louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04285294: Molecular Signatures of Cutaneous Squamous Cell Carcinoma During Recessive Dystrophic Epidermolysis Bullosa
Official title: Molecular Signatures of Cutaneous Squamous Cell Carcinoma During Recessive Dystrophic Epidermolysis Bullosa
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recessive Dystrophic Epidermolysis Bullosa
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RDEB patients with a SCC and non-RDEB patients with a SCC induced by ultraviolet radiation

Brief summary: Recessive dystrophic epidermolysis bullosa (RDEB) is a hereditary skin disease characterized by cutaneous and mucosa fragility. Blister formations and erosions, resulting in chronic wounds and dystrophic scars, lead development of aggressive cutaneous squamous cell carcinoma (cSCC) in young subjects. cSCC in RDEB patients are often recurrent and sometimes aggressive. Although fibrotic and inflammatory microenvironment plays an important role in the tumoral process, specific mechanisms in cSCC of RDEB patients are still unknown. Actually, the only treatment is a wide surgical excision with poor prognostic (80% of death after the first occurrence of cSCC).

The objective of the study is to describe the molecular signatures in the cSCC in RDEB patients


Eligibility criteria: Inclusion Criteria:

* for RDEB patients with a SCC :

  1. aged older than 18 years old
  2. one or more SCC surgically treated
  3. signed genetic consent form
* for non-RDEB patients with a SCC induced by ultraviolet radiation :

  1. aged older than 18 years old
  2. one or more SCC induced by ultraviolet radiation
  3. signed genetic consent form

Exclusion Criteria:

* under protection by law (tutorship or curatorship)
* without health insurance coverage

Primary outcomes:
measure: Characterize the molecular signatures in the cSCC and the peri-tumoral dystrophic area occurring in RDEB patients
timeFrame: at inclusion
Secondary outcomes:
measure: Comparison of molecular signature according to the aggressive evolution
timeFrame: at inclusion
measure: Comparison of molecular signatures between cSCC from RDEB patients versus cSCC from non-RDEB patients (induced by ultraviolet radiation)
timeFrame: at inclusion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06755294: Vestibular Incision Subperiosteal Tunnel Access (VISTA) Technique Versus Coronally Advanced Flap (CAF) Combined With a Connective Tissue Graft for the Treatment of Maxillary Gingival Recessions
Official title: Vestibular Incision Subperiosteal Tunnel Access (VISTA) Technique Versus Coronally Advanced Flap (CAF) Combined With a Connective Tissue Graft for the Treatment of Maxillary Gingival Recessions: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingival Recessions
Keywords: VISTA TECHNIQUE
CAF
Root Coverage
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gingival recession (GR) is a common oral health problem that causes sensitivity, esthetic concerns and hygiene problems. Successful root coverage can be achieved by various surgical techniques. The VISTA technique may overcome some of the limitations of other techniques and present equal results to techniques that are considered the "Gold Standard" in this area of periodontology.

The objective of the research is to study the VISTA technique in terms of complete root coverage, % root coverage, gingival thickness gain, bleeding on probing, keratinized gingival width, PROMS, vestibular depth and esthetic results.


Eligibility criteria: Inclusion Criteria:

* Healthy adults: men and women between 18 and 75 years of age.
* Accepts and signs informed consent.
* Systemically healthy patients with periodontal health or controlled periodontitis.
* Presence of at least two maxillary Cairo Type I or II (RT1/2) recessions \> 2 mm deep on buccal aspect.
* Plaque index ≤20%
* No previous periodontal surgeries performed.
* Presence of the cementoenamel junction (CEJ), a 1 mm step in the CEJ and/or presence of root abrasion, but with an identifiable CEJ will be accepted.

Exclusion Criteria:

* Smoker of 10 ≥ cigarettes per day.
* Contraindications to periodontal surgery.
* Medications that affect the gingiva or their healing.
* Active orthodontic treatment.
* Pregnant women
* Caries or restorations in the area to be treated.
* Patients who cannot follow the post-surgical medication adequately

Primary outcomes:
measure: Recession reduction (RR)
timeFrame: 3 months and 6 months after the surgery
Secondary outcomes:
measure: mean root coverage (% RC)
timeFrame: 3 and 6 months after the surgery
measure: PPD
timeFrame: Baseline, 3 and 6 months after the surgery
measure: CAL
timeFrame: Baseline, 3 and 6 months after the surgery
measure: KTW
timeFrame: Baseline, 3 and 6 months after the surgery
measure: Gingival thickness
timeFrame: Baseline, 3 and 6 months after the surgery
measure: Complete root coverage
timeFrame: 3 and 6 months after the surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01881594: Stimulation of Efferent Loop Prior to Ileostomy Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ileostomy; Complications
Keywords: ileostomy closure,postoperative ileus,stimulation ileostomy
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare postoperative ileus between stimulated and unstimulated patients prior to ileostomy closure.

Detailed description: Stimulation was performed ten days prior to the intervention, through the efferent limb of the ileostomy with 500 cc of a thickening substance (saline and nutritional thickener)

Eligibility criteria: Inclusion Criteria:

* protective ileostomy after rectal cancer surgery

Exclusion Criteria:

* under 18 years

Primary outcomes:
measure: postoperative ileus
timeFrame: within the first days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Abrisqueta J, Abellan I, Lujan J, Hernandez Q, Parrilla P. Stimulation of the efferent limb before ileostomy closure: a randomized clinical trial. Dis Colon Rectum. 2014 Dec;57(12):1391-6. doi: 10.1097/DCR.0000000000000237.
Clinical trial NCT03928691: Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level
Official title: Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level in Pregnant Recipients of Magnesium Sulphate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women included will be classified according to BMI underwieght ( less than 18.85) , Normal weight (18.5-24.9)

, Overweight (25-29.9) and obese (30 or more)

Brief summary: Magnesium sulphate is an inorganic salt with multiple therapeutic applications in medicine it has been widely utilized and studied on a diverse set of conditions such as asthma, cardiac arrhythmia and stroke. In pregnant women ,MgSo4 has been used in many cases such as for seizures prophylaxis in preeclampsia, tocolysis in preterm labour and for fetal neuroprotection in immenint preterm delivery.MgSo4 has been used as the standard drug for tocolysis in preterm labour and other drugs have been compared to it.


Eligibility criteria: Inclusion criteria:

pregnant women 34 weeks or less admitted to Women's Health Hospital with a diagnosis of :

* sever preeclampsia. It is defined as 1- blood pressure 160/110 mmHg or more 2- proteinurea (+3 or more by dipstick) 3-HELLP syndrome
* threatened preterm labour that will receive Magnesium Sulphate either for tocolysis or neuroprotection.

Exclusion criteria:

- women with more than 34 weeks gestation and with any contraindication for Magnesium Sulphate intake like severe renal impairment or myasthenia gravis.

Primary outcomes:
measure: the percentage of women reaching the Mg therapeutic level.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT05860491: Dietary Fiber and Hyperkalemia in Dialysis Patients
Official title: The Role of Dietary Fiber on Hyperkalemia in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperkalemia
Hemolysis
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing hemodialysis

Brief summary: To analyze the dietary nutrition and dietary fiber (DF) intake of maintenance hemodialysis (MHD) patients, and explore the effect of dietary nutrition and DF intake balance on the nutritional status and pre-dialysis hyperkalemia of MHD patients.

Detailed description: A total of 100 MHD patients were retrospectively enrolled, including 67 males and 33 females. The daily diet was recorded by 3-day dietary recording method. The daily average dietary nutritional intake and DF intake of MHD patients were calculated by professional software. Dietary guidance and analysis were conducted according to the Expert Consensus on Nutrition in Chronic Kidney Disease (2005) and the Dietary Guidelines for Chinese Residents (2016). Of the 100 patients, 37 had hyperkalemia (serum potassium \> 5.5 mmol/L) before dialysis.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old; undergoing hemodialysis at least 3months; with a certain level of education; with complete behavioral ability

Exclusion Criteria:

* In the acute phase of acute cardiovascular disease, acute cerebrovascular disease, and acute digestive system disease；Anorexia, long-term malnutrition, or dietary disorders；poor compliance；

Primary outcomes:
measure: Dietary fiber intake
timeFrame: 3 day
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Yang Li, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05075291: Suicide Attempts and Tramadol : a Case Report
Official title: Repeated Suicide Attempts in a Patient Suffering From Addiction to Tramadol: a Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide, Attempted
Addiction
Keywords: Suicide
Addiction
Opioids
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A single patient with multiple suicide attempts related to her addiction to Tramadol.

Brief summary: In France, over the last years the use weak opioid analgesics decreased́, whereas that of strong opioid analgesics (OFMA). Hospitalizations for opioid overdose increased́ by 128% from 2000 to 2015, and deaths related to prescribed opioid overdose increased significantly, by 161%, from 2000 to 2014.In addition, recent studies suggest a link between opioid system dysfunction and suicidal behavior.

In parallel, studies are emerging showing the potential interest of using Tramadol as an antidepressant. Indeed, this opiate analgesic also acts on the serotonergic and dopaminergic systems, and would have an antidepressant effect.Thus, the investigators can legitimately wonder whether the use of Tramadol as an antidepressant might not pose a problem in patients at risk of suicide.

This study aims to describe a clinical case of a patient hospitalized in the Department of Psychiatric Emergency and Post-Emergency (Montpellier University Hospital) who developed a severe addiction to Tramadol (consumption up to 5 times the maximum recommended dose per day) and evaluate whether this may have increased her suicidal risk, in order to warn prescribers about the suicidal risk of Tramadol.


Eligibility criteria: Inclusion criteria:

* Multiple suicide attempts
* Tramadol addiction

NA : patient case report

Exclusion criteria:

- None

Primary outcomes:
measure: Lifetime suicidal events
timeFrame: day 1
Secondary outcomes:
measure: Depressive symptomatology
timeFrame: day 1
measure: Suicidal ideation
timeFrame: day 1
measure: Psychological pain
timeFrame: day 1
measure: Anxiety
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Bénédicte NOBILE, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02848391: Hypobaric Flight Simulation in COPD Patients
Official title: Impact of Hypobaric Flight Simulation on Walking Endurance in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Hypoxia
Aviation
Lead sponsor: Krankenhaus Kloster Grafschaft
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Aim of this study was to evaluate the hypoxic response during hypobaric flight simulation in normal individuals as well as in normocapnic and hypercapnic COPD patients as well as to evaluate the impact of a flight simulation on walking endurance in these patients.

Detailed description: Background and aim:

Commercial aircrafts have their altitude compensation adjusted to 2500 meter above sea level which corresponds to a pressure difference of about 270 hPa. This causes a reduction of the partial pressure of oxygen during the flight. Patients with lung disease are especially challenged by large walking distances within airports and during their journey. The objective of our study is to evaluate the impact of a simulated flight under hyperbaric conditions on walking endurance in healthy individuals as well as in COPD Patients with and without hypercapnia.

Method:

Healthy individuals as well as COPD patients were assessed pre-flight with the following measurements:

1. Arterial blood gas analysis
2. Lung function test
3. Lung diffusion test
4. Hemoglobin level
5. Six minute walking distance

During the flight measurements included (measured every 30 minutes until landing):

1. Heartrate
2. Oxygen saturation
3. Borg scale

Post flight measurements included:

1. Arterial blood gas analysis
2. Six minute walking distance

Intended analysis:

* Description of endurance response as a function of COPD disease severity.
* Description of endurance response in normocapnic and hypercapnic COPD patients.
* Detection of pre-flight predictors that determine flight tolerability and hypoxic response.

Eligibility criteria: Inclusion Criteria:

* No lung disease
* COPD without hypercapnea
* COPD with hypercapnea

Exclusion Criteria:

* Claustrophobia
* Renal insufficiency
* Heart failure (ejection fraction \< 45 %)

Primary outcomes:
measure: Change in six minute walking distance measured in meters
timeFrame: 30 Minutes before and after a 3 hour simulated flight (Time point - 30 and + 210 minutes)
Secondary outcomes:
measure: minimal Oxygen saturation measured by pulse oxymetry in %
timeFrame: measurement completed at 180 minutes
Other outcomes:
Locations:
city: Schmallenberg
country: Germany
facility: Kloster Grafschaft
state: NRW
Study officials:
References:
Clinical trial NCT03815591: Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents
Official title: Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking
Keywords: smoking
tobacco
e-cigarettes
flavored tobacco
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 560
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To examine the effects on participants who play the smokeSCREEN game in that the game will have positive changes in their attitudes, beliefs, knowledge, intentions, behaviors and other outcomes related to smoking and tobacco products.

Detailed description: For this project, the CVS Pharmacy Health Foundation has identified after-school, school, and youth programs nationwide with whom to partner. For this project, the play2PREVENT Lab will provide these programs access to the tobacco use reduction/prevention game that the lab has created (smokeSCREEN). Program and school staff will enroll participants between the ages of 10-16 to play smokeSCREEN during their after school, school, and youth program. Before and after gameplay, participants will answer assessment questions related to their attitudes, beliefs, knowledge, intentions, and behaviors around smoking and tobacco product use. The data will be transmitted electronically via the LimeSurvey data collection platform to the Lab, for further analysis. None of the Lab staff will have contact with participants or after-school/school/youth program coordinators or staff.

Eligibility criteria: Inclusion Criteria:

* Anyone with a userID and password.

Exclusion Criteria:

* Does not fit the inclusion criteria

Primary outcomes:
measure: Changes in beliefs
timeFrame: baseline
measure: Changes in beliefs
timeFrame: immediately after game play is completed
measure: Change in knowledge
timeFrame: Baseline
measure: Change in knowledge
timeFrame: immediately after game play is completed
measure: Change in intentions
timeFrame: Baseline
measure: Change in behaviors
timeFrame: Immediately after gameplay is completed
measure: Changes in social norms
timeFrame: Baseline
measure: Changes in social norms
timeFrame: Immediately after gameplay is completed
Secondary outcomes:
measure: Gameplay satisfaction: post-test survey
timeFrame: immediately after game play is completed
Other outcomes:
Locations:
city: New Haven
country: United States
facility: play2PREVENT Lab at the Yale Center for Health & Learning Games
state: Connecticut
Study officials:
affiliation: Yale University
name: Lynn Fiellin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04401891: Formal Pre-Operative Education
Official title: The Benefit of Formal Pre-operative Education to Patient Satisfaction, Pain and Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Upper Extremity Orthopedic Surgery Patients
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators want to determine if delivering formal preoperative education to patients helps the patients with post operative pain, function and overall satisfaction. Education would cover surgery, post operative activities of daily living, pain and edema management, duration of recovery and any expected therapy they might need. All participants will receive a pre and post operative questionnaire to determine level of understanding of anticipated needs and barriers due to surgery. Group one will receive formal education from an occupational therapist or physical therapist while Group two will receive only standard education in the MD clinic.


Eligibility criteria: Inclusion Criteria:

* 18 years or older,
* English as Primary language,
* scheduled to have orthopedic upper extremity surgery.

Exclusion Criteria:

* less than 18 years
* Conservative management or non operative management of orthopedic upper extremity surgery

Primary outcomes:
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function Subtest -- change is being assessed
timeFrame: prior to surgery and two weeks post surgery
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety subtest -- change is being assessed
timeFrame: prior to surgery and two weeks post surgery
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Depression subtest -- change is being assessed
timeFrame: prior to surgery and two weeks post surgery
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference subtest -- change is being assessed
timeFrame: prior to surgery and two weeks post surgery
measure: PROMIS (Patient-Reported Outcomes Measurement Information System)Upper Extremity Function subtest -- change is being assessed
timeFrame: prior to surgery and two weeks post surgery
measure: MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) Pre-Operative
timeFrame: prior to surgery
measure: MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) post operative
timeFrame: 2 weeks post surgery
measure: Pain Scale
timeFrame: prior to surgery and 2 weeks post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in Saint Louis
state: Missouri
Study officials:
affiliation: Washington University in Saint Louis
name: Logan Berlet, OTD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00984191: Pilot 99mTechnetium-MIBI Single Photon Emission Computed Tomography - Computed Tomography (SPECT-CT) in Papillary Carcinoma (CA) Thyroid
Official title: 99mTechnetium-MIBI SPECT-CT for Pre-operative Evaluation of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma; A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Papillary Thyroid Cancer
Keywords: Papillary thyroid cancer
99mTechnetium MIBI SPECT CT
preoperative
cervical lymphadenopathy
cervical metastasis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this trial is to see if the 99mTechnetium-MIBI SPECT-CT can be a tool for preoperative evaluation of cervical node metastasis in papillary thyroid cancer.


Eligibility criteria: Inclusion Criteria:

* papillary thyroid cancer

Exclusion Criteria:

* pregnancy
* Bleeding abnormality
* Prior history of head and neck cancer
* can not perform 99mTechnetium-MIBI SPECT-CT
* can not perform 131I remnant Ablation
* Prior any head and neck surgery within 3 months
* Prior deep neck infection within 3 months

Primary outcomes:
measure: Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy )
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
facility: King Chulalongkorn Hospital
state: Bangkok
Study officials:
affiliation: Department of Otolaryngology , Faculty of Medicine , Chulalongkorn University
name: Napadon Tangjaturonrasme, Otolaryngologist
role: PRINCIPAL_INVESTIGATOR
References: