louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01237795: Experimental Denture Pastes
Official title: A Randomized Trial of Experimental Dentifrices for Cleaning Dentures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Denture Stomatitis
Oral Candidiasis
Oral Hygiene
Keywords: Chloramine T
Complete Denture
Dental Plaque Index
Dentifrice
Denture Bases
Denture Cleansers
Edentulous Mouth
Fluorosurfactant
Oral Health
Toothpaste
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This trial aims to evaluate the efficacy of three experimental dentifrices to remove denture biofilm. Complete denture wearers will be instructed to brush their dentures with a specific toothbrush and four compositions: (1) A proprietary denture-specific paste (active comparator); (2) 0.2% chloramine T; (3) 1.0% chloramine T; (4) 0.01% fluorosurfactant. Each treatment will be used for periods of 7 days, and participants will be randomized to use them according to one of four sequences.


Eligibility criteria: Inclusion Criteria:

* Completely edentulous
* Good general health
* Patients requesting new complete dentures (volunteers will receive the interventions before new complete dentures)
* Regular wearing of the same maxillary and mandibular complete dentures for 3 to 10 years
* Both denture bases and artificial teeth should be composed by acrylic resin

Exclusion Criteria:

* Unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures)
* Absence of deposits of biofilm at baseline

Primary outcomes:
measure: Denture plaque coverage area (%)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Ribeirão Preto Dental School
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Helena FO Paranhos, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04607395: Pre-operative Radiograph of Deep Carious Lesions as a Predictive Tool for Pulpal Exposure
Official title: Pre-operative Radiograph of Deep Carious Lesions as a Predictive Tool for Pulpal Exposure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Caries
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 358
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pre-operative radiographs of deep carious lesions treated with DECAT

Brief summary: Preserving pulpal vitality is a major challenge when excavating deep caries lesions without severe symptomatology. Pulpal exposure alters success of the treatment (dropping from 93% for indirect pulp treatment with selective excavation to 11% for direct pulpotomy) and thus prognosis of dental organ and cost-effectiveness of the treatment. The preoperative x-ray is a complementary examination which allows to estimate the depth of the carious lesion. In clinical practice, it is currently difficult to accurately measure this depth on preoperative radiographs. This lack of precision leads to a decrease in the effective capacity of the operator to predict the risk of pulpal exposure. Their interpretation is considered imprecise and is not used as a diagnostic element.

The aim of this study was to determine if the use of pre-operative retroalveolar radiographs can help to predict pulpal exposure risk.


Eligibility criteria: Inclusion Criteria:

-pre-operative radiographs of deep carious lesions treated with DECAT protocole, unless they were out of the study.

Exclusion Criteria:

* Impossibility to assess carious lesion on radiograph, and amalgam restorations that impairs correct examination of carious lesion
* Radiographs of poor quality and screen captures

Primary outcomes:
measure: Measurement of residual dentin thickness and total dentin thickness on standard pre-operative radiographs
timeFrame: Outcome measure was assessed trough study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Professeur des Universités- Praticien Hospitalier
Study officials:
References:
citation: Gasqui MA, Perard M, Decup F, Monsarrat P, Turpin YL, Villat C, Gueyffier F, Maucort-Boulch D, Roche L, Grosgogeat B. Place of a new radiological index in predicting pulp exposure before intervention for deep carious lesions. Oral Radiol. 2022 Jan;38(1):89-98. doi: 10.1007/s11282-021-00530-w. Epub 2021 May 5.
Clinical trial NCT03637595: Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings
Official title: Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ostheoporosis of the Knee
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and mechanisms behind Energy Medicine in reducing chronic knee pain within an outpatient setting. This study will investigate a form of Energy Medicine (EM) performed by a natural solo practitioner, using a standard number of three sessions, which will compare to both positive and negative control groups. The positive control group will receive acupuncture and the negative control group will receive a sham intervention.


Eligibility criteria: Inclusion Criteria:

* Presence of knee pain lasting for at least six months
* No radiation of knee pain
* No acupuncture treatments in the previous six months
* Failure to respond completely to the medications given by their orthopedic or pain management specialist
* Knee pain on most days (4 out of 7 days of the week) with average self-reported severity of 4 or more out of 10 on a numeric rating scale (NRS)
* Complaints of morning stiffness lasting less than 30 minutes
* Not be in active physical therapy (PT) for the duration of the trial.
* Adult patients ≥18 years of age
* English speaking

Exclusion Criteria:

* Any concurrent diagnosis of systemic disease
* Other concurrent treatments such as massage, Acupcunture, PT or any kind of Energy Medicine
* Bleeding disorder
* Trypanophobia (fear of needles or injections).
* Have medical condition that causes difficulty in saliva production/collection (i.e.: Sjogren's Syndrome)

Primary outcomes:
measure: Pain Level measured by 11- Point Numeric Rating Scale (NRS)
timeFrame: 18 Months
measure: Pain Level measured by Visual Analog Scale (VAS)
timeFrame: 18 Months
measure: Self Reported Physical Function measured y the Western Ontario and McMaster Universities Ostheoarthritic Index (WOMAC)
timeFrame: 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Barbara A Siminovich-blok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02410395: NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique
Official title: NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique (NICUM Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Scar Niche
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Randers Regional Hospital
First posted: 2015-04-07
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this trial was to compare two different uterotomy surgical techniques on the occurrence of a uterine niche and the risk of a number of short- and long-term gynecological complications associated with the presence and size of the niche.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnant
* Intended elective cesarean section

Exclusion Criteria:

* Cervical dilatation of more than 4 cm
* Previous cesarean section

Primary outcomes:
measure: Presence of a cesarean scar niche more than 2 mm deep.
timeFrame: 6 months
Secondary outcomes:
measure: Residual myometrial thickness of the cesarean scar (RMT)
timeFrame: 6 months
measure: Cesarean scar niche depth, width, length, myometrium adjacent to the scar
timeFrame: 6 months
measure: Post-menstrual spotting
timeFrame: 15 months
measure: Incidence of cesarean scar pregnancy or spontaneous abortions
timeFrame: 72 months
measure: Adverse pregnancy outcomes in the following pregnancy
timeFrame: 72 months
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Dep. Obstetrics and Gynecology, Regional Hospital of Randers
Study officials:
affiliation: Aarhus University Hospital
name: Niels Uldbjerg, MD, DMSc
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Lone Hvidman, MD, PhD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Axel Forman, MD, DMSc
role: STUDY_CHAIR
References:
Clinical trial NCT00702195: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)
Official title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials for the Development of Org 36286 (Corifollitropin Alfa).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Neonatal outcome
Congenital malformations
In-Vitro Fertilization
Controlled ovarian stimulation
Follow-up
Ovulation Induction
Neonates
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women who became pregnant during Trials 38805 or 38807 were enrolled in Trial 38817

Brief summary: The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. Data from subjects who participated in Trials 38805 and 38807 and became pregnant were evaluated.

Detailed description: This was an open prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during any Phase IIa clinical trial of Org 36286 for OI or COH for IVF. For this trial, no study specific assessments were required, but information obtained in standard practice was used.

Eligibility criteria: Inclusion Criteria:

* Subjects taking part in any clinical development trial of Org 36286 for OI or COH for IVF in Phase IIa;
* Ongoing pregnancy confirmed by ultrasonography (USS) at or beyond 12 weeks of gestation;
* Able and willing to give written informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Pregnancy status at 20 weeks of gestation; Take-home baby rate
timeFrame: one pregnancy period
Secondary outcomes:
measure: Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities
timeFrame: one pregnancy period
Other outcomes:
Locations:
Study officials:
References:
citation: Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.
Clinical trial NCT00535795: Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
Official title: A Phase III Study to Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment of nasopharyngeal CA

Detailed description: It's a phase III study to assess conventional Rad Therapy with conventional Plus accelerated boost Rad Therapy in the treatment of nasopharyngeal carcinoma.

Eligibility criteria: Inclusion Criteria:

* Patients with nasopharyngeal Carcinoma

Exclusion Criteria:

* Patients with carcinoma other than histo-pathologically confirmed nasopharyngeal CA

Primary outcomes:
measure: safety and efficacy
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: KFSH&RC
Study officials:
affiliation: KFSH&RC
name: Nasser Al Rajhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02882295: Validation of the Zigzag Tracking Task Test for the Evaluation of Handwriting Difficulties in Writer's Cramp
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dystonic Disorder
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients suffering from writer's cramp and healthy subjects, age and gender matched

Brief summary: Writer's cramp (WC) is a task specific dystonia that occurs from the moment patient starts writing. It leads to partial or complete inability to use the hand only during the handwriting gesture. It is characterized by the appearance of cramps or spasms of certain muscles of the hand and/or forearm.

Clinical scales currently use for the assessment of WC fail to accurately reflect changes in the characteristics of handwriting in response to treatments (Botulinum Neurotoxin injections and / or retraining therapy).

The Zigzag Tracking Task (ZZTT), easy to use in current practice provides useful information in terms of speed and precision of handwriting gesture. This timed handwriting test is to follow with a pen a zigzag path beset with obstacles to avoid. It permits to evaluate the time in seconds required to carry out the zigzag path and count the number of errors (output path and contacts with obstacles). The investigators propose to validate the ZZTT for the assessment of the handwriting gesture of WC.


Eligibility criteria: Inclusion Criteria:

* scholarship in French language, at least until 16 years old
* writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders)
* prescription of botulinum neurotoxin injection
* prescription de novo or absence of injection in the last 3 months
* informed consent
* medical insurance coverage

Exclusion Criteria:

* writing tremor
* -other neurological disease with effect on handwriting
* pain or traumatism of the upper limb, with effect on handwriting
* non-corrected visual disturbances
* patient living outside the region where the study will be held (Ile-de-France)
* participation in another research with a potential impact on evaluation criteria
* pregnant or breast feeding patient
* patient under judiciary protection

Primary outcomes:
measure: hand-writing speed
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmique Adolphe de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Jean-Pierre BLETON, PhD
role: STUDY_DIRECTOR
affiliation: Fondation OPH A de Rothschild
name: Sophie SANGLA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01228695: Prospective Study of the Impact of Systemic Corticosteroid Use on Measures of Sleep Disordered Breathing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Keywords: steroids
patients treated with systemic steroids
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Israeli association for lung disease
First posted: 2010-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for long-term treatment with oral prednisone (\> 10 mg/d for 3 months or more)

Brief summary: Weight gain is both a significant risk factor for obstructive sleep apnea and a side-effect of long-term systemic steroids therapy.

This study aimed to investigate the impact of long-term systemic steroid treatment on sleep apnea.


Eligibility criteria: Inclusion Criteria:

* For inclusion, a scheduled therapy with a minimum daily dose of 10 mg prednisone (or equivalent) for at least 3 months was required

Exclusion Criteria:

* Patients younger than 18 years and those with known sleep apnea or other forms of sleep-disordered breathing were excluded

Primary outcomes:
measure: apnea-hypopnea index
timeFrame: 3 months
Secondary outcomes:
measure: sleep study variables
timeFrame: 3 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
References:
citation: Yigla M, Tov N, Solomonov A, Rubin AH, Harlev D. Difficult-to-control asthma and obstructive sleep apnea. J Asthma. 2003 Dec;40(8):865-71. doi: 10.1081/jas-120023577.
Clinical trial NCT04105595: Post Market Registry of the CBSO
Official title: Multi Centre, International, Post Market Registry to Monitor the Clinical Performance and Safety of an Atrial Septal Closure Device With Bioresorbable Framework in Patients With Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO) in Routine Clinical Use
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Septal Defect
Patent Foramen Ovale
Lead sponsor: atHeart Medical
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Intent to treat population: All enrolled patients Modified Intent to Treat population: All enrolled patients who have a permanently implanted CBSO.

Per Protocol population: All patients in the enrolled population who have a permanently implanted CBSO and do not have a major protocol deviation. The per protocol population will be used as the final population for analysis.

Brief summary: Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) in routine clinical use


Eligibility criteria: Inclusion Criteria:

* Patient suffers from ASD (including ostium secundum ASD or a fenestration from a Fontan procedure) or PFO and is planned to receive the CBSO.
* Patient (or legal guardian) has been informed and agreed to and signed the informed consent form.
* A CBSO is implanted into the patient.

Exclusion Criteria:

* Patient is known to have one or more of the contraindications listed in the instructions for use.
* Patient is currently participating in one or more interventional studies, with exception of a study investigating the CBSO.
* Patient is implanted with another product in the atrial septum.

Primary outcomes:
measure: Effective closure by echocardiography
timeFrame: at 6 months
measure: Safety throughout the follow up duration by absence of serious incidents
timeFrame: day 0 to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
Study officials:
References:
Clinical trial NCT00602095: Labour Induction With Misoprostol, Dinoprostone and Bard Catheter
Official title: A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Keywords: Labor induction
cervical ripening
misoprostol
dinoprostone
balloon catheter
prostaglandin
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 592
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised study aimed at comparing the currently most frequently used prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and randomised to one of the three methods. The main outcome measures were time to delivery, rate of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol would be superior to the other methods.

The main finding of our trial was that the catheter showed the shortest induction to delivery interval. There were no differences between the two other prostaglandins. No differences in maternal and neonatal outcome was found


Eligibility criteria: Inclusion Criteria:

* Full term singleton pregnancy with vertex presentation and with an indication for labour induction.
* Absence of active labour
* Bishop score ≤ 6.
* Normal CTG registration

Exclusion Criteria:

* Previous cesarean section
* signs of infection
* immediate need for delivery
* any contraindication for vaginal delivery

Primary outcomes:
measure: Time from treatment start to delivery
timeFrame: At delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska University Hospital Institute
name: Lena Marions, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: