louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06534294: Effect of Non-pharmacological Anti-anxiety Exercises on Perceived Stress and Cortisol Level Before Elective Per Cutaneous Transluminal Coronary Angioplasty
Official title: Effect of Non-pharmacological Anti-anxiety Exercises on Perceived Stress and Cortisol Level Before Elective Per Cutaneous Transluminal Coronary Angioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Transluminal Coronary Angioplasty
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Effect of non-pharmacological anti-anxiety exercises on Perceived Stress and cortisol level before elective percutaneous transluminal coronary angioplasty

Detailed description: patients will be selected from national heart institute their age from 30 -50 years old. Patients will be assigned randomly into 4 groups 15 in each group, reflexology group, deep breathing group, combined group (reflexology and deep breathing) and control group. Before procedure two tools will used to collect data (demographic characteristics format the beginning once and Distress Thermometer scale before and 30 minutes after application in all groups ) in addition blood samples (5 mL) will take from all the patients on an empty stomach between 08:30 and 10:00 in the morning and 30 minutes after the application to determine the cortisol level in all groups

Eligibility criteria: Inclusion Criteria:

* Fully conscious patients, aged from 30 to 50 years.
* will do percutaneous transluminal coronary angioplasty for the first time without any problem of communication.
* accepting to give Blood samples available between 08:30 and 10:00 in the morning (to avoid differences in cortisol levels), and agreeing to participate in the study

Exclusion Criteria:

* having myocardial infarction symptoms,
* unconscious, having a surgery in the last 6 weeks,
* previously diagnosed with a psychiatric disorder or still having a psychiatric disease, using anxiety medication (psychotropic), corticosteroid, using estrogen or amphetamine derivative drugs,
* infection of the lower extremities, having varicose veins, having peripheral neuropathy and deep vein thrombosis or risk of development, high fever,

Primary outcomes:
measure: Cortisol Levels
timeFrame: At subject enrollment "single session"
measure: Distress Thermometer
timeFrame: At subject enrollment "single session"
Secondary outcomes:
Other outcomes:
Locations:
city: Sadat
country: Egypt
facility: Al Ryada University for Science and Technology
state: Menofia
Study officials:
References:
Clinical trial NCT05469594: Second-trimester TOP : a Retrospective Study Comparing Complications at 12-14 vs 14-16 Weeks of Gestation
Official title: Second-trimester Termination of Pregnancy: A Retrospective Study Comparing Complications Related to Termination of Pregnancy at 12-14 Weeks' Gestation Versus 14-16 Weeks' Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abortion in First Trimester
Abortion, Second Trimester
Keywords: complications
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women of childbearing age, major, with a single pregnancy who underwent for termination of pregnancy for medical reasons (maternal or foetal) between 12 and 16 weeks of gestation.

Brief summary: In France, the recently adopted law relating to the legal time limit for access to voluntary interruption of pregnancy has set a threshold of the term at which it can be performed up to 16 weeks of gestation. This single-centre study conduced at the Nancy Maternity Hospital is based on a retrospective cohort of all patients who underwent a medical termination of pregnancy between January 2010 and October 2021. The main objective is to evaluate the complications according to the term of the termination of pregnancy between two groups : \[12-14\] vs \[14-16\] weeks of gestation. The secondary objective is the distribution of these complications between the two groups. Pregnancy termination can be performed in two methods, either by medical method with mifepristone and misoprostol, or by surgical method by dilation and evacuation. Complications identified are haemorrhage, infection, retained product of trophoblast, uterine rupture and abortion induction failure. The hypothesis is the concomitant increase in complications with the term of the termination of pregnancy.


Eligibility criteria: Inclusion Criteria:

* termination of pregnancy for a medical reason
* between 12 and 16 weeks of gestation
* singleton pregnancy

Exclusion Criteria:

* multiple pregnancy
* abortion occurred before the induction of termination of pregnancy

Primary outcomes:
measure: complications
timeFrame: Day 0
Secondary outcomes:
measure: repartition of all complications
timeFrame: Day 0
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03910894: Health-related Quality of Life in Colon Cancer
Official title: Health-related Quality of Life in Colon Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Related Quality of Life
Lead sponsor: Region Västmanland
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 376
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with colon cancer in Region Västmanland 2012-2016, that accepted to be included in the study after written consent.

Brief summary: This study investigates health-related Quality of life in colon cancer patients in Västmanland, Sweden, at diagnosis, at 6 months, 1, 2 and 3 years after diagnosis, measured by the well-validated EORTC QLQ-C30 questionnaire.

Detailed description: See above.

Eligibility criteria: Inclusion Criteria:

All patients diagnosed with colon cancer in Region Västmanland 2012-2016.

Exclusion Criteria:

Language problems, declined inclusion,

Primary outcomes:
measure: Health-related Quality of Life
timeFrame: 2012-2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Region Västmanland
name: Catarina Tiselius, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tiselius C, Rosenblad A, Strand E, Smedh K. Risk factors for poor health-related quality of life in patients with colon cancer include stoma and smoking habits. Health Qual Life Outcomes. 2021 Sep 10;19(1):216. doi: 10.1186/s12955-021-01850-5.
Clinical trial NCT00905294: Study of ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Coronary Artery Disease
Official title: ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Patients Undergoing Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: Royal College of Surgeons, Ireland
First posted: 2009-05-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease undergoing percutaneous coronary intervention

Brief summary: The purpose of this research is to determine the relationship between proteins and enzymes in the blood and how they work with platelets to form blood clots in patients with coronary artery disease. The investigators hypothesize that the relationship between these factors could potentially be useful in identifying patients at higher risk for heart attacks.


Eligibility criteria: Inclusion Criteria:

* Admission to hospital with suspected index event of Non-ST-Elevation Myocardial Infarction (NSTEMI), Unstable Angina (UA) or Stable Angina (SA)
* Planned percutaneous coronary intervention during admission

Exclusion Criteria:

* Recent history (\< 6 months) of an acute coronary syndrome (other than current admission) or stroke
* Recent history (\< 6 months) of major surgery, trauma or thromboembolic event
* Percutaneous coronary or peripheral intervention or any stent placement performed within the past 6 months
* Current evidence of infection

Primary outcomes:
measure: relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels
timeFrame: change from baseline to after percutaneous coronary intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: University College Cork, Ireland
name: Noel M. Caplice, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal College Surgeons in Ireland
name: Dermot Kenny, M.D.
role: STUDY_DIRECTOR
affiliation: Beaumont Hospital, Dublin, Ireland
name: David Foley, M.B.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00220194: A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer
Official title: A Six-Month, Open-Label, Crossover Study Of the Maintenance Of Serum Testosterone And PSA Suppression After Switching Between Lupron 22.5 Mg And Eligard 22.5 Mg Or Zoladex 10.8 Mg And Eligard 22.5 Mg In Patients With Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer of Prostate
Lead sponsor: San Bernardino Urological Associates Medical Group Inc
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparing the effect of switching from Lupron and Zoladex to Eligard. PSA and Testosterone levels are measured at set intervals to determine if Eligard is equal or better then Lupron or Zoladex in advanced Prostate Cancer patients.


Eligibility criteria: Inclusion Criteria: Patient with Advanced Ca, on stable dose of Lupron or Zoladex

-

Exclusion Criteria:

* Previous exposure to Eligard.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Bernardino
country: United States
facility: San bernardino Urological Associates Medical Group
state: California
Study officials:
affiliation: San Bernfardino Urological Associates
name: Franklin M Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05833594: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma
Official title: Anhui Provincial Hospita
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Squamous Cell Carcinoma
Chemoradiotherapy
Immunonutrition
Inoperable
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 18-85 years old;
* Eastern Cooperative Oncology Group (ECOG) 0-2;
* Esophageal squamous cell carcinoma;
* cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;
* initial unresectable at initial diagnosis confirmed by thoracic surgeons;
* Treatment naive;
* No contraindications for adjuvant chemoradiotherapy;
* Signature of inform consent.

Brief summary: Chemoradiotherapy has been a standard modality for inoperable locally advance esophageal carcinoma. The goal of this randomized control study is to compare the feasibility, and survival benefits of whole-course immunonutrition combined with chemoradiotherapy±ICIs for local advanced patients with inoperable esophageal squamous cell carcinoma. The main questions it aims to answer are: • If the feasibility and safety of whole-course immunonutrition combined with chemoradiotherapy±ICIs is better. • If the survival benefits (1, 2 and 3-years progression free survival) of whole-course immunonutrition combined with chemoradiotherapy±ICIs is longer. The Experimental group will receive a combination immunonutrition of omega-3 fatty acids, and glutamine, whereas the control group will receive standard formula.


Eligibility criteria: Inclusion Criteria:

* 18-85 years old;
* Eastern Cooperative Oncology Group (ECOG) 0-2;
* Esophageal squamous cell carcinoma;
* cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;
* initial unresectable at initial diagnosis confirmed by thoracic surgeons;
* Treatment naive;
* No contraindications for adjuvant chemoradiotherapy;
* Signature of inform consent.

Exclusion Criteria:

* younger than 18 years old or older than 85 years old;
* ECOG\>2;
* Esophageal adenocarcinoma, small-cell cancer and other pathological types;
* cT1anyNM0, cT4banyNM0, c anyTanyNM0 confirmed by radiological examination;
* Resectable at initial diagnosis confirmed by thoracic surgeons;
* Previous treatment of chemotherapy, radiotherapy, and other treatment;
* Contraindications for chemoradiotherapy;
* No signature of inform consent.

Primary outcomes:
measure: Rate of adverse events
timeFrame: 1 month post treatment
measure: Disease Control Rate
timeFrame: 1 month post treatment
Secondary outcomes:
measure: 1-, 2-, 3-year Progression-free survival rate (PFS).
timeFrame: 1 to 3 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui provincial hospital
Study officials:
References:
Clinical trial NCT06129994: Ecological Momentary Assessment Study of Adolescents and Young Adults With Type 1 Diabetes (EMA-T1D)
Official title: Ecological Momentary Assessment Study of Adolescents and Young Adults With Type 1 Diabetes (EMA-T1D)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2023-11-13
Enrollment: 150
Sex: ALL
Minimum age (years): 13
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must meet eligibility criteria to be enrolled

Brief summary: This single site investigator-initiated prospective observational study will enroll up to 150 participants 13-26 years of age with Type 1 diabetes (T1D) and utilize ecological momentary assessment methods (EMA) to examine associations between different diabetes psychological domains (distress, anxiety, and depression) in real-time on self-efficacy, self-management behaviors, and glycemic outcomes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 diabetes for at least six months
* Fluent in spoken and written English
* Willing to carry around their mobile phone during the home monitoring period with daily access to cellular or WiFi connectivity
* Willing to wear a continuous glucose monitor (CGM) device during the home monitoring period

Exclusion Criteria:

* Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation
* Skin conditions or diseases that would interfere with the CGM sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
* Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor or insulin pump removal) that cannot be scheduled around or accommodated within the study assessment windows
* Currently pregnant or plan to become pregnant during participation in the study

Primary outcomes:
measure: Ecological Momentary Assessment (EMA) methods for measuring diabetes distress
timeFrame: Home monitoring (days 1-14)
measure: Ecological Momentary Assessment (EMA) methods for measuring anxiety
timeFrame: Home monitoring (days 1-14)
measure: Ecological Momentary Assessment (EMA) methods for measuring depression
timeFrame: Home monitoring (days 1-14)
Secondary outcomes:
measure: Glycemic Outcomes
timeFrame: Home monitoring (days 1-14)
measure: Hemoglobin A1c
timeFrame: Baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jennifer Iyengar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01369394: Making Decisions About the Measles-Mumps-Rubella Vaccine
Official title: Developing a Computer-based Intervention That Provides Individually-tailored Educational Information for MMR Vaccine-hesitant Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Measles
Mumps
Rubella
MMR Vaccination
Keywords: Measles
Mumps
Rubella
MMR
Prevention
Tailoring
Persuasive communication
Children
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-06-08
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to determine whether a computer-based intervention that delivers individually-tailored educational messages about the MMR vaccine increases MMR vaccine-hesitant parents' intentions to have their children vaccinated.

Detailed description: This will be a randomized controlled intervention trial for MMR vaccine-hesitant parents of children ages six years and younger who have not yet received the MMR vaccine. Parents will complete a three-item measure that assesses their baseline intentions for having their children vaccinated with MMR. Participants will then fill out a short, computer-based survey that assesses demographic factors, prior experience with MMR, and views about a variety of potential barriers to MMR vaccination. Following the survey, the intervention group (40 parents) will view a series of tailored educational messages resembling web pages that uses their survey data to address at an individual level their specific concerns about the MMR vaccine. The control group (40 parents) will view a series of generic educational messages resembling web pages that is similar in appearance to the intervention, but contains only untailored information about the vaccine. After navigating through these educational messages, MMR vaccination intention will be reassessed using the same three-item measure as for the baseline assessment of vaccination intention. The vaccine administration records of the children of these parents will be accessed after parents' participation in the study to assess whether the MMR vaccine was provided to the child.

Eligibility criteria: Inclusion Criteria:

* Parent is greater than or equal to 18 years of age
* Parent has a child 6 years of age or younger
* When asked to describe how he/she feels about getting child vaccinated against MMR, parent responds "I don't want to get my child vaccinated" or "I'm unsure if I want my child to get vaccinated"

Exclusion Criteria:

* Cannot read/speak English

Primary outcomes:
measure: Parent's intention to vaccinate child against MMR
timeFrame: Date of intervention (one day)
Secondary outcomes:
measure: Use of the intervention
timeFrame: At the time of intervention participation
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: UMHS Outpatient Pediatrics
state: Michigan
Study officials:
affiliation: Children's Outcomes Research Program
name: Amanda Dempsey, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04416594: Impact of Acquired FXIII Deficiency on Morbidity and Mortality
Official title: Impact of Acquired FXIII Deficiency on Morbidity and Mortality Among Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Factor XIII Deficiency Disease
Keywords: Factor XIII
Blood transfusion
Mortality
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical and surgical hospitalized patients

Brief summary: Observational prospective study aiming to assess acquired FXIII deficiency implications in morbidity and mortality

Detailed description: All patients admitted to a large tertiary hospital with FXIII levels below 70% during their hospital stay are assessed. Data regarding patient background, blood transfusion, morbidity and mortality is registered.

Eligibility criteria: Inclusion Criteria:

* FXIII levels \< 70%

Exclusion Criteria:

* None

Primary outcomes:
measure: Cut-Point levels of FXIII
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gregorio Marañon Hospital
Study officials:
References:
citation: Duque P, Chasco-Ganuza M, Ortuzar A, Almaraz C, Terradillos E, Perez-Rus G, Pascual C. Acquired FXIII Deficiency is Associated with High Morbidity. Thromb Haemost. 2022 Jan;122(1):48-56. doi: 10.1055/a-1481-2733. Epub 2021 Jun 6.
Clinical trial NCT02214394: Detection of Propofol in Exhaled Breath
Official title: Propofol in Exhaled Breath: Real-time Detection by Surface Acoustic Wave Sensors.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Xhale Assurance
Sponsor class: INDUSTRY
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2014-08-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study involves the use of an experimental device which will measure how much propofol is present in your exhaled breath during surgery compared to how much is in your blood. The study results will look at whether the device is as accurate as conventional methods for measuring propofol levels during surgery.


Eligibility criteria: Inclusion Criteria:

* Be between 18 and 65 years old
* Healthy Male or Female
* BMI between 18.5 and 30.0
* Have a planned surgery or other medical procedure requiring anesthesia
* Physical status ASA I, II, or III

Exclusion Criteria:

* Known allergy to any component of propofol formulation components
* History of lung disease or tobacco use in the past 5 years
* Any finding not detailed above encountered on medical history or during screening physical and clinical laboratory examinations that, in the investigators judgment, might place the subject at unacceptable risk for injury during study participation

Primary outcomes:
measure: Comparison of propofol concentrations in exhaled breath to those in plasma
timeFrame: Sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: Xhale, Inc.
name: Donn M Dennis, M.D., F.A.H.A.
role: STUDY_DIRECTOR
References: