louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01759472: Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Provocation Test
Official title: Effect of Montelukast on Leukotriene Sensitive Asthma Detected by LTD4 Bronchial Provocation Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchial Asthma
Keywords: leukotriene
leukotriene receptor antagonist
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bronchial Asthma patients

Brief summary: To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in a specific sensitive to leukotriene population of asthma.

Hypothesis ：Monteluakst can better improve pre-challenge FEV1 from baseline in leukotriene-sensitive group than leukotriene-insensitive group.


Eligibility criteria: Inclusion Criteria:

1. Aged 15-60 years, male or female.
2. Mild to moderate persistent asthma.
3. Mini AQLQ score ≤6 or ACQ score ≥1.
4. Giving written informed consent.

Exclusion Criteria:

1. Current smoker or quitted smoking ≤12 months.
2. Significant allergen exposure.
3. Respiratory tract infection within 2 weeks before or during the study.
4. Cardiovascular disease.
5. History of malignant disease within the preceding 5 years.
6. And/or concomitant pulmonary disease.
7. Pregnant or breast-feed period.
8. Use of leukotrienes receptor antagonist within 5 days

Primary outcomes:
measure: whether there was improvement in pre-challenge FEV1%
timeFrame: from commencement of LTRA therapy to (7±2) days and (56±5) days
Secondary outcomes:
measure: whether there was improvement in post- treatment FENO
timeFrame: from commencement of LTRA therapy to (7±2) days and (56±5) days
Other outcomes:
measure: whether there was improvement in post- treatment PD20FEV1-MCH
timeFrame: from commencement of LTRA therapy to (7±2) days and (56±5) days
measure: whether there was improvement in post- treatment AQLQ symptom score
timeFrame: from commencement of LTRA therapy to (7±2) days and (56±5) days
measure: whether there was improvement in post- treatment ACT score
timeFrame: from commencement of LTRA therapy to (56±5) days
measure: whether there was a gradual decrease in weekly use of salbutamol
timeFrame: from commencement of LTRA therapy to (56±5) days
measure: improvement in weekly and monthly PEFR
timeFrame: from commencement of LTRA therapy to (56±5) days
measure: whether there was improvement in post- treatment PD20FEV1-LTD4
timeFrame: from commencement of LTRA therapy to (7±2) days and (56±5) days
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease, State Key Laboratory of Respiratory Disease
state: Guangdong
Study officials:
References:
Clinical trial NCT06487572: A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
Official title: A Phase 1, Open-label Study to Assess PK Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Risankizumab
ABBV-066
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
* Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion Criteria:

* Previous exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
* Intention to perform strenuous exercise to which the particpant is unaccustomed within one week prior to administration of first dose of study drug and during the study.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to approximately 140 days
measure: Maximum Observed Serum Concentration (Cmax) of Risankizumab
timeFrame: Up to approximately 140 days
measure: Time to Cmax (Tmax) of Risankizumab
timeFrame: Up to approximately 140 days
measure: Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab
timeFrame: Up to approximately Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology Of Miami /ID# 268219
state: Florida
city: Grayslake
country: United States
facility: Acpru /Id# 267057
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04629872: Fingolimod in Endovascular Treatment of Ischemic Stroke
Official title: Combinating Fingolimod With Endovascular Treatment in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stroke Inflammation
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in patients with acute ischemic stroke as a single therapy beyond 4.5 hours of disease onset, or in combination with alteplase within 4.5 hours of disease onset. This study aim to determine whether fingolimod enhance the action of endovascular treatment for acute ischemic stroke


Eligibility criteria: Inclusion Criteria:

* Patients presenting with anterior circulation acute ischaemic stroke who are eligible for mechanical thrombectomy commenced within 6-24 hours of stroke onset.
* Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.
* Patient's age is 18-80 years.
* Arterial occlusion on internal carotid artery proximal or middle cerebral artery
* Imaging inclusion criteria: infarct core volume between 15-70 mL

Exclusion Criteria:

* Pre-existing neurologic disability (a score greater than 2 on the mRS).
* Swallowing difficulties that would prevent administration of oral fingolimod.
* Patients with any history of bradyarrhythmia, atrioventricular block or current use of beta-blockers or verapamil.
* Patients with serious acute or chronic infection, or hepatic injury
* Concomitant use of antineoplastic, immunosuppressive or immune modulating therapies.
* Macular edema.

Primary outcomes:
measure: the grade of collateral circulation
timeFrame: Baseline (before endovascular treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
Study officials:
References:
Clinical trial NCT05821972: Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate
Official title: Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine to Induce Preoperative Sedation and Attenuate Emergence Agitation in Children Undergoing Cleft Palate Repair Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sedation
Emergence Delirium
Keywords: dexmedetomidine
Ketamine
Nebulization
Cleft palate
Sedation
Emergence delirium
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.

Detailed description: Cleft palate is a common congenital anomaly. The American cleft palate-craniofacial Association recommends that primary cleft palate repair should be ideally performed between 12-18 months after birth.

The pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. Pre-operative Anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. There is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. Ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.

Eligibility criteria: Inclusion Criteria:

* Patients with American Society of Anesthesiologists (ASA) physical status I \& II who will be scheduled for cleft palate repair surgeries

Exclusion Criteria:

* Parent refusal
* Allergy to the study drugs
* Suspected difficult airway
* Patients with endocrine, renal, hepatic, and cardiac pathology
* Psychiatric diseases
* Asthmatic patients.

Primary outcomes:
measure: Sedation level using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S)
timeFrame: Pre-operative
Secondary outcomes:
measure: Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)
timeFrame: Pre-operative
measure: Emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) scale
timeFrame: Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT06119672: Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment
Official title: Evaluation of the Efficacy of Supplementary Probiotic Capsules With Topical Clobetasol Propionate 0.05% in the Treatment of Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Oral Lichen Planus
Keywords: oral lichen planus
probiotics
clobetasol probionate
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2023-11-07
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups

-The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks.

Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment .

Patient's visits was at baseline, 2 weeks and 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients who are diagnosed with symptomatic lichen planus whether bullous erosive or erythematous oral lichen planus.
* Male or female patient with age range between 20-75 years old were included.
* medically free individuals

Exclusion Criteria:

* the use of systemic antibiotics, corticosteroids or immunosuppressive agents within four weeks prior to enrollment in the study.
* Pregnant females
* patients with history of systemic disorder affecting the immune system
* active liver diseases and cancer
* allergy or intolerance to probiotics.
* any other oral lesions

Primary outcomes:
measure: size wound
timeFrame: 0 , 2 weeks and 4 weeks
measure: Pain in oral cavity
timeFrame: 0 , 2 weeks and 4 weeks
Secondary outcomes:
measure: candidal load assessment
timeFrame: 0 and 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: yasmine kamal, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04393272: Digital Intelligent Assistant for Nursing Application
Official title: Digital Intelligent Assistant for Nursing Application Evaluation of 3-Dimensional Sensor Technology in Long Term Care and Acute Geriatrics. A Single Center Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty Syndrome
Fall in Nursing Home
Dementia
Delirium in Old Age
Incontinence, Urinary
Incontinence Bowel
Keywords: 3D sensors
falls detection
toileting algorithm
Lead sponsor: Geriatrische Klinik St. Gallen
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 25
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Due to the observationa design, we will have no control group. All persons admitted to the rooms equipped with this novel technology are asked to participate.

Brief summary: This is an observational study that intends to compare falls or fall-risk related alarms derived from a three-dimensional sensor system with the clinical reality definded by attending nurses.

Detailed description: Three dimensional sensor technology (3DS) is available for fall detection and fall prevention (e.g. unwanted getting up in persons with risks for frequent falls) in several institutions in Europe and Switzerland. 3DS are capable to analyze completely anonymized data and alert nurses towards a dangerous (fall) or potentially dangerous (getting out of bed) event during day- and nighttime. Multi-sensor technology has been applied to assess activities of daily living in persons cognitive problems living at home. To our knowledge, 3DS technology has not been examined as part of a structured clinical protocol. In addition, the combination of two digital technologies (3DS and a server based software) as an integrative platform could help to develop algorithms to analyze complex human activities such as using a toilet. Automated analyses of such complex activities have the potential to support nursing staff in the future.

Eligibility criteria: Inclusion criteria Informed consent given by person or caregiver Patients admitted

* with or without cognitive decline for any reason
* with acute and/or chronic conditions
* after any kind of surgery

Exclusion Criteria:

1. For Falls assessment by 3D sensors:

   • Based on the multifactorial risk for falls there are no exclusion criteria for falls assessment
2. For the development of toileting algorithm:

   * severe urine or fecal incontinence
   * permanent indwelling urinary catheter
   * permanent urinary or bowel stoma

Primary outcomes:
measure: Falls detection rate
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
measure: Assessment of toileting
timeFrame: Through study completion, an average of 6 months
Locations:
city: Sankt Gallen
country: Switzerland
facility: Geriatrische Klinik
state: SG
Study officials:
References:
Clinical trial NCT06991972: Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients
Official title: PUNCTURE TO REPIGMENT: A COMPARATIVE ANALYSIS OF NEEDLING VS MICRONEEDLING ALONG WITH NBUVB IN TREATMENT OF NON-SEGMENTAL VITILIGO
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Vitiligo
Non-segmental Vitiligo
Keywords: vitiligo
needling
microneedling
Lead sponsor: Khyber Teaching Hospital
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to compare the efficacy of needling versus microneedling, both followed by narrowband UVB therapy, in achieving repigmentation in patients with localized stable non-segmental vitiligo.

Detailed description: The study will enroll 80 patients aged 15-60 years with localized stable vitiligo. Participants will be randomized into two groups: one receiving needling and the other microneedling, each followed by NBUVB therapy. The primary outcome is the percentage of repigmentation at 12 weeks, assessed through digital planimetry and standardized clinical photography. Secondary outcomes include adverse effects such as erythema, post-inflammatory hyperpigmentation, infection, and scarring.

Eligibility criteria: Inclusion Criteria:

* Both male and female
* Age 15-60 years
* Patients having vitiligo for more than 1 year

Exclusion Criteria:

* Patients with tendency of keloid formation or hypertrophic scarring
* Patients with any bleeding disorder, coagulation defect or using anti platelets
* Any local infection at the treatment site
* Patients who had received systemic therapy in last 6 months

Primary outcomes:
measure: Treatment efficacy
timeFrame: 12 weeks
Secondary outcomes:
measure: Adverse effects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Teaching Hospital
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Khyber Teaching Hospital
name: Huma Gul Doctor, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02339272: Study of Synapsis and Recombination in Male Meiosis and the Implications in Infertility
Official title: Study of Synapsis and Recombination in Male Meiosis and the Implications in Infertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abnormal Spermatogenesis
Azoospermia
Keywords: meiosis
synapsis
recombination
sperm aneuploidy
Lead sponsor: Igenomix
Sponsor class: INDUSTRY
Collaborators: name: Instituto Universitario IVI
First posted: 2015-01-15
Enrollment: 50
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Testicular biopsies from NOA patients and a control group from post-vasectomized (OA) patients.

Brief summary: The aim of this study was to assess meiotic recombination in primary spermatocytes, synaptonemal complex length and the correlation with chromosomal abnormalities in testicular spermatozoa from infertile men with idiopathic non-obstructive azoospermia (NOA).

Detailed description: During the first meiotic division in spermatogenesis there are two critical events. First, synapsis between homologous chromosomes and formation of the synaptonemal complex (SC), which regulates sister chromatid cohesion and provides the template for localization of recombination machinery proteins. Secondly, recombination between homologous chromosomes, which is essential for the correct segregation. Errors during these two processes may induce incorrect segregation of chromosomes and are a major cause of gamete aneuploidy. The aim of this study was to assess meiotic recombination in primary spermatocytes, synaptonemal complex length and the correlation with chromosomal abnormalities in testicular spermatozoa from infertile men with idiopathic non-obstructive azoospermia (NOA). Prospective cohort study to assess meiotic progression, total length of SC, frequency of recombination and sperm aneuploidy in samples obtained from testicular biopsies from NOA patients. The study group was compared with a control group from post-vasectomized (OA) patients. Immunocytogenetics with SCYP3, CREST and MLH1 antibodies for meiotic progression, SC length, and recombination. Fluorescence in situ Hybridization (FISH) for chromosomes 1, 4, 6, 13, 16, 18, 21, 22 in primary spermatocytes and chromosomes 13, 18, 21, X, Y on sperm. MicroMeasure 3.3 program was used for SC length.

Eligibility criteria: Inclusion Criteria:

* NOA patients undergoing ICSI with testicular sperm
* OA post-vasectomized patients undergoing ICSI with testicular sperm

Exclusion Criteria:

* Abnormal Karyotype

Primary outcomes:
measure: Meiotic recombination
timeFrame: once
Secondary outcomes:
measure: Sperm aneuploidy
timeFrame: once
Other outcomes:
Locations:
city: Paterna
country: Spain
facility: Igenomix
state: Valencia
Study officials:
affiliation: Lab Director
name: Carmen Rubio, PhD
role: PRINCIPAL_INVESTIGATOR
References: