louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00382772: A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).
Official title: Study to Evaluate Clinical Consistency of the Liquid Formulation of GSK Biologicals' HRV Vaccine and to Evaluate Liquid Formulation Compared to Lyophilised Formulation of the HRV Vaccine Administered as a Two-dose Primary Vaccination.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Rotavirus
Keywords: HRV vaccine
Diarrhoea
Rotavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-02
Enrollment: 1200
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered concomitantly with a combination childhood vaccine.


Eligibility criteria: Inclusion Criteria:

* Healthy infants birth weigh \>2000 g, 11 -17 weeks old at Dose 1 with written informed consent.

Exclusion Criteria:

* Allergic reaction to vaccine components; clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; immunocompromised.

Primary outcomes:
measure: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.
Secondary outcomes:
measure: Assess lot-to-lot consistency in terms of reactogenicity and assess safety of HRV vaccines.
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Jarvenpaa
country: Finland
facility: GSK Investigational Site
city: Kotka
country: Finland
facility: GSK Investigational Site
city: Lahti
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Pori
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Vantaa
country: Finland
facility: GSK Investigational Site
city: Vantaa
country: Finland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Vesikari T, Karvonen A, Bouckenooghe A, Suryakiran PV, Smolenov I, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 oral suspension (liquid formulation) in Finnish infants. Vaccine. 2011 Mar 3;29(11):2079-84. doi: 10.1016/j.vaccine.2011.01.004. Epub 2011 Jan 14.
Clinical trial NCT05377372: Early Life Exposures Among Children With Sickle Cell Disease
Official title: Early Life Exposures Among Children With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Adverse Childhood Experiences
Breastfeeding
Keywords: Sickle cell disease
Adverse Childhood Experiences
Breastfeeding
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: PREVENTION

Brief summary: This study is being conducted to determine the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health and nutrition/breastfeeding, among children with sickle cell disease, and behavioral interventions aimed to reshape psychological resilience and lifestyle factors towards positive health outcomes.

Detailed description: During year 3 of the award period, 20 mother-infant dyads will be randomly assigned to either a community-based breastfeeding support group or observation. Acceptability to enrollment, intervention adherence for at least 6 months and preliminary effectiveness will be captured. Biomarkers of inflammation, development of asthma and incidences of pain and/or acute chest syndrome will be compared among the intervention and control groups.

Eligibility criteria: Inclusion Criteria:

* mother of infant with sickle cell disease
* resides within the city of Birmingham, Alabama or in close proximity

Exclusion Criteria:

* prescribed teratogenic medications
* no/limited internet access

Primary outcomes:
measure: Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention
timeFrame: 6 months
measure: Preliminary Effectiveness
timeFrame: 2 years
Secondary outcomes:
measure: Asthma
timeFrame: 4 year follow up period
measure: Acute chest syndrome
timeFrame: 4 year follow up period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Brandi M Pernell, DNP, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02460172: Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
Official title: A Prospective, Randomized Controlled Post-market Study to Compare the Use of the Zip® Surgical Skin Closure Device Versus Conventional Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Knee Replacement
Wound Healing
Keywords: bi lateral
knee surgery
arthroplasty
orthopedics
Lead sponsor: ZipLine Medical Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.

Detailed description: Prospective, randomized, within patient control study comparing the use of Zip Surgical Skin Closure device versus conventional staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi lateral total knee replacement. A total of up to 25 patients will be enrolled and followed for up to 8 weeks post surgery to evaluate wound healing and overall satisfaction of closure method.

Eligibility criteria: Inclusion Criteria:

1. Patients 18 years of age and older
2. Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty
3. Patients willing to be evaluated at discharge, 2 weeks, and at the 6 to 8 week post op

Exclusion Criteria:

1. Known bleeding disorder not caused by medication
2. Known personal or family history of keloid formation or scar hypertrophy
3. Known allergy or hypersensitivity to non-latex skin adhesives
4. Atrophic skin deemed clinically prone to blistering
5. Any skin disorder affecting wound healing
6. Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study

Primary outcomes:
measure: Incision Appearance / Scar Cosmesis
timeFrame: 6-8 weeks post surgery
Secondary outcomes:
measure: Surgeon Closure Method Satisfaction
timeFrame: 6-8 weeks post op
measure: Patient Pain - Incisional and General
timeFrame: Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit)
measure: Surgeon and Patient Scar Satisfaction
timeFrame: 6 to 8 wk follow up visit
measure: Range of Motion
timeFrame: 2 weeks and 6-8 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Shelbourne Knee Center
state: Indiana
Study officials:
affiliation: Study Center
name: Rodney Benner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05698472: A Study on the Status Quo of Physical Exercise for the Elderly
Official title: A Study on the Status Quo of Physical Exercise for the Elderly in Beijing Community
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Physical Exercise
Elderly
Community
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The elderly who has lived in Beijing for a long period and is older than 65 years old.

Brief summary: Through interview, taking the elderly community in Beijing as an example, this study will try to further understand the current physical exercise situation of the elderly in the community, and analyze the factors influencing their participation degree. By this way, we will try to provide constructive suggestions for the development and design of universal community physical exercise programs for the elderly.


Eligibility criteria: Inclusion Criteria:

1. Regardless of gender, age ≥ 65 years old
2. Lived in Beijing for a long time
3. Normal listening, speaking, and comprehension skills

Exclusion Criteria:

1. Accompanied by significant cognitive dysfunction
2. Diseases that seriously affect their participation in sports, such as fractures, tumors, neurological diseases, etc.

Primary outcomes:
measure: questionnaire
timeFrame: 1 day (once)
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03598972: the Effect of Prenatal Vitamins on the Tooth Structure
Official title: the Effect of Prenatal Vitamins on the Children Teeth: Elementary Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy children within the normal period of teeth shedding

Brief summary: the effect of mother prenatal care on the teeth of the newborn children, if it affect the tooth structure or not

Detailed description: teeth lost due to normal shedding will be collected,it will be classified into mother that take pregnancy vitamins and mother that doesn't take pregnancy vitamins, the female will be from the same population and from the same city to make sure that the environmental condition are almost the same .teeth will be subjected to elementary analysis to determine the different ratio of different component and if there is any change between the two group

Eligibility criteria: Inclusion Criteria teeth lost due to normal shedding sound teeth with non hereditary conditions normal children mother that don not suffer from chronic illness ex: diabetes

Exclusion Criteria:

* teeth extracted due to caries or trauma teeth with hereditary anomalies ex: hypoplasia

Primary outcomes:
measure: the different teeth minerals and component
timeFrame: 3months
Secondary outcomes:
measure: caries index of chlidren
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01612572: A Registry Study on Xiyanping(a Chinese Medicine Injection) Used in Fifty Hospitals
Official title: A Registry Study on Safety Surveillance of Xiyanping (a Chinese Medicine Injection) Used in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Viral Pneumonia
Bronchitis
Infantile Diarrhea
Bacillary Dysentery
Virus Hepatitis
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An anticipated sample size was caculated in this study, about 20000. Patients using Xiyanping injection from 2012 to 2014 in more than 50 hospitals

Brief summary: This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Xiyanping is kind of Chinese Medicine injection used for treating viral pneumonia 、bronchitis、amygdalitis、infantile diarrhea、bacillary dysentery 、virus hepatitis、and Children acute hot diseases in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

Detailed description: It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Xiyanping injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use Xiyanping injection in selected hospitals.

Eligibility criteria: Inclusion Criteria:

* Xiyanping injection from 2012 to 2014

Primary outcomes:
measure: Number of participants with adverse events; incidence of Xiyanping'ADRs and identify factors that contributed to the occurrence of the adverse reaction
timeFrame: The registry procedure will last 3 years only for patients using Xiyanping.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yan M Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06351072: Correlation Between qNOX and Analgesia Nociception Index (ANI) Values During General Anesthesia
Official title: Correlation Between qNOX Values of the CONOX Monitor and Analgesia Nociception Index (ANI) Values During General Anesthesia Conducted With Propofol and Remifentanil TCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing brast cancer surgery with general anesthesia with Propofol and remifentanil TCI will be recruited

Brief summary: qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia.

No trials have compared them, so with this trial authors want to explore the correlations between them.

Detailed description: qNOX and ANI are two indexes evaluting the anaglesia conduction during general anesthesia.

Even if the aim is the same (to measure the nociception level) these indexes utilize different algorithm: the qNOX is derived by the electroencephalogrm (EEG), the ANI is derived by heart rate variation.

No trials have compared them, so with this trial authors want to explore the correlations between them, and if altered values of one of them is stronger related to postoperative pain and delirium.

Eligibility criteria: Inclusion Criteria:

* Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and remifentanil (Eleveld model)

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Obesity
* Regional anesthesia performed

Primary outcomes:
measure: Correlation between qNOX and ANI values
timeFrame: qNOX, ANI, pupoillometry values, propofol and remifentanil concentration during induction, intubation, after post-tetanic count at the trend-of-four and maintenance phase of general anesthesia detected with target controlled inusion will be paired.
Secondary outcomes:
measure: Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain
timeFrame: qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative pain, evalued with NRS score after 24 hours
measure: Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium
timeFrame: qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative delirium, evaluated with CAM and 4AT score after 24 hours
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Treviso Regional Hospital
state: TV
Study officials:
References:
Clinical trial NCT00140972: A Study to Assess Etoricoxib Versus Diclofenac in Chinese Patients With Osteoarthritis of the Knee or Hip (0663-080)(COMPLETED)
Official title: A Multicenter, Randomized, Parallel-group, 4-Week, Double-Blind and Active Comparator-Controlled Study to Assess Efficacy, Safety, and Tolerability of Etoricoxib 60 mg Once Daily Versus Diclofenac Sodium 75 mg Twice Daily in the Treatment of Chinese Patients With Osteoarthritis of the Knee or Hip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Arcoxia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Study to Assess Etoricoxib versus Diclofenac in Chinese Patients with Osteoarthritis of the Knee or Hip


Eligibility criteria: Inclusion Criteria:

* Chinese males or females at least 40 years of age with osteoarthritis of the knee or hip

Primary outcomes:
measure: WOMAC pain subscale
Secondary outcomes:
measure: WOMAC Physical function subscale; WOMAC Stiffness subscale; Patient Global Assessment of Response to Therapy; Investigator Global Assessment of Disease Status
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Zhang F, Li Z, Yang N, Wu D, Sun L, Wu H. The clinical study of etoricoxib in the treatment of Chinese patients with osteoarthritis: a randomized double-blind trial. Chinese J of Rheum. 2013;17(5):307-312.
Clinical trial NCT02269072: Testosterone Regulation of the Natriuretic Peptide System
Official title: Testosterone Regulation of the Natriuretic Peptide System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Keywords: Natriuretic Peptide
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The proposed study is a physiologic investigation of the effects of testosterone on the natriuretic peptide system. The hypotheses of the study are that testosterone administration will decrease natriuretic peptide levels and salt excretion. The entire protocol is 8 weeks in duration.


Eligibility criteria: Inclusion Criteria:

* Men: aged 18 to 40 years, normal testosterone and free testosterone levels, no history of hypertension, and BMI between 18.5 and 25.
* Women: aged 18 to 40 years old, regular menstrual periods, negative pregnancy test, no oral contraceptives for ≥ 3 mos, no history of hypertension, BMI between 18.5 and 25.

Exclusion Criteria:

* Antihypertensives, diuretics or insulin, diabetes mellitus, prior cardiovascular, abnormal liver or renal disease, history of cancer, atrial fibrillation, or abnormal sodium or potassium level.

Primary outcomes:
measure: Atrial natriuretic peptide levels
timeFrame: 8 weeks
Secondary outcomes:
measure: Urinary salt excretion
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Karen K Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05851872: Fasting Versus Non-fasting on Outcomes and Satisfaction Prior to Cardiac Catheterization
Official title: A Randomized Trial of Fasting Versus Non-fasting on Outcomes and Satisfaction Prior to Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Moderate sedation is used in the catheterization laboratory relieve the anxiety and discomfort associated with access and other aspects of the procedure. Whether being in a fasting state (nothing per os, NPO) at the time of the procedure is beneficial or harmful is not well known, but patients are typically required to be fasting at the time of elective procedures, guidance derived from procedures that require general anesthesia. Whereas the typical thinking was that fasting prior to procedures would minimize the risk of aspiration in the event of intubation, or nausea and other symptoms generally, several studies have shown that prolonged fasting prior to procedures is associated with increased nausea, vomiting, aspiration and procedure recovery time.

We aim to evaluate patient satisfaction, nausea and immediate outcomes of patients who are not kept NPO prior to cardiac catheterization.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Requiring a cardiac catheterization as per standard of care
* Elective procedure with planned moderate sedation

Exclusion Criteria:

* BMI \>45
* All emergent procedures
* All mechanical circulatory support-assisted procedures
* Other high risk procedures (as identified by the operator)
* Pregnant women
* Hemodynamically unstable patients
* Active GI illness, including nausea at the time of screening
* Taking chronic pain medications at home or on current brief course of narcotics
* Dementia
* Encephalopathy
* Patients scheduled for deep sedation
* Severe GERD (if the patient requires more than one medication for adequate control of GERD symptoms or has required medical intervention within the past year)

Primary outcomes:
measure: Pre-procedure wellness score (hunger, tiredness, anxiety, nausea)
timeFrame: Baseline (Prior to procedure)
measure: Intra- and post-procedural vomiting, aspiration, and intubation checklist
timeFrame: Within 24 hours after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Zachary Gertz, MD
role: PRINCIPAL_INVESTIGATOR
References: