louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01110148: Use of Portable Technology in Patient Education of Shave/Punch Biopsies
Official title: Use of MP3 Portable Technology in Patient Education and Informed Consent of Shave and Punch Biopsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biopsy
Keywords: skin biopsy
informed consent
patient education
video education
patients requiring skin biopsies
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2010-04-26
Enrollment: 84
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: The investigators investigated the use of portable MP3 technology in patient education and informed consent of shave and punch biopsies. Eighty patients were divided randomly into a control and experimental group. Control patients received the standard of care in patient education and informed consent. Experimental patients watched a short 80-second video on shave or punch biopsies. All patients were given pre- and post-education questionnaires to assess the efficacy of each method.


Eligibility criteria: Inclusion Criteria:

* English speaker
* Receiving shave or punch biopsy

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: Measure the post-education knowledge of each intervention arm
timeFrame: at the end of the study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: UC Davis Health System
name: April W Armstrong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02040948: Accuracy of Pulse Pressure Variation and of Pleth Variability Index to Predict the Response to a Fluid Challenge
Official title: Accuracy of Pulse Pressure Variation (Nexfin) and of Pleth Variability Index (Radical 7) to Predict the Response to a Fluid Challenge: Comparison With the Reference Method (Measurement of Stroke Volume by Esophageal Doppler)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Responsiveness
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 68
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 of this study is to compare the accuracy of Pleth Variability Index (Radical 7 device) and of Pulse Pressure Variation (Nexfin device) with the Doppler measurement of stroke volume (esophageal Doppler) to detect the response to a fluid challenge.


Eligibility criteria: Inclusion Criteria:

* patients undergoing major abdominal surgical procedures performed by laparotomy
* patients undergoing major urological surgical procedures performed by laparotomy
* patients undergoing major gynecological surgical procedures performed by laparotomy
* age ≥ 18 years
* signed informed consent

Exclusion Criteria:

* pregnant women
* esophageal disease
* aortic valve disease
* allergy to gelatin
* BMI \> 35
* beta blocker treatment, antiarrhythmic treatment, arrhythmia, pace-maker,
* presence of an arterio-venous shunt or of any other vascular disease on upper limb

Primary outcomes:
measure: Ability of Pleth Variability Index and of Pulse Pressure Variation to detect the response to a fluid challenge
timeFrame: during the intraoperative period
Secondary outcomes:
measure: Inability to obtain Pleth Variability Index or Pulse Pressure Variation indices
timeFrame: during the intraoperative period
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hopital Beaujon
state: Hauts de Seine
city: Suresnes
country: France
facility: Hopital Foch
state: Hauts de Seine
Study officials:
References:
Clinical trial NCT00630357: Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy
Official title: A Phase IV, Open-label, Multi-center Trial to Evaluate the Safety and Efficacy of Keppra® After Conversion to Mono-therapy in Adult Subjects With Partial Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Levetiracetam
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 14
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A cohort of patients who became seizure-free during add-on treatment to one standard AED with Keppra in a previous trial (N01031) were followed to assess whether seizure freedom was maintained. Tolerability was documented.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of epilepsy with partial seizures;
* having completed the trial N01031 of Keppra as adjunctive therapy (SKATE);
* seizure-free over the last 3 months prior to protocol Visit 1;
* 1 concomitant marketed AED at the time of trial entry and throughout the previous trial N01031;
* on the clinical judgment of the Investigator, progressive withdrawal of the concomitant AED and conversion to monotherapy with Keppra can be attempted.

Exclusion Criteria:

* History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous 5 years;
* presence of known pseudoseizures within the last year;
* presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
* felbamate with less than 18 months exposure;
* vigabatrin, without visual field assessment as per recommendation of the manufacturer, i.e., every 6 months;
* uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.

Primary outcomes:
measure: Investigate seizure freedom with Keppra flexible dose.
Secondary outcomes:
measure: Tolerability and safety.
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06475157: Artificial Intelligence-enhanced Electrocardiogram Diagnoses and Predicts Future Regurgitant Valvular Heart Diseases
Official title: Artificial Intelligence-enhanced Electrocardiogram Diagnoses and Predicts Future
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electrocardiogram, Valvular Heart Disease
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An overall population.

Brief summary: This is a retrospective study to establish models for the prediction of future valvular heart diseases with artificial intelligence-enhanced electrocardiogram (ECG).


Eligibility criteria: Inclusion Criteria:

* Subjects that received ECG and echocardiography tests during a date frame.

Exclusion Criteria:

* Subjects who is younger than 18 years of age.

Primary outcomes:
measure: Progression of valvular heart diseases
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
city: London
country: United Kingdom
facility: Hammersmiths Hospital
Study officials:
References:
Clinical trial NCT04621357: Influence of Cerebral Oedema in Intracerebral Haemorrhage
Official title: Consequences of Oedema on the Prognosis of InTraCerebral Haemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Intra Cerebral Hemorrhage
Keywords: Intra Cerebral Hemorrhage
Perihaematomal oedema
MRI
outcome
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Conseil Régional Hauts-de-France, France
name: Fondation pour la recherche sur les AVC
First posted: 2020-11-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In 2020, IntraCerebral Haemorraghe (ICH) remains the most devastating type of stroke. Besides stroke unit care, no specific treatment has been proven effective yet. Perihaematomal oedema (PHO) could be a promising therapeutic target. However, the mechanisms, the natural history as well as the clinical impact of this PHO remain unclear. The COPITCH study has been designed to answer these questions


Eligibility criteria: Inclusion Criteria:

* With a spontaneous ICH, i.e. non traumatic
* Admitted within 12 hours of stroke onset. For wake-up strokes, time of last seen well will be considered as stroke onset
* Patient insured under the French social security
* Consent form signed

Exclusion Criteria:

* Pure intraventricular haemorrhages
* "secondary" ICH: ICH resulting from intracranial vascular malformation, intracranial venous thrombosis, head trauma or tumour; haemorrhagic transformation within an infarct
* Pre-admission modified Rankin score of 4 or 5
* Life expectancy of less than 1 year related to comorbidities (end stage cancer, end stage organ failure)
* Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done)
* Adults who are deprived of their liberty by judicial or administrative decision
* Referral from other hospitals
* Contra-indication to MRI : claustrophobia, ocular metallic foreign bodies (accidental or other) or in a risk area (nervous or vascular system);irremovable implanted medical device (pacemaker, neurostimulator, cochlear implants and others);metallic heart valve (mainly old heart valves) or vascular clips previously implanted on cranial aneurysms; gadolinium allergy
* No consent form

Primary outcomes:
measure: Poor functional outcome defined as a modified Rankin Scale of 4 or more
timeFrame: at 3 months
Secondary outcomes:
measure: overall distribution of the modified Rankin scale at 3- and 12 months
timeFrame: at 3 months and 12 months
measure: Early neurological deterioration defined as more than 4 points on the NIHSS score
timeFrame: at 96 hours
measure: all-cause mortality at 3 and 12 months
timeFrame: at 3 and 12 months
measure: Cognitive decline
timeFrame: at 3 months, at 12 months
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Charlotte Cordonnier, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01267357: P16 Staining as Prognostic Biomarker in Serous Papillary Endometrial Cancer
Official title: Expression of the P16 Protein in Serous Papillary Endometrial Cancer, and Its Clinical and Prognostic Significance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Serous Papillary Endometrial Cancer
Keywords: Serous Papillary Endometrial Cancer
Endometrioid endometrial cancer
biomarkers
P16
P53
Prognosis
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-12-28
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women diagnosed with endometrial cancer, having undergone surgery and having received chemotherapy in our institution.

Brief summary: P16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma. Evidence from previous trials indicates that it may be used as a diagnostic biomarker distinguishing this disease from endometrioid endometrial cancer. Additional evidence points to its prognostic value.

The current study will evaluate p16 both as a diagnostic tool for serous papillary endometrial cancer and as a prognostic biomarker.

following anonymization, histology blocks will be microtomed and stained for P16 and P53 proteins.

Blocks from endometrioid endometrial cancer will be used as a control group.


Eligibility criteria: Inclusion Criteria:

* diagnosis of endometrial cancer
* histology block exists in hospital's library

Exclusion Criteria:

* none

Primary outcomes:
measure: Overall survival
timeFrame: last followup (2-10 years)
Secondary outcomes:
measure: progression free survival
timeFrame: Current follow up (2-10 years)
measure: correlation of P16 stain with histological diagnosis
timeFrame: at last follow up (2-10 years)
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References:
Clinical trial NCT03820557: Decision Counseling Program in Increasing Shared Decision Making and Clinical Trial Participation in Patients With Stage 0-IV Lung Cancer (Free to Breathe)
Official title: Increasing Shared Decision Making and Patient Participation in Lung Cancer Clinical Trials (Free to Breathe)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial studies how well the Decision Counseling Program works in increasing patient-physician shared decision making and participation in clinical trials for lung cancer patients. Decision aids help provide patients with information that may help them select a course of action related to their cancer care when more than one alternative is available. It also encourages shared decision making allowing patients and their providers to make health decisions together. Determining how patients make decisions about participating in a clinical trial may help doctors facilitate patient decision making and improve participation in lung cancer clinical trials.

Detailed description: PRIMARY OBJECTIVES:

I. Facilitate patient deliberation about participation in a lung cancer clinical trial using the Decision Counseling Program (DCP).

SECONDARY OBJECTIVES:

I. Document the extent to which patient values and preferences are incorporated into physician-patient shared decision making (SDM) about cancer clinical trials.

II. Assess changes in patient knowledge, anxiety, and decisional conflict related to clinical trial participation.

III. Characterize patient and physician experience with intervention exposure.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with lung cancer (Stages 0, 1, 2, 3, 4)
* Lung cancer patients for which there is an available interventional clinical trial open at Jefferson Kimmel Cancer Center
* Patients being treated by a lung medical oncologist on the Center City Campus of Thomas Jefferson University
* Able to provide informed consent
* English-speaking

Exclusion Criteria:

* Inability to communicate in English
* Unable to provide informed consent
* Not eligible for an open, actively accruing interventional trial at Jefferson

Primary outcomes:
measure: Patient perception related to clinical trials participation, measured by follow up survey questions
timeFrame: Baseline to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Amy Leader, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01932957: Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy
Official title: A RANDOMISED TRIAL COMPARING LAPARASCOPY VERSUS LAPAROTOMY IN THE MANAGEMENT OF WOMEN DIAGNOSED WITH ECTOPIC PREGNANCY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ruptured Ectopic Pregnancy
Keywords: Laparoscopy
Ruptured ectopic pregnancy
Lead sponsor: University of Pretoria
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Standard management for patients with ruptured ectopic pregnancies at our institution is treatment by laparotomy. This trail will investigate the feasibility of treatment with laparoscopy and will look at outcomes such as hospital stay and pain experienced

The hypothesis is that laparoscopy is a feasible treatment option associated with shorter hospital stay and less pain

Detailed description: Laparoscopic surgery for the surgical management of women diagnosed with ectopic pregnancies has become the standard of care in many institutions around the world. Laparotomy is still the standard of care at Kalafong Hospital. There is very little high quality evidence with regard to the optimal surgical management approach for women with ruptured ectopic pregnancies.

The study aims to compare laparotomy with laparoscopy in this group of women with regards to outcomes such as length of hospital stay, number of days off work and pain.

This randomised study will be conducted at Kalafong hospital, on 140 patients diagnosed with ruptured ectopic pregnancy who are haemodynamically stable and are able and willing to provide informed consent.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Able to give informed consent
* must have two of the following three:
* systolic blood pressure \>90 mmHg
* pulse rate \<100 beats per minute
* heamoglobin \>8 g/dL

Exclusion Criteria:

* \<18 years
* haemodynamically unstable
* not able to give informed consent

Primary outcomes:
measure: Hospital stay
timeFrame: 5 days
Secondary outcomes:
measure: Pain scores
timeFrame: 24 hours
measure: Theatre time
timeFrame: 1 day
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: Kalafong Academic Hospital
state: Gauteng
Study officials:
affiliation: Principal Specialist, Department Obstetrics & Gynaecology, University of Pretoria
name: Leon C Snyman, MBChB FCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05743257: How Urban Interventions in Lower Socioeconomic Areas Influence Health Behaviors (UrbASanté Study)
Official title: The UrbASanté Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Health-Related Behavior
Lead sponsor: Paris 12 Val de Marne University
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: University Gustave Eiffel
name: National Research Agency, France
First posted: 2023-02-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Porte de la Chapelle (Paris, France)

Brief summary: The UrbASanté study is a quasi-experimental research that aimed at assessing the impact of urban transformations (a natural experiment) in the health related behaviors, environmental exposure and perceived- health.

Detailed description: The UrbASAnté study is an interdisciplinary project evaluating the relationships between urban transformations (urban regeneration programs) and health related behaviors, environmental exposure (air pollution, noise) and health (perceived) in a deprived neighborhood in Paris (France).

UrbASanté consists of quasi-experimental research (before/after protocol design) and includes an "exposed" group of inhabitants living in a neighborhood with urban transformation (intervention) and an "unexposed group" comprising inhabitants from neighborhood not undergoing urban changes (control).

Participants will be surveyed at enrollment and 24 months later.

Eligibility criteria: Inclusion Criteria:

* Living in areas with urban intervention in Porte de la Chapelle, Paris (for experimental group)
* Living in areas without direct urban interventions close to Porte de la Chapelle, Paris (for control group)
* Age above 18 years

Primary outcomes:
measure: Change in the mean adequacy ratio (MAR)
timeFrame: at baseline and 24 month later
measure: Change in the mean excess ratio (MER)
timeFrame: at baseline and 24 month later
measure: Change in physical activity behaviors
timeFrame: at baseline and 24 month later
measure: Change in sedentary behaviors
timeFrame: at baseline and 24 month later
measure: Change in perceived health
timeFrame: at baseline and 24 month later
Secondary outcomes:
measure: Age (in year) of each member of the household
timeFrame: at baseline
measure: Gender of adult members of the household
timeFrame: at baseline
measure: Household income
timeFrame: at baseline
measure: Education level of each adult of the household
timeFrame: at baseline
measure: Living duration (in month/year) in the residential neighborhood
timeFrame: at baseline
measure: Marital status
timeFrame: at baseline
Other outcomes:
Locations:
city: Créteil
country: France
facility: Université Paris Est Créteil
Study officials:
affiliation: Paris 12 Val de Marne University
name: Helene Charreire
role: PRINCIPAL_INVESTIGATOR
affiliation: University Gustave Eiffel
name: Benoit Conti
role: PRINCIPAL_INVESTIGATOR
References: