louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05839782: Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair
Official title: Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Mitral Valve Disease
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a failure of mitral valve repair. The patients are divided in 2 groups depending on type of reintervention: a new mitral valve repair (PLM) or mitral valve replacement (SVM)

Brief summary: The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the implantation of a biological prosthesis or a mechanical prosthesis.

However, PLM has a rate of failure, between 1-4% per year in degenerative mitral pathologies. As a result, patients with PLM failure and severe residual regurgitation are increasingly presenting in recent years.

Generally these patients are re-operated to replace the mitral valve. Our aim is to investigate the differences in re-operation involving mitral valve replacement or re-repair in patients who underwent mitral valve re-operation (re-repair or replacement) in our center between 2003 and 2017.


Eligibility criteria: Inclusion Criteria:

* adult patients
* failure of previous mitral valve repair which needed a new surgical treatment
* group Re-PLM: patients reoperated with a new mitral valve repair
* group Re-SVM: patients reoperated with a mitral valve replacement

Exclusion Criteria:

* urgent/emergent procedures

Primary outcomes:
measure: Survival after reintervention
timeFrame: through study completion, a minimum of 2 years
Secondary outcomes:
measure: Risk factors for reintervention
timeFrame: through study completion, a minimum of 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele - Cardiac Surgery Department
Study officials:
References:
Clinical trial NCT06554782: Children's Compliance With Toothbrushing Using Manual U-shaped Toothbrush Versus Regular Toothbrush
Official title: Children's Compliance With Toothbrushing Using Manual U-shaped Toothbrush Versus Regular Manual Toothbrush
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Manual Toothbrush
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 47
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess the child's compliance towards manual U-shaped toothbrush versus regular manual toothbrush.

Detailed description: Research has shown that an undesirably high proportion of communities find thorough toothbrushing with a standard manual toothbrush challenging to achieve a plaque-free state, as evidenced by high worldwide gingivitis and periodontitis. This is consistent with investigations that reveal insufficient frequency of brushing, poor brushing technique, and inadequate brushing session duration when compared with standard-of-care professional recommendations.

The U-shaped brush is an intervention chosen for the present study because it can attract children's attention and make brushing fun and routine. With bristles angled at 45° and available in various sizes according to age, the U-shaped brush is useful for removing plaque. It can be used starting at age three or older. It is dependable for children because its two-sided design can clean the upper and lower arches in one motion. Since design affects plaque removal to varying degrees, various authors have examined the effects of different toothbrush designs on plaque removal.

Eligibility criteria: Inclusion Criteria:

1. children aged 5 to 10 years, in good general health, and medically free.
2. Cooperative patients who will comply with follow-ups.
3. Parents who accept to sign informed consent.

Exclusion Criteria:

1. Children with fixed or removable orthodontic appliances.
2. Children with a physical disability, and medical disability.
3. Children who will be unable to attend follow-up visits.
4. Parents refuse to give written formed consent.

Primary outcomes:
measure: compliance of patient
timeFrame: 1 week
Secondary outcomes:
measure: full mouth plaque score
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Randa Youssef AbdelGawad, professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Rana Tarek Bartaw, assistant professor
role: STUDY_DIRECTOR
References:
citation: Ashkenazi M, Bidoosi M, Levin L. Factors associated with reduced compliance of children to dental preventive measures. Odontology. 2012 Jul;100(2):241-8. doi: 10.1007/s10266-011-0034-1. Epub 2011 Jun 23.
citation: Davidovich E, Ccahuana-Vasquez RA, Timm H, Grender J, Cunningham P, Zini A. Randomised clinical study of plaque removal efficacy of a power toothbrush in a paediatric population. Int J Paediatr Dent. 2017 Nov;27(6):558-567. doi: 10.1111/ipd.12298. Epub 2017 May 11.
Clinical trial NCT02277782: Intrathecal Hydromorphone for Labor Analgesia
Official title: Intrathecal Hydromorphone for Labor Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy
Keywords: Labor
Analgesia
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the effect of intrathecal hydromorphone on the duration of labor analgesia and the incidence of epidural-associated temperature increase in laboring parturients. We hypothesize that intrathecal administration of longer-acting hydromorphone will:

1. Prolong the duration and improve the quality of analgesia in labor, and
2. Decrease the incidence of epidural-associated temperature increase in labor.


Eligibility criteria: Inclusion Criteria:

* Patients are eligible for enrollment if they are healthy, pregnant females between the ages of 18 and 45 years, primiparous, and at term gestation (≥ 37 weeks).

Exclusion Criteria:

* Patients with a Category II or III fetal heart rate tracing, a fetus with intrauterine growth restriction, prolonged rupture of membranes, recent diagnosis of infection of any cause, or in whom dural puncture is contraindicated will be excluded from the study.

Primary outcomes:
measure: Effect on maternal temperature during labor
timeFrame: 2 years
Secondary outcomes:
measure: Effect on efficacy of labor analgesia
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03503682: Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases
Official title: SHort Course Accelerated RadiatiON Therapy (SHARON) in Complicated Bone Metastases Palliation: an Interventional, Randomised, Multicentric Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Metastases
Radiotherapy
Palliative Care
Keywords: Short Course Radiotherapy
Complicated Bone Metastases
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases

Detailed description: Standard treatment for complicated bone metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (4000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme.

Eligibility criteria: Inclusion Criteria:

* complicated bone metastases from any solid tumor
* age \>18 years
* ECOG performance status 0-3
* symptomatic lesion (NRS \>1)
* no changes in analgesic treatment at least in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previously irradiation of the same region

Primary outcomes:
measure: Efficacy of palliation using the short course scheme compared with the standard scheme
timeFrame: 3 months
Secondary outcomes:
measure: Acute toxicity in the two treatment groups
timeFrame: 3 months
measure: Late toxicity in the two treatment groups
timeFrame: 12 months
measure: Quality of Life (QoL) assessment in the two groups
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
state: BO
Study officials:
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02416882: Exercise Genes: Genomic Association With Exercise Reinforcement
Official title: Exercise Genes: Genomic Association With Exercise Reinforcement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Physical Activity
Keywords: active
not active
normal body weight
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2015-04-15
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study tests whether different physical activity patterns are linked an individual's genes.

Detailed description: The investigators propose that an individual's genetics are one factor that may be associated with the motivating aspect or attractiveness of exercise and therefore the choice to exercise rather than be sedentary. They propose to study the association of the genomic signatures with the reinforcing (motivating) value of different types of exercise. This has never been investigated and may uncover underlying mechanisms that would help to understand individual differences in exercise motivation. The ultimate impact of this work is a greater number of Americans being physically active, meeting the United States Department of Agriculture (USDA) dietary guidelines for physical activity, and maintaining a healthy body weight. This study will be funded and undertaken at the Grand Forks Human Nutrition Research Center (GFHNRC). The purpose will be to assess genetic underpinnings of the motivating value of resistance and aerobic exercise, and to determine whether the motivating value of aerobic and resistance exercise are associated with usual participation in these modes of exercise.

Eligibility criteria: Inclusion Criteria:

* BMI within 18.5-35.0 kg/m2
* Healthy enough to exercise
* Active or inactive (not exercising at this time)

Exclusion Criteria:

* Taking any drugs that affect energy expenditure (e.g., thyroid, glucose-lowering drugs)
* Have gained or lost more than 5% of body weight over the past 6 months
* Use tobacco
* Pregnant or lactating or plan to become pregnant in the next 6 months
* Have any health conditions that prevent the individual from safely exercising (e.g., cardiovascular, liver, endocrine, or pulmonary diseases)

Primary outcomes:
measure: Relative reinforcing value (RRV) of physical activity
timeFrame: Week 0 (Cross-sectional)
measure: Preference for intense physical activity and tolerance for exercise discomfort
timeFrame: Week 0 (Cross-sectional)
measure: Genotypes of 23 small nucleotide polymorphisms (SNPs) previously identified to influence central dopamine release or uptake, reward, or physical activity
timeFrame: Week 0 (Cross-sectional)
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: James N Roemmich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00590382: Emergency/Compassionate Use - Muscular VSD Occluder
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Muscular
Ventricular
Septal
Defects
VSD
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-01-10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access to the AMPLATZER Muscular VSD Occluder


Eligibility criteria: Inclusion Criteria:

* Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER Muscular VSD clinical trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00956982: PEG-IFN Plus Ribavirin Combination Therapy for Older Patients
Official title: Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C Virus
Keywords: Hepatitis C Virus Pegylated Interferon Ribavirin Older
Lead sponsor: Kyushu University
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 1251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(\< 65 years old).


Eligibility criteria: Inclusion Criteria:

* A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008.
* All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled.

Exclusion Criteria:

* Clinical or biochemical evidence of hepatic decompensation.
* Advanced cirrhosis identified by large esophageal varices (F2 or F3).
* History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma.
* Hemoglobin level \< 11.5g/L, white blood cell count \< 3×10９/Ｌ，and platelet count \< 50×10９/Ｌ.
* Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive).
* Excessive active alcohol consumption \> 60 g/day or drug abuse.
* Severe psychiatric disease.
* Antiviral or corticosteroid therapy within 12 months prior to the enrollment.

Primary outcomes:
measure: antiviral effect by PEG-IFN alpha-2b plus RBV treatment
timeFrame: 24-weeks follow-up after the end of treatment
Secondary outcomes:
measure: the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment
timeFrame: during PEG-IFN alpha-2b plus RBV treatment (48 weeks)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Department of General Medicine, Kyushu University Hospital
Study officials:
affiliation: Department of General Medicine, Kyushu University Hospital
name: Jun Hayashi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00722020: HFCWO in Hospitalized Asthmatic Children
Official title: High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Asthma
Asthma
Status Asthmaticus
Keywords: Asthma
Bronchial Disease
Status Asthmaticus
High Frequency Chest Wall Oscillation
the Vest
HFCWO
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma.

Detailed description: A historically controlled pilot study was conducted in pediatric patients 18 months to 18 years of age hospitalized with a diagnosis of asthma or reactive airway disease and admitted to the pediatric intensive care unit. Upon receiving informed consent, patients were treated with HFCWO therapy via the VEST. The primary endpoint was time to readiness for discharge, lack of need for continued supportive care (e.g., intravenous fluid or oxygen), and bronchodilator treatments spaced at least four hours apart.

Eligibility criteria: Inclusion Criteria:

* Any pediatric patient between the ages of 18 months and 18 years admitted to Winthrop University Hospital's pediatric floor or intensive care unit with a diagnosis of asthma or reactive airway disease

Exclusion Criteria:

* Patients with chronic, comorbid respiratory conditions (e.g., cerebral palsy, cystic fibrosis)
* Those who regularly use HFCWO
* Any patient exhibiting an absolute contraindication to HFCWO therapy
* Absolute contraindications to using HFCWO include head and neck injury prior to stabilization, and active hemorrhage with hemodynamic instability

Primary outcomes:
measure: The Primary Endpoint Will be Time to Readiness for Discharge.
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Endpoint Total Hospital Length of Stay
timeFrame: 30 Days
Other outcomes:
Locations:
city: Long Island City
country: United States
facility: Winthrop University Hospital, Winthrop Pediatric Associates
state: New York
city: Long Island City
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Winthrop University
name: Jon Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02991820: VL vs DL in Inexperienced Users: a Pediatric Manikin Study
Official title: Comparison of Miller and Macintosh Laryngoscopes, CMAC and Glidescope Videolaryngoscopes in Inexperienced Users: a Pediatric Manikin Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Videolaryngoscopes (VL)
Direct Laryngoscopy (DL)
Inexperienced Users
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance of users. This will involve the use of an intubating pediatric manikin to assess various aspects of endotracheal intubation by experienced and inexperienced users.

Detailed description: The commonly used method for endotracheal intubation in children is direct laryngoscopy using a Miller or Macintosh blade. Videolaryngoscopy is a widely accepted pediatric airway management. Videolaryngoscopes (VL) provide an indirect view of glottis without the need to align the oral, pharyngeal, and glottis structures. Some types of VLs provide also direct view of glottis with indirect view. Videolaryngoscopes can be used as a teaching tool for learners as they can visualize all the anatomical structures of larynx at the same time with the performer. VLs may facilitate the learning of endotracheal intubation in inexperienced users in the pediatric population. There are limited data on the use of videolaryngoscopes by anesthesia providers and medical personnel who are inexperienced in the use of videolaryngoscopes.

Eligibility criteria: Inclusion Criteria:

* Faculty pediatric anesthesiologists
* CRNAs
* Trainees (SRNAs, residents, fellows, and medical students)
* Nurses from NCH

Exclusion Criteria:

* If subjects are unwilling to participate.

Primary outcomes:
measure: Time to Endotracheal Intubation
timeFrame: the same day (within seconds to minutes)
Secondary outcomes:
measure: Successful Intubation Within 120 Seconds
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01885520: Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg
Official title: A Randomized,Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg After Oral Administration in Healthy Adult Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Low Back Pain
Keywords: low back pain
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone HCl SR tablet

Detailed description: eperisone hydrochloride(muscle relaxant)

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects age between 20 and 55 signed informed consent

Exclusion Criteria:

* Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

Primary outcomes:
measure: AUC
timeFrame: 0-24h
measure: Cmax
timeFrame: 0-24h
Secondary outcomes:
measure: T1/2
timeFrame: 0-24h
measure: Tmax
timeFrame: 0-24h
Other outcomes:
Locations:
city: Jung-gu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Daegu
Study officials:
affiliation: Kyungpook National University Hospital
name: Yoon Yo Ran, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: