louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00951730: Evaluation of a Simplified Method for Diagnosis of Sleep Apnea in Children and Adults With Down Syndrome
Official title: Evaluation of a Simplified Method for Diagnosis of Sleep Apnea in Children and Adults With Down Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Keywords: Down Syndrome
Adult
Children
Sleep apnea
Sleep hypopnea
Polysomnography
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2009-08-04
Enrollment: 97
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Down syndrome

Brief summary: People with Down syndrome are at increased risk of sleep apnea, not only from obstruction of the upper airway, but also of central origin. According to published data, sleep apnea may occur in at least 40% of children and adults with Down syndrome. Consequences of these sleep apnea are numerous : failure to thrive, cognitive decline, high blood pressure, heart disease, accident due to day sleepiness, fatigue. This condition is treatable in people with Down syndrome, as it is in ordinary people.

Diagnosis of sleep apnea in people with Down syndrome is therefore a major concern. In addition, data regarding age of apparition of this complication are missing, making repeated screening necessary.

Polysomnography is the method of choice for the diagnosis of sleep apnea. Unfortunately, it is time consuming and sleep departments are heavily busy.

Detailed description: The main objective of our study is to evaluate an easier screening strategy combining questionnaire and overnight recording of few data, compared to polysomnography.

We hope our strategy will permit regular screening for people with Down syndrome, helping us to draw guidelines for the survey of sleep apnea in this population.

Eligibility criteria: Inclusion Criteria:

* Down syndrome
* Patient (or parents of children) affiliated in a Social Regimen
* Written consent signed (by parents for the children)

Exclusion Criteria:

* Severe heart failure
* Insufficient autonomy
* Diagnosis of insanity, or behavioural problems

Primary outcomes:
measure: Apnea / hypopnea events index determined by reading the complete polysomnography (review reference) and apnea / hypopnoea events index determined by the simplified five parameters of the polysomnography
timeFrame: At 15 days after enroling
Secondary outcomes:
measure: Questionnaire on sleep
timeFrame: At inclusion and at the end (18 months)
measure: Psychometric tests
timeFrame: At inclusion and at the end (18 months)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: Hospices Civiles de lyon
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Benedicte De Freminville, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02064530: Postoperative Analgesic Effects of Dexmedetomidine for Transversus Abdominis Plane Block
Official title: Postoperative Analgesic Effects of Dexmedetomidine Added to Bupivacaine for Transversus Abdominis Plane Block for Lower Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: TAP block
dexmedetomidine
bupivacaine
postoperative analgesia
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 evaluate postoperative analgesic effects of dexmedetomidine added to bupivacaine on TAP block in patients undergoing lower abdominal surgery.

Detailed description: TAP block is being used a method of multimodal balanced analgesia reduces postoperative pain, opioid requirement after surgery and adverse effect of opioid such as sedation, nausea vomiting and ileus. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.

Eligibility criteria: Inclusion Criteria:

* ASA 1-2
* 18-65 aged
* patient undergoing lower abdominal surgery

Exclusion Criteria:

* chronic opioid consumption
* bupivacaine and dexmedetomidine allergies
* coagulopathy
* infection at the needle insertion side
* chronic liver and kidney disease

Primary outcomes:
measure: opioid consumption
timeFrame: postoperative 1 day
Secondary outcomes:
measure: visual analog scale
timeFrame: postoperative 1 day
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes universty
state: Melikgazi
Study officials:
affiliation: Erciyes universty medicine faculty
name: Recep Aksu, assoc. prof.
role: STUDY_DIRECTOR
affiliation: Erciyes universty medicine faculty
name: Gülçin Patmano, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05756530: The Experience of Affective Touch in Anorexia Nervosa
Official title: The Experience of Affective Touch in Obesity: the Role of Social Anhedonia and Lifespan Experiences
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anorexia Nervosa
Keywords: affective touch
social anhedonia
lifespan bodily contacts
Interpersonal relationships
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with AN were consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).

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Brief summary: The aim of the present research will be to verify if the pleasantness of affective touch is comparable between women with AN and healthy women while measuring the level of social anhedonia and the lifespan experience of affective touch.


Eligibility criteria: Inclusion criteria:

* Right-handed
* diagnosis of restricting type or binge-eating/purging type AN, according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition)'s criteria (DSM, American Psychiatric Association, 2013).

Exclusion Criteria:

* Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders
* Evidence of any skin-related condition possibly affecting sensitivity on the participants' forearm (e.g., eczema, scars).

Primary outcomes:
measure: Rating of subjective pleasantness
timeFrame: Baseline
Secondary outcomes:
measure: Social Anhedonia Score
timeFrame: Baseline
measure: Affective experience Score
timeFrame: Baseline
Other outcomes:
Locations:
city: Piancavallo
country: Italy
facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
state: VCO
Study officials:
affiliation: IRCCS Istituto Auxologico Italiano
name: Federica Scarpina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06331130: Mesenteric Infiltration in Ovarian Cancer
Official title: CT Detected Tumour Infiltration Patterns of the Mesentery in High Grade Ovarian Carcinoma (HGSOC) Patients, Their Role in Treatment Planning and Outcome Prediction and How Machine Learning Can be Applied to Identify Them.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovary Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Danube University Krems
name: Institut du Cancer de Montpellier - Val d'Aurelle
name: Ente Ospedaliero Cantonale, Ticino, Switzerland
First posted: 2024-03-26
Enrollment: 510
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with confirmed HGSOC who exhibited mesenteric disease, including mesenteric retraction or diffuse mesenteric carcinomatosis, during diagnostic laparoscopy (or without mesenteric disease for the control cohort)

Brief summary: To evaluate if CT features at diagnosis in patients with HGSOC can be used to build an Artificial Intelligence model capable of discerning the pathological involvement of the mesentery, assessing the potential impediments for an optimal debulking surgery and predicting the development of resistance to platinum based chemotherapeutic agents.


Eligibility criteria: Inclusion Criteria:

1. Women with confirmed HGSOC wiht mesenteric involvment
2. Age \> 18 years
3. FIGO STAGE IIIB-IV
4. Primary diagnosis
5. Signed informed consent

Exclusion Criteria:

1. Non-serous high grade epithelial ovarian cancer (serous low grade, mucinous, clear cell carcinoma, endometrioid or non-epithelial ovarian cancer)
2. Early stage disease (I and II stage)
3. CT scan not available
4. Non-primary diagnosis or patient subjected to neoadjuvant chemotherapy

Primary outcomes:
measure: Preoperative Artificial Intelligence assisted CT-based evaluation
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of the Radiologist Assessment of the CT
timeFrame: 1 year
measure: Prediction of Platinum Resistance
timeFrame: 1 year
measure: Prediction of Progression Free Survival (PFS) and Overall Survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Advanced Radiology Center
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Camilla Panico, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402830: Case-control Study- Cancer Pain: Uncontrolled Pain as Depression Development Predictor in Oncologic Patients (Fentanyl)
Official title: DPRESS Study. Case-control Study in Cancer Pain: Uncontrolled Pain as Depression Development Predictor in Oncologic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Pain
Keywords: cancer
depression
pain
Lead sponsor: Janssen-Cilag, S.A.
Sponsor class: INDUSTRY
First posted: 2011-07-26
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with cancer pain who experience depression and pain after cancer diagnosis

Brief summary: The purpose of this study is to evaluate the relationship between cancer pain and risk of depression among cancer patients.

Detailed description: This is a retrospective observational and case-control multicenter study. The main objective of this study is determine the degree of association between cancer pain and depression by impact assessment of adequate control of pain associated with cancer risk depression in patients attending the Oncology Unit. The assessment of pain intensity will be performed by using visual analogue scales (EVAs) and verbal descriptive scales, as an observational study, not limit or modify the use of any drug. The patients included in this study have a medical history of cancer pain and mild depression (Beck = 8). The controls are patients with history of cancer pain and mild or absent depression (Beck = 7). n/a

Eligibility criteria: Inclusion Criteria:

* Patients =18 years old
* have medical data of = 3 months
* experience pain after cancer diagnosis and complete the Beck Depression Inventory (BDI)
* patients who give informed written consent
* patients with no mental or physical disorders that unable them to complete the BDI.

Exclusion Criteria:

* Patients with diagnosis of depression before cancer diagnosis
* patients with chronic pain prior to the diagnosis of cancer, and cancer disease has not changed its course
* patients with other previous mental disorders
* patients who do not give their informed written consent.

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: 3 months
measure: Visual scales analog (EVAs)
timeFrame: 3 months
Secondary outcomes:
measure: Number of patients with cancer pain.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag, S.A.
name: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT05747430: SteRilizing Eye SoLution to ImprovE Patient ComFort (RELIEF)
Official title: Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Injection Pain and Corneal Epitheliopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Retinal Disease
Lead sponsor: iRenix Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to IRX-101 or Providone-Iodine
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections. The study will be conducted in up to 15 centers in the United States (US).


Eligibility criteria: Inclusion Criteria:

1. Capable of giving informed consent
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes

Exclusion Criteria:

1. Current or past diagnosis of endophthalmitis
2. Current diagnosis of uveitis
3. Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
4. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
5. Currently receiving intravitreal steroid injections
6. Concurrent participation in another clinical trial
7. Females who are pregnant, planning to become pregnant or lactating

Primary outcomes:
measure: Safety of new drug
timeFrame: 1-hour and 1-week post-treatment
Secondary outcomes:
measure: Mean corneal fluorescein staining scores
timeFrame: Immediately following intraviteral injection
measure: Patient-reported post-injection pain scores
timeFrame: 1-hour post-administration
Other outcomes:
Locations:
city: Round Rock
country: United States
facility: Edward Wood, MD
state: Texas
Study officials:
affiliation: Founder
name: Stephen Smith, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01354730: A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Reactions
Keywords: incidence
nature
seriousness
ADRs
vaccination
Lead sponsor: Adimmune Corporation
Sponsor class: INDUSTRY
First posted: 2011-05-17
Enrollment: 398
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population was derived from medical centers in Taiwan: National Taiwan University Hospital, Chang Gung Memorial Hospital - LinKou and China Medical University Hospital.

The sample size for this study was planned to include 500 cases in exposed cohort and 500 cases in unexposed cohort. Actual recruitment depended on the volume of pregnancy women received AdimFlu-S (A/H1N1) at each hospital. The size of unexposed cohort was be equal to the exposed cohort.

Brief summary: This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review. If subject meets the eligibility criteria during the study period, data from the medical chart were extracted retrospectively from the date of vaccination and the infant (s) health status were followed until 8 weeks after the delivery.The unexposed cohort included pregnant women who did not receive any influenza vaccine during pregnancy. Within each participated study center, women who were gestation after April 2009 were randomly selected according to maternal age matching. The pregnancy outcome, including the status of delivery, abortion and gestational age, were extracted retrospectively by chart review.


Eligibility criteria: Inclusion Criteria:

Exposed Cohort:

* The woman received AdimFlu-S (A/H1N1) vaccination between 2009/10 and 2010/02.l
* The woman was pregnant at the time of vaccination.

Unexposed Cohort:

* The woman was gestation after April 2009.

Exclusion Criteria:

Exposed Cohort:

* Received any other H1N1 vaccination, e.g., Focetria.

Unexposed Cohort:

* The woman received any influenza vaccine during gestation period.

Primary outcomes:
measure: The purpose of this study was to evaluate the incidence, nature and seriousness of adverse drug reactions (ADRs) occurring after vaccination.
timeFrame: 8 weeks after the delivery or abortion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01180530: Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction in Children and Adolescents With Type 1 Diabetes
Official title: A Multicentre, Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction of Insulin Therapy in Children and Adolescents With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-08-12
Enrollment: 358
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any child or adolescent with type 1 diabetes who has just started using NovoPen Echo® is eligible. The selection of the patients will be at discretion of the individual physician.

Brief summary: This study is conducted in Asia, Europe and North America. The aim of this observational study is to evaluate the safety of NovoPen Echo® by collecting safety information (incidence of technical complaints related to adverse reactions). Study duration: 12-18 weeks.


Eligibility criteria: Inclusion Criteria:

* Children/adolescents with type 1 diabetes mellitus
* After the participating physician's decision has been made to initiate treatment with NovoPen Echo®, any patient who meets all the inclusion criteria and does not meet any of the exclusion criteria, is eligible to participate
* Use of insulin pen or syringes for at least 12 months

Exclusion Criteria:

* Insulin pump or Insuflon® users
* Any disease or condition in children/adolescents which might interfere with the study at the individual physician's discretion

Primary outcomes:
measure: The incidence of technical complaints related to adverse reactions
timeFrame: after 12-18 weeks (end of study)
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Novo Nordisk Investigational Site
city: Espoo
country: Finland
facility: Novo Nordisk Investigational Site
city: Kfar Saba
country: Israel
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Hansen B, Lilleore SK, Ter-Borch G. Needle with a novel attachment versus conventional screw-thread needles: a preference and usability test among adults with diabetes and impaired manual dexterity. Diabetes Technol Ther. 2011 May;13(5):579-85. doi: 10.1089/dia.2010.0214. Epub 2011 Mar 15.
citation: Adolfsson P, Veijola R, Huot C, Hansen HD, Lademann JB, Phillip M. Safety and patient perception of an insulin pen with simple memory function for children and adolescents with type 1 diabetes--the REMIND study. Curr Med Res Opin. 2012 Sep;28(9):1455-63. doi: 10.1185/03007995.2012.698258. Epub 2012 Jul 27.
Clinical trial NCT02243930: Cap-assisted Sigmoidoscopy - Influence on Pain, Duration and Rate of Success
Official title: Cap-assisted Sigmoidoscopy - Reduction in Pain, Reduction in Investigation Time and Increased Rate of Success, When Examined by the Less-experienced Endoscopist. A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Sigmoidoscopy with or without cap
Pain during sigmoidoscopy
Sigmoidoscopy and time
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the attachment of a transparent hood ("cap") on the sigmoidoscope. The investigators hypothesis is that this will reduce pain, reduce investigation time, and increases the success rate of the sigmoidoscopy. The study focus on the less-experienced endoscopist.

Detailed description: The investigators randomize study subject to sigmoidoscopy +/- the attachment of the cap.

Using a 100mm VAS scale the investigators record pain when the sigmoidoscopy reaches its intubation end-point (60cm from anus). The investigators also register the time spent to this point and the rate of examinations not achieving this endpoint.

Eligibility criteria: Inclusion Criteria:

* planned to undergo sigmoidoscopy
* informed consent

Exclusion Criteria:

* use of iv medication for pain and/or anxiety immediately before the endoscopy
* lack of indication for a full sigmoidoscopy (eg just need to investigate the rectum)
* lack or improper administration of standard bowel preparation

Primary outcomes:
measure: VAS recording of pain
timeFrame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
Secondary outcomes:
measure: Time
timeFrame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
Other outcomes:
measure: rate of success
timeFrame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
Locations:
city: Koege
country: Denmark
facility: Surgical department, endoscopy unit, Koege Hospital, Denmark
state: Region Sjaelland
Study officials:
affiliation: Koege Hospital, Surgical Department
name: Magnus Ploug, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ploug M, Poulsen JK, Jensen HQ, Achiam M. The use of a transparent cap in sigmoidoscopy-A randomized controlled clinical trial on pain, time and success rate. Indian J Gastroenterol. 2017 Jul;36(4):318-322. doi: 10.1007/s12664-017-0776-y. Epub 2017 Aug 1.