louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04278248: Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above
Official title: A Randomized, Blinded, Parallel Controlled, Phase Ⅲ Clinical Trial to Evaluate Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia, Pneumococcal
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-02-20
Enrollment: 1940
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate Immunogenicity and safety of 23-Valent Pneumococcal Polysaccharide Vaccine in healthy volunteers aged 2 Years and above.


Eligibility criteria: Inclusion Criteria:

* 2 years old and above healthy people.
* Subject or legal representative who consent and has signed written informed consent.
* Subject or legal representative who is able to comply with all study procedures.
* Subject who didn't vaccinate pneumococcal vaccines and did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
* Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

* History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
* Allergic history after vaccination.
* Known allergy to any component of the test vaccine（the test vaccine mainly contains 23 types of pneumococcal polysaccharide and PBS buffer）
* Subjects who diagnosis of thrombocytopenia or other history of coagulopathy.
* Known immunological impairment or dysfunction.
* Subjects who have received whole blood, plasma, and immunoglobulin therapy within one month.
* Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome.
* Known or suspected to suffer from: respiratory system disease，acute infection or chronic disease active period，severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease,children's mother has HIV infection and other serious and infectious diseases.
* In pregnancy or lactation or pregnant women.
* Subjects aged 18 years and above whose systolic blood pressure≥160mmHg and diastolic blood pressure≥100mmHg.
* Any contraindications that investigators consider related to vaccination.

Primary outcomes:
measure: Immunogenicity study endpoint
timeFrame: 30 day after each vaccination
measure: Safety study endpoint
timeFrame: 30 day after each vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Yizhou
country: China
facility: Yizhou Center for Disease Control and Prevention
state: Guangxi
Study officials:
affiliation: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
name: Du Lin, Master
role: STUDY_CHAIR
References:
Clinical trial NCT00542126: Luteal-Phase GnRH Agonist Administration in Frozen-Thawed IVF Embryo Transfer Cycles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Rate
Keywords: GnRH analog, IVF, infertility, frozen-thawed embryos
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2007-10-10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Supraphysiological hormonal stimulation enables collecting many oocytes in an In-Vitro Fertilization treatment, but may have a negative effect on uterine function and contribute the fact that the majority of preembryos placed in the uterus fail to implant.

Several medical agents were shown to be beneficial when given in the luteal phase of an IVF cycle, but the optimal regimen has not been yet determined. In 2006, a European group reported that addition of GnRH analog (Decapeptyl) as luteal support in IVF cycle significantly improved pregnancy and delivery rates. It is not known whether this positive effect influences the corpus luteum, embryo or the uterus. The researchers sought to evaluate the effect of GnRH administration as luteal support in frozen-thaws IVF cycle.


Eligibility criteria: Inclusion Criteria:

IVF patients transfer of a minimum of two medium-quality thawed embryos in IVF

Exclusion Criteria:

1. Two or more fresh IVF embryo transfer or three or more thawed embryos transfer with no pregnancy.
2. maximal endometrial thickness \< 6 mm or intracavitary fluid at the time of embryo transfer on previous cycles
3. Untreated hydrosalpinges
4. intracavitary mass
5. submucous myoma
6. known allergy to one of medical agents used in the study

Primary outcomes:
measure: pregnancy and delivery rates
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: IVF unit, Shaare-Zedek Medical Center
Study officials:
affiliation: Shaare-Zedek Medical Center, Jerusalem, Israel
name: Avi Tsafrir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.
Clinical trial NCT01388426: Moisture Chamber Glasses for Dry Eye in Asian Population
Official title: Moisture Chamber Glasses for Dry Eye in Asian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2011-07-06
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective of this study is to evaluate the tolerance and potential benefit of moisture chamber glasses for dry eye in an Asian population. In this clinic based prospective interventional study, we aim to recruit patients (until 10 patients complete the study) who have evaporative dry eye due to exposure to environmental stress (such as frequency of out door activities) and keen to try out moisture chamber glasses/ eyewear from the dry eye clinic in Singapore National Centre. After informed consent, these patients will be prescribed 7eye( Panoptx)™ moisture chamber glasses/eyewear for 3 months and will be monitored on a diary for the amount of time wearing eyewear for 2 weeks and the number of eye drops for each type of medication used. Other outcomes will be changes in symptoms of dry eye using visual analog scale, as well as objective signs of dry eye (eg. corneal fluorescence staining and tear break up time (TBUT). As moisture chamber spectacles are currently not available as a treatment option for dry eye in Singapore, the findings of this study will give an insight to the efficacy of this new treatment modality in our population.


Eligibility criteria: Inclusion Criteria:

1. Subjects with evaporative dry eye as assessed by the PI in the dry eye clinic and has occupational or lifestyle requirement to be exposed to a hyper-evaporative environment.

Exclusion Criteria:

1. Subjects who can't wear the eye wear as instructed in the study, or unable to complete the diary of eye wear use.
2. Subjects with eye lid or facial bone malformation
3. Subjects with a significant refractive error that warrants spectacles with a refractive power.

Primary outcomes:
measure: Percentage of time wearing moisture chamber glasses while outdoors during 2 weeks of the study.
timeFrame: 2 weeks during 3 months
Secondary outcomes:
measure: 1.Number of eyedrops per day for each type of medication used at the end of study vs at the commencement of study,symptoms of dry eye (using the VAS),corneal fluorescence staining and tear break up time(TBUT).
timeFrame: 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Center
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
affiliation: Singapore National Eye Centre
name: Samanthila Waduthantri
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore National Eye Centre
name: Louis Tong
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore National Eye Centre
name: Chien Hua Tan
role: STUDY_CHAIR
References:
Clinical trial NCT00569426: Evaluating the Use of Two Different Needles in Subjects With Diabetes
Official title: An Open-label, Randomised, Multi-centre Cross-over Trial in Diabetes Patients Evaluating Preference, Injection Pressure, Pain Perception and Handling When Injections Are Performed With Two Different Needles i.e. NovoFine® 32 Gauge Tip x 6mm and NovoFine® 30 Gauge x 8mm Using a FlexPen® Disposable Insulin Injection Pen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-12-07
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent obtained before any trial-related activities
* Diagnosed type 1 or type 2 diabetes
* Treated with insulin

Exclusion Criteria:

* Previous participation in this trial
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* Any disease or condition which the investigator feels would interfere with the trial

Primary outcomes:
measure: Overall needle preference
timeFrame: after 2-3 weeks of treatment
Secondary outcomes:
measure: Injection pressure
measure: Pain perception
measure: Handling and acceptance of needles
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Cardiff
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Church Village
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Haywards Heath
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Liverpool
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Livingstone
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Penarth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Plymouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: McKay M, Compion G, Lytzen L. Pain Perception, Patient Preference, Injection Pressure and Handling with NovoFine® 32G x 6mm Versus 30G x 8mm Needle. ADA 2006; : 1968-PO
Clinical trial NCT03060226: Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy
Official title: Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Merkel Carcinoma
Radiotherapy Side Effect
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Search for blood predictive marker (s) for cutaneous radiosensitivity


Eligibility criteria: Inclusion Criteria:

* Patient treated with surgery and radiotherapy (RT) for histologically proven Merkel carcinoma
* Previous radiotherapy treatment completed for at least 6 months
* Absence of prior treatment by chemotherapy or hormonotherapy
* Patient over 18 years of age
* Patient affiliated to a social security system
* Informed consent signed

Exclusion Criteria:

* Presence of another evolutionary cancer
* Re-irradiation in the same area
* Absence of available dosimetry data
* Patient under guardianship or curatorship or safeguard of justice

Primary outcomes:
measure: Identification and dosage of blood predictive marker(s)
timeFrame: 1 blood sample at inclusion
measure: Identification and dosage of blood predictive marker(s)
timeFrame: 1 blood sample at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: France
country: France
facility: Centre François Baclesse
Study officials:
References:
Clinical trial NCT04373226: Arithmetic Abilities in Children With 22q11.2DS
Official title: Study of Arithmetic Abilities of Children With 22q11.2 Deletion Syndrome Aged From 4 to 11 Years Old
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 22q11.2 Deletion Syndrome
Keywords: 22q11.2 deletion syndrome
arithmetic
magnitude representation
children
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 41
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric study with two parallel groups
Primary purpose: BASIC_SCIENCE

Brief summary: The study ARITH22 will investigate the role of visuo-spatial attention on arithmetic abilities of children with 22q11.2 deletion syndrome.

Detailed description: Children with 22q11.2 deletion syndrome often have arithmetic learning disability because of magnitude representation impairment. Previous works suggested that magnitude representation impairment could be a result of endogenous visuo-spatial attention dysfunction in 22q11.2DS. Nevertheless this relationship is still poor explored. The influence of visuo-spatial abilities on arithmetic achievement could also be modulated by developmental age. The study ARITH22 will test these hypotheses thanks to magnitude comparisons tasks, in children with 22q11.2 deletion syndrome and matched children without developmental disease.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of 22q11.2 deletion syndrome or no developmental disease
* Aged from 4 to 11 years old
* French language

Exclusion Criteria:

* Diagnosis of intellectual deficiency according to DSM 5 criteria
* Drug prescribed for somatic condition that could influence cerebral functioning

Primary outcomes:
measure: Percentage of impaired scaled score
timeFrame: single day
Secondary outcomes:
measure: Percentage of correct responses
timeFrame: single day
measure: Mean reaction time
timeFrame: single day
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Vinatier
state: Rhone Alpes
Study officials:
affiliation: Centre Hospitalier le Vinatier
name: Caroline DEMILY, MD PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03682926: Electrostimulation PROTOCOL Incontinence
Official title: EFFECT OF A PROTOCOL Electrostimulation for Urinary Incontinence and Its Influence on WOMEN 'S QUALITY OF LIFE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Stress Incontinence
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To verify the effect of an adapted electrostimulation (EE) protocol for stress and mixed urinary incontinence (SUI / M) and its impact on quality of life (QoL)

Detailed description: Controlled and randomized clinical trial performed at the Physiotherapy Outpatient Clinic at the Magalhães Neto Pavilion of ComHUPES / UFBA. Women aged between 30 and 65 years and diagnosis of SUI / IUM. The patients were allocated to two groups (GA) submitted to selective electrostimulation for tonic fiber, phasic fibers IIa / IIb and different times of electrical stimulation; (GB) used 50hz for all fibers by 20mm, both answered the questionnaire King's Health Questionnaire (KHQ).

Eligibility criteria: Inclusion Criteria:

* women between the ages of 30 and 65
* With diagnosis of stress urinary incontinence and / or mixed
* Perineal muscle weakness
* Accepted to sign the TCLE

Exclusion Criteria:

* Women with neurological changes
* Pregnant women
* IUD use
* Pacemaker
* Genitourinary tract infection
* Cancer
* Refuse to sign the TCLE

Primary outcomes:
measure: contractile function of the perineal musculature
timeFrame: 3 months
Secondary outcomes:
measure: King's Health Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06932926: Remineralization Effect Of Egg Shell Versus Fluoride Varnish On Early Carious White Spot Lesions In Primary Teeth
Official title: Remineralization Potential Of Egg Shell Hydrogel Versus Fluoride Varnish On Early Carious White Spot Lesions In Anterior Primary Teeth: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: White Spot Lesion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to to assess the remineralization potential of Egg shell hydrogel versus fluoride varnish in early carious white spot lesions in anterior primary teeth.

The main question it aims to answer is:What is the remineralization potential of egg shell hydrogel on early carious white spot lesions compared to fluoride varnish in anterior primary teeth? Researcher will compare egg shell hydrogel with fluoride varnish to see if it is able to promote lesion remineralization.

interventions that will be given to participasnts: egg shell hydrogel \& five percent sodium fluoride varnish


Eligibility criteria: Inclusion Criteria:

1. Children aged 3 to 5 years, in good general health, and medically free.
2. Prescence of at least one WSL on anterior primary teeth with an ICDAS II score of one or two.
3. Cooperative patients who will comply with follow-ups.
4. Parents who accept to sign informed consent.

Exclusion Criteria:

1. Uncooperative children.
2. Children with a physical disability or medical disability.
3. Children with teeth that shows enamel hypoplasia.
4. Children that have received a fluoride supplement or professional topical fluoride application at least 3 months before the study.
5. Parents refuse to give written formed consent.

Primary outcomes:
measure: Remineralization potential.
timeFrame: at 6th , 18 and 30th week
Secondary outcomes:
measure: Activity of the lesion
timeFrame: will be assessed using Nyvad's criteria at 6th , 18 and 30th week
measure: Oral hygiene
timeFrame: at 6th , 18 and 30th week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04849026: Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18
Official title: A Randomized, Open Label, Multiple-dose, 2-way Crossover, Phase I Study to Compare the Safety and Pharmacokinetics Profile of WID-CLZ18 and Clozaril 100 mg Tablet (Clozapine) After Oral Administration in Schizophrenia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Whanin Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical study is a randomized, open label, multiple-dose, 2-way crossover, phase I (Bioequivalence) study to compare the safety and pharmacokinetics profile of WID-CLZ18 and Clozaril 100 mg tablet (Clozapine) after oral administration in schizophrenia patients.


Eligibility criteria: Main Inclusion Criteria:

1. Males and females adults aged 20 to 65 years
2. Diagnosed as schizophrenia prior to the screening visit
3. On treatment with a stable dose of clozapine 200 mg/day for at least 12 weeks before the screening visit and taken at 100 mg twice daily during the study period

Main Exclusion Criteria:

1. Subjects who have a medical history specified in protocol
2. Subjects with confirmed abnormal laboratory values specified in protocol
3. Subjects who have a medication history or safety risks specified in protocol
4. Subjects who can not comply with requirements of pharmacokinetic sampling as per protocol
5. Subjects who are expected to have the prohibited concomitant medication therapy during the study period
6. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy
7. Subjects who are not suitable for the clinical trial

Primary outcomes:
measure: Cmax
timeFrame: Up to 12 hours
measure: AUC0-12
timeFrame: Up to 12 hours
Secondary outcomes:
measure: Tmax
timeFrame: Up to 12 hours
measure: T1/2
timeFrame: Up to 12 hours
measure: R
timeFrame: Up to 12 hours
measure: Cmin
timeFrame: Up to 12 hours
measure: Fluctuation
timeFrame: Up to 12 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Whan In Pharm.
Study officials:
affiliation: Department of Psychiatry, Naju National Hospital
name: Bo-Hyun Yoon
role: PRINCIPAL_INVESTIGATOR
References: