Official title: Influencing Factors and Improving Strategy on Gait Variability in People With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Parkinson's disease, Gait variability
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Parkinson's disease

Brief summary: The principal motor features of Parkinson's disease (PD) include rigidity, tremor, bradykinesia, and postural instability. These motor deficits might cause gait dysfunction including reduced gait velocity, stride length, arm swing, and increased gait variability. Among these, increase in gait variability increased fall risk and served as a marker of disease progression. Previous studies reported that some factors might influence gait variability. However, which one contributes most has not yet been verified. Therefore, the purpose of the present study is to identify the more related influencing factors on gait variability in people with PD.


Eligibility criteria: Inclusion Criteria:

* Idiopathic PD
* Hoehn and Yahr stages I through III
* Ability to stand and walk 5 m independently with or without any walking aids
* Stable medication usage

Exclusion Criteria:

* Unstable medical conditions
* Any neurological, cardiopulmonary or orthopedic problem/diseases that may interfere with participating the study

Primary outcomes:
measure: Gait variability
timeFrame: 10 minutes
measure: Walking speed
timeFrame: 10 minutes
measure: Sensory organization test
timeFrame: 20 minutes
measure: Part III of the Unified Parkinson's Disease Rating Scale
timeFrame: 20 minutes
measure: Tinetti Balance Scale
timeFrame: 10 minutes
measure: New freezing of gait questionnaire
timeFrame: 15 minutes
measure: Montreal Cognitive Assessment
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Study officials:
References:
Clinical trial NCT00689897: Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea
Official title: Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Dysmenorrhea
Keywords: Primary Dysmenorrhea
Deqi
acupuncture
psychology
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Fifth Hospital of Wuhan
First posted: 2008-06-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the associations between deqi, the effects of acupuncture and personality in primary dysmenorrhea and to characterize the nature of the deqi phenomenon on terms of the prevalence of sensations as well as the uniqueness of the sensations underlying the deqi experiment.

Detailed description: The mechanism, by which acupuncture works is not yet clear, therefore there is no unequivocal consensus about styles and sensations of acupuncture. whether psychological factor has influences on the effects of acupuncture? This study will adopt international practices such as visual analogue scale (VAS) to objective evaluation. The confident degree, feeling degree for acupuncture and pain intensity were evaluated by the patient with VAS, and the pain VAS scores before and after acupuncture were recorded as the indexes for assessment of the therapeutic effect.

Eligibility criteria: Inclusion Criteria:

1. Female, age between 18 and 30 years old, who had regular menstrual cycles (28-33 days);
2. Meeting diagnostic criteria for primary dysmenorrhea, having moderate to severe symptoms when unmedicated, and eligible for care through the military health system.

Exclusion Criteria:

1. Secondary dysmenorrhea;
2. Women with systemic disease, or hormonal, psychiatric or gynecologic disorders, or substance abuse;
3. Pregnant or trying to conceive, using oral contraceptives, smoker, breast-feeding.

Primary outcomes:
measure: Visual Analogue Scale for pain intensity of primary dysmenorrhea
timeFrame: 90 days after onset
Secondary outcomes:
measure: average duration (hours) of pain
timeFrame: 90 days after onset
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Institute of Integrated Traditional Chinese and Western Medicine
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wei Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00697697: A Study of 2 Doses of MAP0010 in Asthmatic Children
Official title: A Randomized, Double-blind, Active-controlled, Phase 3 Extension Study Investigating the Safety and Efficacy Over 40 Weeks of 2 Doses of MAP0010 in Asthmatic Children (12 Months to 8 Years Old at the Time of Enrollment Into the MAP0010-CL-P301 Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
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: 2008-06-16
Enrollment: 192
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 of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.


Eligibility criteria: Inclusion Criteria:

* Completed 12 weeks of treatment in the MAP0010-CL-P301 study.
* Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate.

Exclusion Criteria:

* Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.

Primary outcomes:
measure: Number of Patients With Treatment Emergent Adverse Events Related to Study Drug
timeFrame: 40 weeks
measure: Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MAP Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01738997: Endoscopical Dilation of Benign Esophageal Strictures
Official title: Endoscopical Dilation of Benign Esophageal Strictures - a Randomized, Clinical Trial, Comparing Two Different Inflation Times.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: Benign
Esophageal strictures
Esophagus
Balloon Dilation
Lead sponsor: University Hospital, Umeå
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Boston Scientific Corporation
First posted: 2012-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although balloon dilatation is the primary treatment for benign dysphagia, information about the optimal inflation time is lacking. The aim of the current pilot study was to compare 10 seconds inflation time, with 2 minutes inflation time, regarding the efficacy


Eligibility criteria: Inclusion Criteria:

* Symptomatic dysphagia with an endoscopic picture suggestive of a benign disease

Exclusion Criteria:

* Suspicion of achalasia or malignancy. If the patients needed more than 3 dilations the first month this was also a considered an exclusion criterion

Primary outcomes:
measure: Relief from dysphagia
timeFrame: 1 year from dilation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06529497: Racecadotril Versus Standard Treatment in Decreasing the Duration of Acute Diarrhoea in Children
Official title: Efficacy of Racecadotril in Addition to Standard Treatment i in Decreasing the Duration of Acute Diarrhoea in Children as Compared to Standard of Treatment Alone
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Diarrhoea
Keywords: Stool
Diarrhoea
Paediatrics
Lead sponsor: Liaquat National Hospital & Medical College
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 260
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per WHO classification. The study's outcome variables are stool frequency, measured by the total number of stools passed during 24 and 48 hours from the initiation of treatment, and hospital duration, measured by the total duration of hospital stay in hours. The null hypothesis states that racecadotril combined with standard treatment has no effect on reducing the mean number of stools passed during 48 hours compared to standard treatment alone in pediatric patients with acute watery diarrhea, while the alternate hypothesis suggests that racecadotril combined with standard treatment will significantly reduce the mean number of stools passed during 48 hours compared to standard treatment alone in these patients.


Eligibility criteria: Inclusion Criteria:

* Hospitalized Patients with acute watery diarrhea of both genders who are

  1. Age: 03 months to 05 years
  2. Present in first 24 hours of onset of disease.

     Exclusion Criteria:

  <!-- -->

  1. Parenteral Diarrhea
  2. Chronic Diarrhea like Coeliac disease, Lactose intolerance
  3. Mal-absorption Syndromes
  4. Diarrhea related to food poisoning, dysentery as suggested by history
  5. Severe dehydration patents who are vitally unstable.
  6. Diarrhea associated with measles.
  7. Persistent vomiting
  8. Abdominal distention
  9. Patients allergic to racecadotril
  10. Patients managed before enrolled to study

Primary outcomes:
measure: Stool frequency
timeFrame: 48 hours
Secondary outcomes:
measure: Hospital Duration
timeFrame: 48 Hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01657097: Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge
Official title: Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge. Impact on Bronchial Hyperresponsiveness and the Effect of Intranasal Corticosteroid Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Asthma
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2012-08-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study was performed to gain information on this inflammation, including effect of intranasal corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma.

The study was randomised, placebo-controlled double-blind in patients, monoallergic to grasspollen, presenting symptoms of rhinitis and asthma during season.

Treatment,ie intranasal corticosteroid or placebo, were given four weeks. After two weeks of treatment intranasal allergen challenge was performed. Measurements were performed during the full study period.

The study was performed out of pollen season.


Eligibility criteria: Inclusion Criteria:

* monoallergy to grass
* symptoms of allergic rhinitis for at least the two most recent grasspollen seasons
* asthma symptoms of asthma for at least two of the four most recent grasspollen seasons
* age 18 or older

Exclusion Criteria:

* pregnancy or lactation
* fertile women, not sterilised or using sufficient anticonception
* Corticosteroid treatment (parenteral, oral, inhaled or intranasal) within two months prior to enrolment
* Any other disease, condition or treatment, which to the discretion of the investigator has the potential to interfere with study results

Primary outcomes:
measure: Serum Eosinophil Cationic Protein (ECP)
timeFrame: 1 month
Secondary outcomes:
measure: Serum Eosinophil Peroxidase (EPO)
timeFrame: 1 month
measure: Nasal lavage Eosinophil Cationic Protein (ECP)
timeFrame: 1 month
measure: Nasal lavage Eosinophil Peroxidase (EPO)
timeFrame: 1 month
measure: Blood Eosinophils
timeFrame: 1 month
Other outcomes:
measure: Bronchial metacholine challenge
timeFrame: 1 month
measure: Acoustic rhinometry
timeFrame: 1 month
measure: Spirometry (Forced Expiratory Volume 1 second (FEV-1))
timeFrame: 1 month
measure: Nasal symptom score
timeFrame: 1 month
measure: Asthma symptom score
timeFrame: 1 month
Locations:
city: Aarhus
country: Denmark
facility: Department of Respiratory Diseases, Aarhus University Hospital
Study officials:
affiliation: Department of Respiratory Diseases, Aarhus University Hospital
name: Ronald Dahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02682797: Optical Coherence Tomography Evaluation of Retinoschisis and Retinal Detachment
Official title: Use of Spectral Domain Optical Coherence Tomography to Differentiate and Follow-up Senile Retinoschisis and Retinal Detachment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinoschisis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 consecutive patients will be recruited for this study; 15 with Retinoschisis and 15 with retinal detachment

Brief summary: Retinoschisis is usually a rare self-limited disease and seldom shows progression. There a splitting of the neurosensory retina occurs usually in the inferior temporal. Patients usually have good visual acuity and are asymptomatic. Combination of an inner and outer layer hole is considered high risk factor for development of a schisis detachment. The most important differential diagnosis is an retinal detachment, since if misdiagnosed unnecessary treatment is provided. In clinical examination, both can appear very thin and transparent.

Therefore exact diagnosis of retinoschisis and retinal detachment has to be assessed and regular follow-up controls have to be conducted for sufficient recognition of progression.


Eligibility criteria: Inclusion Criteria:

* Male or female, at least 18 years of age.
* Ophthalmoscopic evidence of RS or RD
* Written informed consent has been obtained.

Exclusion Criteria:

* Progression of retinal detachment or retinoschisis requiring surgical treatment
* Contraindication to pupil dilation, known allergy.

Primary outcomes:
measure: Morphological findings in retinoschisis or retinal detachment in optical coherence tomography scans during follow-up
timeFrame: Baseline
measure: Change or progression of disease measured in optical coherence tomography
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology, Medical University of Vienna, Austria
Study officials:
References: