louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03240341: Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway
Official title: Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Hôpital Privé de la Loire
name: Centre Hospitalier Emile Roux
name: Clinique de l'infirmerie protestante de Lyon
name: Institut de Cancérologie de la Loire
First posted: 2017-08-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim is to implement the Patient Activation Measure in paramedical practices as a tool to measure activation of patients in cancer care


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Cancer patient with an estimated life expectancy of at least one year
* Patient requiring immunotherapy or intravenous chemotherapy for any cancer according to the decision of the Multidisciplinary Consultation Meeting
* Patient affiliated or entitled to a social security scheme

Exclusion Criteria:

* Refusal to participate, protected adult patient under guardianship.
* Patient disability to understand the course of the study
* Patient with documented history of cognitive or psychiatric disorders.
* Patient not understanding French

Primary outcomes:
measure: Patient Activation Measure Questionnaire
timeFrame: 12 month
Secondary outcomes:
measure: Patient Activation Measure Questionnaire
timeFrame: 6 and 12 months
measure: Visual Analog Scale for confidence level measurement about treatment
timeFrame: 6 and 12 months
measure: Anxiety and Depression HAD Questionnaire
timeFrame: 6 and 12 months
measure: REALM Health Literacy Test
timeFrame: 6 and 12 months
measure: Quality of Life Questionnaire EQ-5D
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Lyon
country: France
facility: Clinique de l'infirmerie protestante de Lyon
city: Roanne
country: France
facility: Centre Hospitalier de Roanne
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
city: Saint-Étienne
country: France
facility: Hôpital Privé de la Loire
Study officials:
affiliation: CHU de Saint-Etienne
name: Pierre Fournel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verot E, Bouleftour W, Macron C, Rivoirard R, Chauvin F. Effect of PARACT (PARAmedical Interventions on Patient ACTivation) on the Cancer Care Pathway: Protocol for Implementation of the Patient Activation Measure-13 Item (PAM-13) Version. JMIR Res Protoc. 2020 Dec 8;9(12):e17485. doi: 10.2196/17485.
Clinical trial NCT03340441: Prizma Device Temperature Measurement
Official title: Clinical Evaluation for Body Temperature Measurement Using Prizma Smart Phone Cover and Application
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Temperature Change, Body
Lead sponsor: G Medical Innovations Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-13
Enrollment: 300
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalised adults of which the total number of febrile subjects shall not be less the 30% and not greater than 50% of all subjects.

Brief summary: The purpose of the study is to evaluate the temperature measurements by the Prizma device.

Detailed description: Primary objective of this study is to compare the temperature measured by the PRIZMA to the oral and Armpit temperature measured by a gold standard device in order to develop and evaluate a skin to body temperature conversion table.

Secondary objective is to collect and compare data of ECG, Respiration and SpO2 collected from the Prizma device to the data collected from gold standard devices for reference of noise level and for future development of the PRIZMA device.

Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Age above 18 years from both genders
* ASA physical status 1-4
* Hospitalized in internal ward

Exclusion Criteria:

* Abuse of alcohol or illicit drugs
* History of mental retardation or any mental disease
* Skin irritation / Atopic dermatitis or any other skin condition at the area of patients palms that might affect his/her ability to hold the device appropriately

Primary outcomes:
measure: Temperature measurement
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rishon leZion
country: Israel
facility: Asaf Harofe Medical Center
Study officials:
affiliation: Asaf Harofe Medical Center
name: Moshe Tishler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01422941: Safety and Performance of the CAVU Medical, Inc. Attune Tubing Study
Official title: A PROSPECTIVE, MULTI-CENTER CLINICAL EVALUATION TO ASSESS SAFETY AND PERFORMANCE OF CAVU MEDICAL, INC.'S ATTUNE TUBING WHEN USED WITH NEWLY-IMPLANTED LAPAROSCOPIC ADJUSTABLE GASTRIC BANDS (LAGBs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Cavu Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-25
Enrollment: 40
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 objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.


Eligibility criteria: Inclusion Criteria:

1. The subject is at least 18 years of age.
2. The subject has been informed of the nature of the trial and agrees to its provisions.
3. The subject has a pre-implantation BMI within the protocol limits.
4. The subject agrees to the follow-up visit schedule.
5. The subject is a candidate for a LAGB procedure.
6. The subject agrees to comply with specified follow-up evaluations.
7. The subject is willing to fast for 2 hours prior to each adjustment visit.

Exclusion Criteria:

1. The subject is pregnant or is not willing to use an effective method of birth control for the duration of the trial.
2. The subject has a condition that is contraindicated for LAGB procedures.
3. The subject is currently using weight loss medications or supplements.
4. The subject has a concurrent terminal medical condition with a life expectancy of less than 12 months.
5. The subject is currently participating in an investigational drug or another medical device trial.
6. The subject had a previous LAGB procedure.
7. The Investigator believes that the patient has physical or mental conditions that would render trial participation inappropriate.

Primary outcomes:
measure: The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events.
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Baulkham Hills
country: Australia
facility: Institute of Weight Control
state: New South Wales
city: Kogarah
country: Australia
facility: St. George Private Hospital
state: New South Wales
Study officials:
affiliation: Institute of Weight Control
name: Anthony Brancatisano, B Appl Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01467141: Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes
Official title: Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 26
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Treatment with insulin for at least 6 months prior to inclusion
* HbA1c below or equal to 11.0 %
* Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion

Exclusion Criteria:

* The receipt of any investigational drug within one month prior to this trial
* Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
* Total daily insulin doses at least 1.80 IU/kg
* Treatment with oral hypoglycaemic agents
* Known or suspected allergy to trial product or related products

Primary outcomes:
measure: Incidence of hypoglycaemic episodes during the treatment
timeFrame: Week 0; week 24
measure: Change in HbA1c (glycosylated haemoglobin A1c)
timeFrame: Week 0; week 24
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Week 0; week 24
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Hagen
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
city: Osnabrück
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Danne T, Rastam J, Odendahl R, Nake A, Schimmel U, Szczepanski R, Moeller J, Deiss D. Parental preference of prandial insulin aspart compared with preprandial human insulin in a basal-bolus scheme with NPH insulin in a 12-wk crossover study of preschool children with type 1 diabetes. Pediatr Diabetes. 2007 Oct;8(5):278-85. doi: 10.1111/j.1399-5448.2007.00261.x.
Clinical trial NCT03350841: Pain After PRP Revascularization and Endodontic Treatment of Non-vital Mandibular Molars With Apical Periodontitis
Official title: Evaluation of Post-operative Pain Following Platelet Rich Plasma (PRP) Revascularization Versus Conventional Endodontic Treatment of Non-vital Mature Mandibular Molars With Chronic Peri-apical Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 36
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: randomized clinical trial which Evaluate thr Post-operative Pain Following Platelet Rich Plasma (PRP) Revascularization versus Conventional Endodontic Treatment of Non-vital Mature Mandibular Molars with Chronic Peri-apical Periodontitis

Detailed description: it will be done in 2 visits where in the firist visit, i will finish cleaning and shaping of the canals and inject double antibiotic paste as intracanal medication.

in the second visit, removal of intracanal medication then obturaton of the canals in the control group. while in the intervention group,over instrumentation of the canals beyond the working length using k-file size 20-35 to establish bleeding in the canals.then blood sample is collected for PRP preparation then injected into the canal.the patient will record post operative pain 6,12,24,48 hours then 3,4,5 days later.then they will do CBCT at 6, 12 months after the treatment to assess peri-apical healing

Eligibility criteria: Inclusion Criteria:

* Medically free patients, between 18-40 years
* Patients with necrotic pulp in mandibular molar permanent teeth with closed apex

Exclusion Criteria:

* Illiterate patient
* Patients with systemic diseases
* Pregnant women
* Patients that have allergy to ciprofloxacin or metronidazole
* Teeth that:

  * Have vertical root fracture, coronal perforation, and calcification.
  * re-treatment cases
  * Non restorable
* Patients that have T.M.J. disorder

Primary outcomes:
measure: Post-operative Pain
timeFrame: 5 days
Secondary outcomes:
measure: healing
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Yassmin Elsayed Ahmed
Study officials:
References:
Clinical trial NCT05313841: Novel Equation for Estimating Intraperitoneal Pressure
Official title: Novel Equation for Estimating Intraperitoneal Pressure in Patients on Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraperitoneal Pressure
Peritoneal Dialysis
Equation
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All peritoneal dialysis patients meet the inclusion and exclusion criteria in a single center

Brief summary: Intraperitoneal Pressure is associated with the complications of increased intra-abdominal pressure in peritoneal dialysis patients. Due to the complicated operations, routine measurement of hydrostatic intraperitoneal pressure is not used routinely in adult peritoneal dialysis patients. There ars some limitions in equations from previous studies, such as the sample size was small , and the study population was limited. In the study, we aim to develop and validate an equation for estimating intraperitoneal pressure in peritoneal patients.


Eligibility criteria: Inclusion Criteria:

* Peritoneal dialysis patients
* Dialysis length \>1 month
* Aged 18-80 years
* Injection volume of peritoneal dialysis solution\>1500ml

Exclusion Criteria:

* Acute complications （ peritonities, cardiovascular and cerebrovascular diseases) to hospitalization 1 month prior to the study
* History of abdominal surgery and trauma 1 month prior to the study
* Previous history of hernia, leakage, or thoracoabdominal fistula
* Can't come for a follow-up visit

Primary outcomes:
measure: Novel equation development
timeFrame: July 17, 2021 to September 30, 2021
measure: Novel equation validation
timeFrame: October 1,2021 to October 31,2021
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jie Dong
state: Beijing
Study officials:
References:
Clinical trial NCT05316441: Positive Psychotherapy in Adolescents on Achievement Motivation
Official title: The Effect of Achievement Skill Development Psychoeducation Based on Positive Psychotherapy in Adolescents on Achievement Motivation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Behavior
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research was designed in an experimental model with an intervention-control group. The sample of the research; It consists of 60 students (30 controls, 30 experiments) with 80% power, 95% confidence interval and 0.05 margin of error.
Primary purpose: OTHER

Brief summary: The aim of this study is to determine the effect of success skill development psychoeducation based on Positive Psychotherapy on the achievement motivation of adolescents.

Detailed description: The foundation of positive psychotherapy (PPT) Prof. Dr. It was cast by Nossrat Peseschkian. Psychodynamic approaches, existential-humanistic approaches, cultural therapy approaches and behavioral approaches are used in therapy. Positive Psychotherapy states that people have two basic abilities, namely loving and knowing.

In line with the ability to love, primary abilities (love, modeling, relationship/contact, time, patience, trust, belief/religion, doubt, certainty, sexuality, hope and integrity) are formed; In line with the ability to know, secondary abilities (punctuality, orderliness, cleanliness, obedience, courtesy, honesty, loyalty, justice, hard work/success, frugality and reliability) are formed, which are behavioral categories.

These real abilities develop with family, society, environment and time and become the character of the person, and the degree of whether or not the real abilities are in the person plays a decisive role in both the individual's own mental state and interpersonal relations. The ability to succeed, which is one of the secondary abilities, is extremely important for people to have goals and passions in life.

The two most important components of a successful learning-teaching process are providing learner motivation and ensuring the learner's behavioral, sensory and cognitive participation in this process.

Considering that a significant decrease in achievement motivation is observed especially in adolescents with advancing age, the achievement motivation levels of learners against course processes emerge as an important requirement.

Eligibility criteria: Inclusion Criteria:

Being a high school student. Having equipment and internet to attend group sessions. Volunteer to work.

Exclusion Criteria:

Not having the equipment and internet to attend group sessions. Not being willing to work.

Primary outcomes:
measure: Achievement Motivation
timeFrame: Change = Pre-psychoeducational assessment (Time 1), immediately after psychoeducation (Time 2).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00782041: Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer
Official title: Phase II Study of Oxaliplatin in Combination With 5-fluorouracil (5-FU) and Folinic Acid (FA) in Patients Who Have Failed First-line Treatment for Locally Advanced or Metastatic Cervical Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Uterine Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 11
Sex: FEMALE
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: Primary:

* To assess the overall response rate of oxaliplatin in patients with bidimensionally measurable disease at baseline.

Secondary:

* To assess the safety and tolerability of oxaliplatin
* To assess time to progression and overall survival.


Eligibility criteria: Inclusion Criteria:

* Have Locally advanced/metastatic squamous or adenocarcinoma of the cervix
* Prior therapy with cisplatin allowed
* First-line treatment may have been surgery,radiotherapy or chemotherapy either as a single agent or multi-modality therapy
* Must have measurable disease
* Histologically Proven Carcinoma of the cervix
* ECOG PS ≤2
* No other serious concomitant illness
* Fully recovered from any prior therapy
* Lab: ANC \>1500 mm³, Platelets \> 100000 mm³, Creatinine ≤ 1.5 x Normal value, Bilirubin ≤ 1.5 x Normal value, SGPT (ALT) ≤ 2.5 x Normal value

Exclusion Criteria:

* Known allergy to one of the study drugs
* Peripheral neuropathy \> grade2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Response rate
timeFrame: Throughout the study period
Secondary outcomes:
measure: Progression-free survival
timeFrame: Throughout the study period
measure: Overall survival
timeFrame: Throughout the study period
measure: Adverse events
timeFrame: Throughout the study period
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sanofi aventis administrative office
Study officials:
affiliation: Sanofi
name: Paibulsirijit Sompob, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05761041: Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries
Official title: Effectiveness of Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Early Childhood Caries
Keywords: ECC
38% SDF
5% NaF
Motivational Interviewing
Preschoolers
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Science, Technology & Innovation Funding Authority (STDF)
First posted: 2023-03-09
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for the management of early childhood caries (ECC). However, black staining is one of its drawbacks. A possible affordable alternative can be Sodium Fluoride (NaF) supported with good oral hygiene induced by parental Motivational Interviewing (MI).

The trial aims to compare the impact of SDF versus NaF supported by MI on lesion activity in preschool children.


Eligibility criteria: Inclusion Criteria:

1. Children aged ≤ 4 years old.
2. The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
3. Children whose caregivers have means of communication (mobile phones).
4. Completion of an informed consent to participate in the study.

Exclusion Criteria:

1. Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess.
2. Parental refusal to participate in the study.
3. Allergy or sensitivity to silver or any of the materials included in the study.

Primary outcomes:
measure: Caries Arrest
timeFrame: 6 months
Secondary outcomes:
measure: Caries Increment
timeFrame: 6 months
measure: Parental satisfaction
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
References: