louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06476548: Mindfulness-Based Ecological Momentary Intervention For Smoking Cessation Among Cancer Survivors
Official title: Mindfulness-Based Ecological Momentary Intervention For Smoking Cessation Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Any Cancer Type
Keywords: Smoking Cessation
Cancer Survivor
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-06-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of the study is to obtain feedback on a new quit-smoking treatment among individuals with a cancer diagnosis using a prototype app we developed.

Detailed description: The study aims to test the usability of the prototype app in conjunction with face-to-face brief cessation counseling and nicotine replacement therapy in a single-arm trial.

Eligibility criteria: Inclusion Criteria:

* Having smoked at least one cigarette (even one or two puffs) within the past 30 days.
* Having been diagnosed with cancer.
* Willing to give quitting a try as part of the study.
* Having a smartphone that allows installation of the app.
* Willingness to download and use the app daily.
* Valid home address and functioning phone number.
* Being able to read, write, and speak English.

Exclusion Criteria:

* Being enrolled in a smoking cessation program.
* Current use of smoking cessation medications.
* Evidence of current psychosis.
* Current/planning pregnancy or lactation.

Primary outcomes:
measure: Open-ended feedback
timeFrame: At 4 weeks
measure: Utility of mindfulness practices
timeFrame: At 4 weeks
measure: Likability of mindfulness practices
timeFrame: At 4 weeks
measure: Retention rate
timeFrame: At 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Christine Vinci, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Min-Jeong Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01554748: Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
Official title: Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: total joint arthroplasty
thumb
trapeziometacarpal joint
osteoarthritis
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Implantation of TMC total joint arthroplasty in a patient cohort
Primary purpose: TREATMENT

Brief summary: The study evaluates implant survival in total joint arthroplasty of the Trapeziometacarpal (TMC) joint by monitoring the survival of different implant types using radiostereometry (RSA) evaluation of the implants.

Detailed description: The study evaluates implant survival and clinical outcome in total joint arthroplasty of the TMC joint. Different implant designs are included in the study both cemented and uncemented implants. Also the influence of patient factors and surgical technique on implant survival is investigated. The primary outcome is implant migration and loosening. Evaluation is done by monitoring migration and loosening of different implant types using RSA evaluation of the implants. Secondary outcomes are patient reported function evaluated with the Disability of the arm, shoulder and hand score (DASH) and visual analog pain score (VAS). Tertiary outcome is range of movement (ROM) plus grip strength.

Eligibility criteria: Inclusion Criteria:

* Patients with Eaton type 2+3 TMC osteoarthritis

Exclusion Criteria:

* Patients with Eaton type 4 TMC osteoarthritis

Primary outcomes:
measure: Implant survival
timeFrame: 10 year survival
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Orthopaedics, Regional Hospital Holstebro
Study officials:
affiliation: Orthopaedic Research Unit Regional Hospital Holstebro
name: Torben B. Hansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mosegaard SB, Stilling M, Hansen TB. Risk factors for limited improvement after total trapeziometacarpal joint arthroplasty. Health Qual Life Outcomes. 2020 Mar 30;18(1):90. doi: 10.1186/s12955-020-01333-z.
Clinical trial NCT01965548: Treatment of Splenic Trauma: a Retrospective Cohort Study
Official title: Treatment of Splenic Trauma: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Splenic Injury
Keywords: spleen
injury
patient transfer
splenectomy
embolization, theurapeutic
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 109
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a traumatic splenic injury admitted at University Hospital North Norway Tromsø

Brief summary: In blunt trauma, the spleen is most frequent injured organ in the abdomen and the most frequent source of bleeding in the abdomen.

Historically, splenectomy was the treatment of choice for splenic bleeding. For exsanguinating patients, open splenectomy is still the proper choice of treatment if the spleen is a significant source of bleeding. However, for hemodynamic stable patients with splenic injury, non-operative management (NOM) is an alternative, assuming they have no other indication for surgery (peritonitis).

Non-operative management includes observation and/or splenic artery embolisation (SAE), but the indications for observation and SAE varies between trauma centers. The greatest advantage of NOM is the preservation of splenic function.

In the investigators hospital splenic artery embolisation was introduced in 2007. The investigators want to describe the treatment of splenic injuries in their hospital, to see if the number of splenectomies has been recduced after 2007, and to see if SAE has also been used in transferred trauma patients.


Eligibility criteria: Inclusion Criteria:

* All patients admitted at UNN Tromsø in the period of 01.01.2000 - 31.12.2013 and with the discharge diagnosis S36.0 Splenic injury (ICD-10)

Exclusion Criteria:

* no injury/coding error
* iatrogenic injury
* transfer \>7 days after injury
* \>10 days between injury and first hospital admission

Primary outcomes:
measure: type of splenic trauma treatment
timeFrame: 0-7 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 1 - 90 days
measure: Length of stay in the intensive care unit
timeFrame: 0 - 90 days
measure: Emergency procedures
timeFrame: 0 - 7 days
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital North Norway Tromsø
Study officials:
affiliation: University Hospital og North Norway
name: Trond Dehli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dehli T, Bagenholm A, Trasti NC, Monsen SA, Bartnes K. The treatment of spleen injuries: a retrospective study. Scand J Trauma Resusc Emerg Med. 2015 Oct 29;23:85. doi: 10.1186/s13049-015-0163-6.
Clinical trial NCT03324048: A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System
Official title: A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Relaxation
Keywords: Preoperative anxiety
Relaxation
Autonomous nervous system
Surgery
Visual Analogue Scale (VAS)
State-Trait Anxiety Inventory (STAI-Y)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Anxiety is an emotional disorder. It's a painful concern caused by uncertainty. It is a complex phenomenon misunderstood in spite of medical progress. Relaxation is a technical for reduce anxiety and is effective and safe. Previous study demonstrated the impact of session relaxation on the autonomous nervous system by the heart rate variability.

Primary objective of this new study is to demonstrate a link between heart rate variability and reduced anxiety during relaxation session.

Detailed description: It is monocentric, prospective and interventional study. This study will be proposed at the patients who will have an orthopedic surgery in full hospitalization. These patients are anxious because of surgery too. The day before surgery anesthetist save heart rate variability and value of the partial pressure of carbon dioxide during relaxation session.

Eligibility criteria: Inclusion Criteria:

* Affiliated or entitled to a social security
* Have signed consent before their participation in the study
* Aged over 18 years
* Patients who will have an orthopedic surgery in full hospitalization
* Patients anxious on visual analogic scale of anxiety (\>5)

Exclusion Criteria:

* Different disorder : disability to understand instructions, respiratory insufficiency, obesity, sleep apnea, wearing a pacemaker
* Medical history of schizophrenia or bipolar disorder

Primary outcomes:
measure: high frequency
timeFrame: continuously during the relaxation session
Secondary outcomes:
measure: anxiety
timeFrame: after the relaxation session at day 1
measure: low frequency
timeFrame: continuously during the relaxation session
measure: the ratio of high frequencies to low frequencies
timeFrame: continuously during the relaxation session
measure: PetCO2
timeFrame: continuously during the relaxation session
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Zeina PRADES, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00360048: Oxytocin Effects on Cytokines and Endocrine Parameters After LPS Induced Systemic Inflammatory Effects in Healthy Volunteers
Official title: Oxytocin Effects on Cytokines and Endocrine Parameters After LPS Induced Systemic Inflammatory Effects in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: oxytocin
tnf
sepsis
lps
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-08-03
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The aim of this study is to determine if oxytocin administration is able to blunt LPS induced increase of cytokines (TNF-α) and if there is a change in the endocrine response after lipopolysaccharide administration in humans.


Eligibility criteria: Inclusion Criteria:

* Men aged 18 years or older with no disease history
* Written informed consent

Exclusion Criteria:

* Receiving any medication
* Probands who suffer from infectious disease

Primary outcomes:
measure: TNF-alpha
timeFrame: six hours
Secondary outcomes:
measure: ACTH, cortisol, procalcitonin, IL-1ra, IL-4, IL-6, MIP-1alpha, MIP-1 beta, MCP-1, IP-10, VEGF, body temperature, BNP, Ghrelin,
timeFrame: six hours
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Martin Clodi, MD, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vila G, Riedl M, Resl M, van der Lely AJ, Hofland LJ, Clodi M, Luger A. Systemic administration of oxytocin reduces basal and lipopolysaccharide-induced ghrelin levels in healthy men. J Endocrinol. 2009 Oct;203(1):175-9. doi: 10.1677/JOE-09-0227. Epub 2009 Jul 8.
Clinical trial NCT04002648: Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?
Official title: Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barlow's Disease
Prolapse; Mitral
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe MR due to the prolapse of both leaflets in the context of Barlow's disease submitted to EE repair via a video-assisted right minithoracotomy (minithoracotomy group) and patients with Barlow's disease treated with surgical mitral repair with the EE technique through a conventional median sternotomy (sternotomy group).

The diagnosis of Barlow's disease was made during a preoperative transoesophageal echocardiographic (TEE) examination and confirmed by the surgeon's direct assessment of the valve. All patients had excessive leaflet tissue, annular dilatation and bileaflet prolapse. Cases with a forme fruste of Barlow's disease were excluded.

Brief summary: The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.


Eligibility criteria: Inclusion Criteria:

Patients treated for bileaflet prolapse in Barlow's Disease between 1997 and 2011

Exclusion Criteria:

Age inferior to 18 years

Primary outcomes:
measure: Cardiac Death
timeFrame: 12 years
measure: Severe MR
timeFrame: 12 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.
Clinical trial NCT04405648: Computer Vision Syndrome Prevalence Among University Students
Official title: Prevalence and Severity of Computer Vision Syndrome Among Medical Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Computer Vision Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: medical students who are using screens in their medical studies or personal lives and how these screens affect their medical studies and the effect of mandated medical computer use if present on their screen-behaviour and associated risk factor

Brief summary: CVS-F3 questionnaire will be used as an instrument to survey CVS prevalence and severity among medical students

Detailed description: CVS-F3 is a valid questionnaire that includes 26 questions to be responded by the medical students to detect CVS complains and possible complications. The questionnaire includes questions regarding potential ocular, extra-ocular, musclo-skeletal and neuro-psychatric complains caused by CVS. Complete statistical analysis of the survey data will be done using univariate and multivariate logistic and linear regression analysis.

Eligibility criteria: Inclusion Criteria:

* university students
* studying medicine

Exclusion Criteria:

* ocular surgery
* amblyopia
* anisometropia
* strabismus
* DM
* hypertension

Primary outcomes:
measure: Prevalence of CVS
timeFrame: 1 month
measure: Visual acuity
timeFrame: 1 month
measure: Refraction
timeFrame: 1 month
measure: Schirmer test
timeFrame: 1 month
measure: Tear Break Up Time (TBUT)
timeFrame: 1 month
measure: mfERG examinations
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
affiliation: Sohag University
name: Mohammed Iqbal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04085848: Music Against Psychological Pain in Suicide
Official title: A Controlled, Randomized Study Evaluating the Effecacy of Receptive Music Therapy on Psychological Pain in Suicidal Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide, Attempted
Suicidal Ideation
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study compares the efficacy of music therapy associated with standard care versus the standard care alone on the psychological pain in suicidal patients.

Detailed description: Music therapy consists of using the Music Care tool. Each patient randomized in the music therapy arm should perform 4 music therapy sessions of 30 minutes on 48h.

Before and after each music therapy sessions, the psychological pain will be measured by the analogical visual scale.

Standard care consists of a medical and paramedical interview lasting 20-30 minutes. At the end of the interview, a drug treatment (BZD anxiolytic and/or hypnotic) is prescribed and the patient is hospitalized. During hospitalization, patient is regularly interviewed in order to evaluate his psychological status.

Eligibility criteria: Inclusion Criteria:

* Patient with suicidal ideas, thoughts or surviving suicide attempt
* Patient whose emergency somatic management lasted less than 48h
* Patient who, according to the physician, is still in suicidal mood
* Patient admitted in the psychiatric hospitalization unit of the Public Mental Health Establishment
* Patient with voluntary admission and agrees to stay in hospital from 48h to 60h
* Patient able to write and read in french
* Patient affiliated to a social security scheme
* Patient who gives his Informed consent before any procedure related to the study

Exclusion Criteria:

* Patient with attempt suicide requiring a somatic care (intensive, surgery, gastric lavage...)
* Patient with medical history of audiogenic and/or musicogenic epilepsy
* Patient with major impairment of hearing function
* Patient unable to support the headhset earphone
* Patient with contra indication to BZD, hypnotics (Zopiclone) or requiring more sedative and/or psychotic drugs
* Patient under guardianship or under judicial protection
* Patient hospitalized at the request of a third party or ex officio

Primary outcomes:
measure: Change from inclusion psychological pain at 48 hours after inclusion
timeFrame: 48 hours after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Paul
country: Réunion
facility: Etablissement Public de Santé Mentale de La Réunion
Study officials:
affiliation: EPSMR
name: Erick GOKALSING
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02937948: Adaptative Radiotherapy for Locally Advanced Cervical Cancer
Official title: Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Cancer
Keywords: Locally advanced
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy.


Eligibility criteria: Inclusion Criteria:

* Cervix carcinoma proved by histology
* According International Federation of Gynecology and Obstetrics (FIGO) classification, stages IB2, IIA, IIB, IIIA and IIIB without lumbo-aortic lymph node damage (surgical or radiologic)
* Patient treated with radio-chemotherapy then curietherapy with curative aim, validated in multidisciplinary meeting
* Renal, hepatic and cardiovascular functions that allow administration of the associated systemic treatment
* Older than 18 years
* Good general status, World Health Organization less or equal to 1
* Signed informed consent

Exclusion Criteria:

* History of cancer that is not controlled and / or treated for less than 5 years (excepted for cutaneous baso-cellular cancer)
* History of pelvic irradiation
* Simultaneous participation to another research that could interfere with the study results
* Pregnant or breastfeeding patient
* Patient under tutor or guardian
* Patient not able to respect medical follow-up for geographical, social or psychological reasons
* Not affiliated to a system of French social security

Primary outcomes:
measure: Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03
timeFrame: 3 months after end of radio-chemotherapy treatment
Secondary outcomes:
measure: Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03
timeFrame: 3 months after end of radio-chemotherapy treatment
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: Caen
country: France
facility: Centre François Baclesse
city: Dijon
country: France
facility: CLCC Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Nantes
country: France
facility: Centre rené Gauducheau
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Tours
country: France
facility: CHU de Tours
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References: