louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06117696: Optimizing the Announcement of Advanced or Metastatic Prostate Cancer Using Animated Videos (CartDiag PROSTATE)
Official title: Optimizing the Announcement of Advanced or Metastatic Prostate Cancer Using Animated Videos (CartDiag PROSTATE)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Keywords: prostate cancer advanced or metastatic
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with newly diagnosed advanced or metastatic prostate cancer

Brief summary: In hospitals, the standard prostate cancer announcement system is based on oral and written information. To improve this system, we have developed animated videos that retrace the patient's care path.

This is an exploratory, controlled, before-and-after, multicenter study designed to assess the effect of a standard announcement system reinforced by animated videos on patients' level of understanding of prostate cancer diagnosis and treatment. Patients' perception of information will be assessed using the EORTC QLQ-INFO25 questionnaire.


Eligibility criteria: Inclusion Criteria:

1. Collection of the patient's non-opposition prior to participation in the study.
2. Patient aged ≥ 18 years at inclusion.
3. Patient with newly diagnosed advanced or metastatic prostate cancer.
4. Patients due to start systemic therapy.
5. Patients undergoing consultation.
6. Patient affiliated to a social security scheme.
7. Patient capable, according to the physician-investigator, of communicating well, understanding and complying with the requirements of the study.
8. Patient with a smartphone or computer to review the video at home.

Exclusion Criteria:

1. Patient related to any member of the study staff or having a close relationship or conflict of interest with the sponsor.
2. Patient to receive only local treatment.
3. Patient who does not understand French.
4. Clinical follow-up impossible for psychological, family, social or geographical reasons.
5. Vulnerable patient: deprived of liberty by judicial or administrative decision, adult subject to legal protection or unable to express non-opposition.

Primary outcomes:
measure: EORTC QLQ-INFO25 score
timeFrame: Through study completion (30 days)
Secondary outcomes:
measure: EORTC QLQ-INFO25 score differences
timeFrame: Through study completion (30 days)
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: Clinique Hartmann
city: Saint-Mandé
country: France
facility: HIA Bégin
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU Pointe-à-Pître
Study officials:
References:
Clinical trial NCT00471796: A Comparison of Factors of Symptoms Generation and Evaluation of Role of Biofeedback in Patients With Different Types of Functional Esophageal Disorders (Functional Heartburn and Functional Chest Pain)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chest Pain
Heartburn
Keywords: Patients with functional chest pain and functional heartburns
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-05-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is supposed that patients with functional esophageal disorders such as functional heartburns and functional chest pain have common underlying mechanisms of symptom generation. These include esophageal dysmotility, non-acidic gastro-esophageal reflux, duodeno-gastro-esophageal reflux, esophageal hypersensitivity, and psychological comorbidity.

The treatment of these patients is the growing challenge in the primary care medicine and in the gastroenterological practice. It was postulated that functional disorders of the esophagus are the main reason for PPI failure in patients with heartburn.

The aim of the study is to evaluate the role of biofeedback in the treatment of patients with functional chest pain and functional heartburns.


Eligibility criteria: Inclusion Criteria:

1. Men and women ages 18-75.
2. Willing to participate and sign an inform consent.
3. Having heartburns, acid regurgitations and/or chest pain at least twice a week for at least 3 months.
4. Ability to stop anti-acid and anti-pain medications for at least two weeks.

Exclusion Criteria:

1. History of upper gastrointestinal surgery.
2. Concomitant diseases that may affect esophageal perception (diabetes mellitus, neuropathy).
3. Concomitant medications that may affect esophageal perception (anti-inflammatory, anti-depressants drugs).
4. Pregnancy.
5. Severe conditions such as cardiac failure, renal failure and other that may be contraindication for upper endoscopy.
6. Erosive esophagitis on upper endoscopy or pathological result of ambulatory 24-hour pH monitoring.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Michael Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171496: Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients
Official title: A Six-month Open Label, Multicenter, Randomized Study to Evaluate the Incidence of New Onset Diabetes Mellitus and Glucose Metabolism in Patients Receiving Cyclosporine Microemulsion With C-2 Monitoring Versus Tacrolimus After de Novo Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant
Keywords: Kidney transplant, adults, NODM, immunosuppressants
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection


Eligibility criteria: Inclusion Criteria:

- First or second transplant, cadaveric or living donor

Exclusion Criteria:

* Multi-organ or dual kidney transplants
* Panel reactive antibodies \>50%

Other protocol-defined inclusion/exclusion criteria applied

Primary outcomes:
measure: Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation.
measure: Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.
Secondary outcomes:
measure: incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus
measure: percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation
measure: Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation
measure: percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation
measure: incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT)
timeFrame: 6 months
measure: Blood pressure at Months 3& 6 post-transplantation
measure: incidence of BPAR or graft loss or death within the first 3 months post-transplantation, as well as the incidence of each individual event within 3 and 6 months post-transplantation.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Ekmekcioglu O, Turkan S, Yildiz S, Gunes ZE. Comparison of tacrolimus with a cyclosporine microemulsion for immunosuppressive therapy in kidney transplantation. Turk J Urol. 2013 Mar;39(1):16-21. doi: 10.5152/tud.2013.004.
Clinical trial NCT05661396: Therapeutic Serious Game and Rehabilitation of Stroke Patient
Official title: Development of a Therapeutic Serious Game in the Rehabilitation of Stroke Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Unilateral Spatial Neglect
Keywords: serious game
stroke
unilateral spatial neglect
rehabilitation
Lead sponsor: Hopitaux de Saint-Maurice
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 6
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 growing field of new technologies offers new perspectives for neurorehabilitation. Serious games are a promising solution in the rehabilitation of cognitive impairments, and they may be useful in the rehabilitation of unilateral spatial neglect. The investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency.

Six patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Three patients assigned to the experimental group received both serious game training and conventional rehabilitation, and three assigned to the control group received only conventional rehabilitation. The investigators compared the two groups after rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Unilateral spatial neglect syndrome
* Right cerebral lesion

Exclusion Criteria:

* Epilepsia
* General mental deterioration
* Psychiatric disorder
* No prior history of neurological disease

Primary outcomes:
measure: Bells test
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Bisection of lines
timeFrame: up to 4 weeks
measure: Ogden scene copying
timeFrame: up to 4 weeks
measure: Reading task
timeFrame: up to 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03164096: The Effect of Some Parturients' Characteristics on Sensory Block Level After Spinal Anesthesia
Official title: The Effect of Body Mass Index, Intra-abdominal Pressure, Abdominal Girth and Waist Circumference on Sensory Block Level After Single-shot Spinal Anesthesia for Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia, Obstetrical
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: evaluating relationship of sensory level and other patient factors
Primary purpose: SCREENING

Brief summary: Although the exact mechanism remains unknown, the association of pregnancy and decreased local anesthetic requirement is clear. demonstrated that more local anesthetic is required for cesarean section under combined spinal-epidural anesthesia in preterm compared with term patients.

Detailed description: However, in pregnant patients, venous engorgement is prominent in the supine but not the lateral position, which suggests direct compression of the inferior vena cava by the gravid uterus. Second, an increase in intraabdominal pressure may affect the retroperitoneal area and may cause inward movement of soft tissue in the intervertebral foramina. Recent magnetic resonance imaging studies in pregnant patients, although without intraabdominal pressure measurements, suggested the latter because they showed limited contact of engorged veins along the dural sac which may therefore not be responsible for compression of the dura.

If elevated intraabdominal pressure contributes to high anesthetic spread during pregnancy, one would expect a relationship between intraabdominal pressure and maximum sensory block level.

Eligibility criteria: Inclusion Criteria:

* adult female partner
* aged 18 to 40 years.
* scheduled for elective cesarean section.

Exclusion Criteria:

* Patients with coagulopathy or under anti-coagulation therapy.
* Gastrointestinal disease,
* motion sickness.
* diabetes mellitus.
* Patients with preeclampsia,

Primary outcomes:
measure: sensory level
timeFrame: from allocation until 24 hours post-operative
measure: motor block
timeFrame: from allocation until 24 hours post-operative
Secondary outcomes:
measure: hypotension
timeFrame: from allocation until 24 hours post-operative
measure: vasopressor consumption
timeFrame: from allocation until 24 hours post-operative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut governorate
Study officials:
References:
Clinical trial NCT06190496: Cervical Volume and Prediction of Preterm Labor
Official title: Role of Cervical Volume and 3 D Power Doppler Indices for Prediction of Preterm Labour
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Preterm Labor
Cervical Volume
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women in the second trimester knowing last menstrual period and history of regular menses at Women's Health Hospital Assuit University

Brief summary: The primary aim of this research is to assess the predictive value of 3D cervical volume and 3D power Doppler indices in predicting pregnancies at risk of preterm labor.

Secondary aim: to compare 2D cervical length and 3D cervical length in coronal view for predicting preterm labour.


Eligibility criteria: Inclusion Criteria:

1. Age : 18-35 years old
2. Singleton pregnancy
3. Gestational age : 18-26 Ws knowing last menstrual period and history of regular mense.

Exclusion Criteria:

1. Multiple gestations (e.g., twins, triplets).
2. History of cervical surgery or cervical cerclage.
3. Known uterine anomalies that could affect cervical assessment.
4. Contraindications for transvaginal ultrasound, such as active vaginal bleeding or infection.
5. Severe fetal anomalies or conditions incompatible with life

Primary outcomes:
measure: The primary outcome could be the incidence of preterm birth (i.e., births occurring before 37 weeks of gestation) among the study participants.
timeFrame: Baseline
Secondary outcomes:
measure: 1. Gestational Age at Delivery: Measure the gestational age at which participants in the study give birth. This information can help assess whether ultrasonic assessments correlate with the timing of delivery.
timeFrame: Baseline
measure: 2. Predictive Parameters: Analyse the individual and combined predictive power of cervical length, vascularity indices, and cervical volume. Determine which of these parameters (or their combinations) show the strongest correlation with preterm birth
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00141596: Extracellular Fluid in Resistant Hypertension
Official title: A Study to Investigate the Contribution of Extracellular Fluid Volume Expansion to Drug Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: Resistant Hypertension
Extracellular Fluid Volume
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2005-09-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The optimal treatment of drug resistant (defined as BP\> 140/85 despite three anti-hypertensive drugs including a diuretic) is not well defined. This study aims to test the hypothesis that resistant hypertension is caused by excessive expansion of extracellular fluid volume. A secondary objective is to study which of three different antihypertensive drugs would be most useful in drug resistant hypertension.

Detailed description: Following recruitment subjects will have ECV measured by 51Cr-EDTA determination of GFR, with Brochner-Mortensen correction applied. Subjects then receive the following drugs, in a randomised fashion, for a period of four weeks each, with BP \& ECV measurement at end of each period: doxazosin GITS (Cardura XL) 4 mg b.d.; frusemide 40 mg b.d.; amiloride 5 mg b.d.; placebo.

Eligibility criteria: Inclusion Criteria:

* BP \>140/85
* 3 antihypertensive drugs (ACE/ARB + calcium channel blocker + thiazide diuretic)

Exclusion Criteria:

* Pregnancy
* Breast Feeding
* Unstable heart failure
* Chronic Liver Disease
* Creatinine \>120 mcmol/L
* Contraindication to (or intolerance of) drug used in study
* BP \> 180/110

Primary outcomes:
measure: Change in ECV; change in BP
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Blood Pressure Unit, Dept. Cardiac & Vascular Sciences, SGUL
Study officials:
affiliation: SGUL
name: Timothy WR Doulton, BSc MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04471896: Joovvin' for Your Skin Health Study
Official title: Examining the Impact of Infrared Light Therapy Device on Cosmetic Skin Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Inflammation
Acne
Skin Diseases
Dermatological Non-Disease
Skin Condition
Eczema
Lead sponsor: ProofPilot
Sponsor class: INDUSTRY
Collaborators: name: Joovv
First posted: 2020-07-15
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sixty day single arm trial examining self-report and remote dermatology assessment of cosmetic skin health after daily 10-20 minute sessions with an infrared light therapy device (the Joovv Mini)


Eligibility criteria: Inclusion Criteria:

* willingness to use device for 60 days
* willingness to place security deposit on device of $149.99
* US resident with an address than can accept UPS deliveries
* 18 years old
* no serious medical conditions
* no medically treatable skin diseases
* willingness to take a selfie with mobile phone

Exclusion Criteria:

* Retinoid use
* prior use of light therapy within the past 6 months
* pregnant or nursing
* dietary supplements for skin, hair or nail health

Primary outcomes:
measure: Blinded Dermatology Assessment of Facial Skin Health
timeFrame: 60 day
measure: Changes in Self-Report Skin, Hair & Nail Health and Satisfaction
timeFrame: 60 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: ProofPilot (Virtual Study: https://p.proofpilot.com)
state: New York
Study officials:
References:
Clinical trial NCT06417996: Biobeat Digital Home Monitoring Feasibility
Official title: Postoperative Digital Care Home Monitoring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Surgery
Home Monitoring
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To assess the feasibility of evaluating postoperative home monitoring with Biobeat digital monitoring. The investigators hypothesize that the Biobeat digital home monitoring platform will lead to a decrease in unplanned visits to the ED (Emergency Department). In addition, patients' quality of life is postulated to be improved compared to patients receiving the current standard of care without home monitoring.

Detailed description: This trial will be a single centre, parallel arm, randomized controlled feasibility trial. The investigators will evaluate postoperative home monitoring with the Biobeat digital monitoring and two-way communication through the digital portal for 4 weeks post-operatively to the standard of care (no digital monitoring) in thoracic surgery patients undergoing elective thoracic surgical procedures. The investigators will assess whether conducting a larger randomized trial of digital home monitoring vs. standard of care is feasible in terms of recruitment, data collection and logistics.

Eligibility criteria: Inclusion Criteria:

* Patient willing to provide informed consent
* Wi-fi or cellular connectivity at the patient's home
* Patient undergoing elective lung cancer surgery
* Patient familiar/comfortable with the use of technology such as online banking.

Exclusion Criteria:

- Patients who are not comfortable with the use of technology.

Primary outcomes:
measure: To assess whether conducting a larger randomized trial of digital home monitoring vs. standard of care is feasible in terms of recruitment, data collection and logistics.
timeFrame: 365 days
Secondary outcomes:
measure: Number of ED Visits
timeFrame: 30 days from discharge
measure: Readmission Rates
timeFrame: 30 days from discharge
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT04061096: Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization
Official title: Effectiveness Of Local Anesthesia In Molar Teeth With Molar Incisor Hypomineralization-A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molar Incisor Hypomineralization
Keywords: Anesthesia
Cold test
Electrical pulp test
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare responses to electrical pulp test (EPT) and cold test among molar incisor hypomineralization (MIH)-effected and not MIH-effected carious teeth before and after administration of local anesthesia for caries removal.

Detailed description: Fifty carious permanent first molar teeth (25 MIH-effected, 25 not MIH-effected) were included. Firstly, radiographic caries depth, International Caries Detection and Assessment System (ICDAS) codes and MIH levels of teeth were recorded. Then, during the treatment, EPT and cold test were performed before and after the administration of local anesthesia. Visual Analog Scale for Pain was used to evaluate cold test and pain during treatment. When interpreting results, significancy level was stated for the values of p\<0.05.

Eligibility criteria: Inclusion Criteria:

* Healthy participants

Exclusion Criteria:

* Not being cooperative during treatment procedure

Primary outcomes:
measure: Cold test results
timeFrame: Time frame of cold test evaluation was aproximately 1 hour for each participant.
measure: Electrical pulp test results
timeFrame: Time frame of electrical pulp test evaluation was aproximately 1 hour for each participant.
measure: Pain during the treatment
timeFrame: Pain during the treatment was evaluated for aproximately 1 hour for each participant.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baskent University
name: Didem Sakaryali, Asst.Prof.
role: PRINCIPAL_INVESTIGATOR
References: