louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01438684: The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study
Official title: Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Chronic Vegetative State
Keywords: chronic vegetative state
functional MRI
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 10
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: The aim is to evaluate the impact of RPh201 on brain activity in chronic vegetative state patients. The assessment will be done using clinical measurements and functional MRI studies.


Eligibility criteria: Inclusion Criteria:

* chronic vegetative state patients

Exclusion Criteria:

* allergic reaction to treatment
* patients that can not undergo MRI
* Pregnancy

Primary outcomes:
measure: consciousness level measured clinically
timeFrame: 6 months
Secondary outcomes:
measure: Functional magnetic resonance imaging of cortical activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Netta Levin
Study officials:
References:
Clinical trial NCT06201884: Efficacy of Adapted Physical Activity on a Walking Platform in Elderly Patients HOspitalized for Cancer Surgery
Official title: Efficacy of Adapted Physical Activity on a Walking Platform in Elderly Patients HOspitalized for Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Oncology
Elderly Patients
Surgery
Keywords: Adapted physical activity
walking platform
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to evaluate the efficacy of daily use of a walking platform to improve recovery of preoperative walking speed at hospital discharge following oncological surgery in patients aged 65 or older.


Eligibility criteria: Inclusion Criteria:

* Men or women aged 65 or over
* Candidate for scheduled major oncological surgery and/or surgery with high morbidity
* Patient able to walk for 10 minutes on the walking platform at the time of the test
* Patient affiliated to a social security system
* Signature of informed consent prior to any specific study-related procedure

Exclusion Criteria:

* Patient with severe undernutrition (BMI\<18, and/or weight loss \>15% in 6 months or \>10% in 1 month)
* Emergency surgery
* Physical contraindications preventing use of the platform
* Simultaneous participation in another clinical study that could compromise the conduct of this study
* Patients deprived of their liberty, under guardianship or subject to a legal protection measure, or unable to express their consent.
* Patient unable to undergo trial follow-up for geographical, social or psychopathological reasons.

Primary outcomes:
measure: To evaluate the efficacy of daily use of a walking platform to improve recovery of preoperative walking speed at hospital discharge following oncological surgery in patients aged 65 or older.
timeFrame: at hospital discharge (approximately 15 to 30 days after surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Francois Baclesse
city: Caen
country: France
facility: CHU CAEN
Study officials:
References:
Clinical trial NCT06242184: Post-operative Sensitivity in Resin Composites
Official title: Post-operative Sensitivity in Composites Using Bacillus Subtilis Procured Novel Nano-fortified Adhesive: a Triple-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries,Dental
Sensitivity, Tooth
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2024-02-05
Enrollment: 60
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: This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. In group A, adhesive with nanoparticles was used for composite restoration while in group B, adhesive without nanoparticles was utilized. Post-operative sensitivity was recorded using VAS score.

Detailed description: Triple-blind, randomized trial, parallel group with an allocation ratio 1:1. A total of 60 participants were recruited from the outpatient department and were randomly distributed into two groups (n=30). After informed consent, restorative treatment was accomplished using an etch and rinse adhesive strategy. In group A , titanium dioxide nano-fortified adhesive was used while in group B, adhesive without nanoparticles was utilized for composite restoration. Post-operative sensitivity was evaluated at follow-up period: one day, one week, two weeks and one month. Visual Analogue scale score was used to record the sensitivity status at follow-up intervals.

Eligibility criteria: Inclusion Criteria:

* participants with goof general health status
* Class I and II primary Carious lesion with a minimum cavity depth of 3 to 5 mm.
* Vital and Periodontally sound teeth

Exclusion Criteria:

* Patient with Temporomandibular dysfunction
* History of spontaneous pain
* Endodontically treated teeth
* Patient on analgesics within the past two weeks

Primary outcomes:
measure: Post-operative sensitivity
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University
Study officials:
affiliation: Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
name: Nehal Amir, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aboelenein AZ, Riad MI, Haridy MF. Effect of a Self-Etch Adhesive Containing Nanobioglass on Postoperative Sensitivity of Posterior Composite Restorations - A Randomized Trial. Open Access Maced J Med Sci. 2019 Jul 25;7(14):2313-2320. doi: 10.3889/oamjms.2019.585. eCollection 2019 Jul 30.
Clinical trial NCT01020084: Salivary Flow Rate and Oral Function
Official title: Effect of Hyposalivation on Mastication and Speech
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Comminution
Jaw Movements
Keywords: Saliva
Mastication
Communication
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2009-11-25
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Forty subjects were selected (20 male and 20 female) among people seeking for dental treatment, students and staff of Piracicaba Dental School.Saliva collection was performed for all subjects, and indivuduals with normal salivary flow rate composed the control group. Hyposalivation group group, otherwise, was composed by subjects taking 0.5-0.7 mg/kg/day for at least one month prescribed by a dermatologist.

Brief summary: The purpose of this study was to investigate if salivary flow rate is important to maintain adequate oral functions.

Detailed description: Hyposalivation may damage oral functions. Therefore, the aim of this study was to evaluate whether patients under hyposalivation present damaged mastication and speech. Forty subjects composed 2 groups: Control (C) and hyposalivation (H). Masticatory performance (MP) was carried out using artificial material and a 10-sieve method. Mandibular movements during speech were obtained using a 3D jaw-tracking device. Neither mastication nor speech have been impaired by low salivary flow rate.

Eligibility criteria: Inclusion Criteria:

* Fully dentate
* Good general and oral health

Exclusion Criteria:

* Signs or symptoms of temporomandibular disorders
* Parafunctions
* Malocclusion
* History of communication deficits or prior speech-language treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Piracicaba Dental School
state: São Paulo
Study officials:
affiliation: Piracicaba Dental School
name: Renata CM Rodrigues Garcia, PhD
role: STUDY_CHAIR
affiliation: Piracicaba Dental School
name: Alrair A Del Bel Cury, PhD
role: STUDY_DIRECTOR
affiliation: Piracicaba Dental School
name: Simone G Farias Gomes, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saliva: its role in health and disease. Working Group 10 of the Commission on Oral Health, Research and Epidemiology (CORE). Int Dent J. 1992 Aug;42(4 Suppl 2):287-304. No abstract available.
citation: Bianchini EM, de Andrade CR. A model of mandibular movements during speech: normative pilot study for the Brazilian Portuguese language. Cranio. 2006 Jul;24(3):197-206. doi: 10.1179/crn.2006.032.
citation: Liedberg B, Owall B. Masticatory ability in experimentally induced xerostomia. Dysphagia. 1991;6(4):211-3. doi: 10.1007/BF02493529.
citation: Ishijima T, Koshino H, Hirai T, Takasaki H. The relationship between salivary secretion rate and masticatory efficiency. J Oral Rehabil. 2004 Jan;31(1):3-6. doi: 10.1111/j.1365-2842.2004.01033.x.
Clinical trial NCT00223184: Genetic Characterisation of High-grade Paediatric Osteosarcomas
Official title: Study of Prognostic Value by Molecular Analysis in Paediatric Osteosarcomas of the Chromosomal Regions Containing Rb, p16, p53, Cycline D1, APC, erbB2 and C-met Genes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paediatric Osteosarcomas
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-22
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under 20 years of age with primary osteosarcomas

Brief summary: At present, the only recognised prognostic factor for primary high-grade osteosarcoma is the histological response to preoperative chemotherapy. Our study was designed to identify new diagnostic markers that could eventually have a prognostic value and therapeutic consequences. 80 patients under 20 years of age with primary osteosarcomas were studied while under treatment by the French Society of Paediatric Oncology OS 94 protocol. Paired normal and biopsy samples were collected. In addition, surgical resection specimens, following preoperative chemotherapy, were obtained in many cases. After genomic DNA extraction, an allelotyping analysis targeting microsatellites was planned. The studied DNA regions contained mainly Rb, p53, APC, p16, c-met, TWIST, c-kit, erbB2 and topoisomerases genes. The techniques used in this molecular analysis comprised mainly allelotyping study, quantitative real-time PCR, gene sequencing , immunohistochemistry. The first results showed the prognostic value of 7q31 region containing c-met and 5q21 containing APC (Br J Cancer, 2003, Entz-Werlé et al.), 7p21 containing TWIST (Int J Cancer, 2005, Entz-Werlé et al.) and 4q21 targeting c-kit gene (J Clin Oncol, 2005, Entz-Werlé et al.).


Eligibility criteria: Inclusion Criteria:

* Patients under 20 years of age with primary osteosarcomas
* Under treatment by the French Society of Paediatric Oncology OS 94 protocol

Primary outcomes:
measure: Presence of molecular abnormalities statistically linked to survival or response to chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Laboratoire de Biologie Moléculaire, Hôpital de Hautepierre
city: Strasbourg
country: France
facility: Service de Pédiatrie 3, Hôpital de Hautepierre
Study officials:
affiliation: Service de Pédiatrie 3, Hôpital de Hautepierre
name: Annie BOILLETOT-BABIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01397084: To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole
Official title: An 8-week, Open Label, Multicentre Study to Assess the Efficacy of Esomeprazole 20 mg Once Daily in Subjects With Continuing Symptoms of Heartburn Following Treatment With a Previous Rabeprazole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
GERD
Reflux Esophagitis
Keywords: esomeprazole 20mg
heartburn
rabeprazole 10mg
reflux esophagitis
Phase IV
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2011-07-19
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant improvement of heartburn after 8-week treatment.


Eligibility criteria: Inclusion Criteria:

* Male of female aged 20 years or more
* History of reflux esophagitis
* Ongoing (until date of Visit 1) treatment with rabeprazole 10 mg, given once daily, for at least 4 weeks.The subject must take rabeprazole at least 4 days a week in the past 7 days prior to Visit 1.
* Persisting symptoms of heartburn experienced at least 2 days during the past 7 days prior to Visit 1.

Exclusion Criteria:

* Use of other PPIs and/or H2RA during rabeprazole treatment
* History or having other gastrointestinal diseases
* History of upper gastrointestinal surgery
* Initiation of medications that can affect digestive functions within 4 weeks before study treatment
* Inability to complete questionnaires

Primary outcomes:
measure: Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
timeFrame: Baseline and 4 weeks
measure: Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
timeFrame: Baseline and 4 weeks.
measure: Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AZ K.K.
name: Masataka Date
role: STUDY_DIRECTOR
affiliation: AZ K.K
name: Makiko Abe
role: STUDY_CHAIR
References:
Clinical trial NCT05865184: Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Official title: Feasibility of Home-based, Ambient Passive Sensor Technology to Provide Early Warning of Health Decompensation by Detecting Deviations in Activities of Daily Living (ADLs) of Elderly Subjects With Diagnosed Chronic Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Chronic Obstructive Pulmonary Disease
COPD Exacerbation
CHF
Congestive Heart Failure
Lead sponsor: Sensorum Health Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted as inpatient to Jersey Shore University Medical Center

Brief summary: Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.


Eligibility criteria: Inclusion Criteria:

* Aged 65 years or older
* Able to consent
* Documented history of diagnosis of chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF)
* Currently admitted to JSUMC for observation or as an inpatient with any diagnosis ≥1 prior hospital utilization events with any diagnosis (inpatient admissions, facility observation stays, or ED visits) in the past 12 months

Exclusion Criteria:

* Significant cardiac valvular disease
* End-Stage Renal Disease (ESRD)
* End-Stage CHF
* End-Stage COPD

Primary outcomes:
measure: Recall of AI in passive sensor system
timeFrame: 90 days
measure: Precision of AI in passive sensor system
timeFrame: 90 days
Secondary outcomes:
measure: Recall of sensor data review by trained nurses
timeFrame: 90 days
measure: Precision of sensor data review by trained nurses
timeFrame: 90 days
Other outcomes:
Locations:
city: Neptune
country: United States
facility: Jersey Shore University Medical Center, Hackensack Meridian Health
state: New Jersey
Study officials:
affiliation: Jersey Shore University Medical Center, Hackensack Meridian Health
name: Swapnel Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06519084: Home Based Program Physical Training in Congenital Heart Disease
Official title: Effect of Physical Training in Functional Capacity, Metabolic Profile, Body Composition and Quality of Life in Patients With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Functional Capacity
Body Composition
Quality of Life
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2024-07-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Previous Studies Indicate That a Substantial Proportion of the Congenital Heart Disease Patients Has Unhealthy Lifestyle Behaviors, Such as Smoking, Lack of Physical Activity, and Inadequate Dietary Patterns, Leading to the Development of Metabolic Disorders Such as Overweight/Obesity, Metabolic Syndrome, and Chronic Diseases Such as Cardiovascular Disease. Another Highly Prevalent Risk Factor in These Patients is Sedentary Behavior; These Patients Are Not Encouraged to Engage in Sports and Exercise During Childhood Due to Their Cardiac Condition, Leading to a Progressive Decrease in Physical Capacity. Studies Have Shown That Congenital Heart Disease Patients Are Not Active Enough and That a Substantial Amount of Patients is Overweight.This Study is a Randomized Controlled Trial That Investigates the Effects of the Home Based Program Physical Training, in the Exercise Capacity, Quality of Life and Body Composition.

Detailed description: The objective of the study was to verify the effect of home physical training on improving physical capacity, body composition, quality of life, metabolic markers in patients with congenital heart disease.

Eligibility criteria: Inclusion Criteria:

* Repaired congenital heart disease of all complexities
* Age ≥ 18 years
* New York Heart Association (NYHA) Class I or II
* Able and willing to participate in a 12-week cardiac rehabilitation program

Exclusion Criteria:

* Inability to give informed consent
* Inability to participate in an exercise training program
* Severe musculoskeletal disorders.
* Patient heart failure
* Patients who perform regular physical activities.
* Patients with Univentricular Physiology,
* Patients severe asthma,
* Patients with a pacemaker.
* Patients with atrial fibrillation;
* Exercise-induced arrhythmia and/or ischemia
* Cyanosis at rest
* Severe intellectual disability

Primary outcomes:
measure: Improvement exercise tolerance and functional capacity (peak VO2)
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Change in quality of life measurement
timeFrame: Baseline to 3 months
measure: Change in body composition measurement
timeFrame: Baseline to 3 months
measure: Improvement in peripheral blood flow post exercise training program
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Intitute
Study officials:
References:
Clinical trial NCT06140784: A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices
Official title: A Three-Month Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2023-11-20
Enrollment: 116
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: The primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 16 gradable teeth;
* Have mild to moderate gingivitis with at least 20 bleeding sites;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study;
* Agree to refrain from any oral hygiene the morning of your visit
* Agree to refrain from eating, drinking (except water), using tobacco, floss, use toothpicks, breath mints, or chew gum after performing your evening brushing.

Exclusion Criteria:

* Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
* Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
* Removable oral appliances;
* Fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Any diseases or condition that might interfere with the safe participation in the study; and
* Inability to undergo study procedures.

Primary outcomes:
measure: Löe-Silness Gingivitis Evaluation
timeFrame: 3 Months
Secondary outcomes:
measure: Löe-Silness Gingivitis Evaluation
timeFrame: Baseline
measure: Löe-Silness Gingivitis Evaluation
timeFrame: 1 Month
measure: Mean Turesky Modified Quigley-Hein Index
timeFrame: Baseline
measure: Mean Turesky Modified Quigley-Hein Index
timeFrame: 1 Month
measure: Mean Turesky Modified Quigley-Hein Index
timeFrame: 3 Months
Other outcomes:
Locations:
city: Whittier
country: United States
facility: UHRG
state: California
Study officials:
References: