louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06180785: Performance Evaluation of the Biological Diagnosis of HIT
Official title: Performance Evaluation of the Biological Diagnosis of Heparin-induced Thrombocytopenia (HIT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heparin-induced Thrombocytopenia (HIT)
Keywords: Heparin-induced thrombocytopenia
HIT
heparin therapy
heparin treatments
molecular weight heparin
IgG antibodies
platelet factor 4 (PF4)
heparin complex
thrombotic risk
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 894
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: Adult patient (≥ 18 years of age) hospitalized at HUS between 01/01/2009 and 31/12/2019

Brief summary: Heparin-induced thrombocytopenia (HIT) is a severe complication of heparin therapy with a non-negligible incidence (estimated at 2.6% of unfractionated heparin treatments and 0.2% of low molecular weight heparin treatments). It is generally secondary to the appearance of IgG antibodies directed against the platelet factor 4 (PF4) - heparin complex. These antibodies, once bound to this complex, are likely to activate platelets: the thrombotic risk generated can be potentially fatal.


Eligibility criteria: Inclusion criteria :

* Adult patient (≥ 18 years of age)
* Hospitalized at HUS between 01/01/2009 and 31/12/2019
* Specimen sent to the HUS Hematology Laboratory for biological diagnosis of HIT between 01/01/2009 and 31/12/2019
* Data collected by the CRPV and analyzed by the HIT multidisciplinary group in order to reach a consensus decision on the presence or absence of HIT
* Patient does not object to the reuse of his medical data for scientific research purposes.

Exclusion criteria:

* Patient for whom no test has been performed at the HUS Hematology Laboratory
* Patient for whom no data has been collected by the CRPV
* Patient for whom the HIT group could not confirm or deny the presence of HIT

Primary outcomes:
measure: Retrospective description of the biological diagnosis approach for heparin-induced thrombocytopenia (HIT) in the Hematology laboratory of the University Hospitals of Strasbourg
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Laboratoire d'Hématologie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT03133585: Study on the Stoma Appliance Flexima®/Softima® 3S
Official title: Non-Interventional, International, Post-Marketing Clinical Follow-up Study on the Stoma Appliance Flexima®/Softima® 3S
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ostomy
Lead sponsor: BBraun Medical SAS
Sponsor class: INDUSTRY
Collaborators: name: VERTICAL
name: EVAMED
First posted: 2017-04-28
Enrollment: 1500
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: Patient with a Enterostomy or an urostomy

Brief summary: To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up.

The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.

Detailed description: The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years old
* Patient who has had a colostomy or an ileostomy or a jejunostomy or an urostomy for at least 1 month
* Patient agreeing to participate to the study and having signed the informed consent form/information letter in accordance with local requirements
* Patient for whom the use of Flexima®/Softima® 3S has already been decided within the regular planning of his treatment

Exclusion Criteria:

* Patient with cognitive problems, according to the investigator, preventing him from answering a questionnaire or for whom the evaluation could be a problem
* Patient taking part in another clinical evaluation
* Patient having more than one stomy
* Patient vulnerable and under legal protection
* Patient having had an known allergy to one of the components of the appliance
* Patient previously using Flexima®/Softima® 3S

Primary outcomes:
measure: evaluation of the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up
timeFrame: the questions will be asked to the patient at each follow up visits (= at 1 month, 3 months and 6 months).Total Score will range from 3 to 12. A total score of 9 or more will define appropriate overall satisfaction.
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Tenon
state: Ile De France
city: Montpellier
country: France
facility: CHU Lapeyronie
Study officials:
affiliation: Hopital Tenon, Paris, France
name: Danièle Chaumier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06817785: Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere
Official title: Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
Collaborators: name: Centre for Ocular Research & Education, Canada
First posted: 2025-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate and compare the performance of two soft contact lenses.

Detailed description: The aim of this study is to evaluate and compare the performance of a hydrogel lens and a silicone hydrogel lens in existing myopic soft lens wearers.

Eligibility criteria: Inclusion Criteria:

1. Are at least 18 years of age and have full legal capacity to volunteer;
2. Have understood and signed an information consent letter;
3. Are willing and able to maintain the appointment schedule;
4. Are an adapted soft contact lens wearer;
5. Have a vertex-corrected contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
6. Have a refraction with a cylinder component of no more than -1.00DC in each eye;
7. Can be fitted with and achieve a distance visual acuity of +0.10 logMAR or better in each eye with the study contact lenses.

Exclusion Criteria:

1. Are participating in any concurrent clinical or research study;
2. Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use;
3. Have a systemic condition that would contraindicate contact lens use;
4. Are using any systemic or topical medications that would contraindicate contact lens use;
5. Have known sensitivity to the diagnostic fluorescein sodium to be used in the study;
6. Are an employee of the Centre for Ocular Research \& Education directly involved in the study (i.e. on the delegation log).

Primary outcomes:
measure: Lens Comfort
timeFrame: Immediately after lens application
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: School of Optometry and Vision Science
state: Ontario
Study officials:
affiliation: Centre for Ocular Research and Education
name: Lyndon Jones, PhD FCOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02327585: Behavioral Intervention for Children With Attention Deficit Hyperactivity Disorder(ADHD)
Official title: Study on the Psychological Behavior Intervention Technology of Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Executive function training
child
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ADHD children have executive function (EF) impairments,so we randomize the children to the training or a waitlist to improve EF ,adding contingent reinforcement to ascertain whether EF deficits are amenable to the training in children with ADHD.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of child ADHD
* full-scale intelligence quotient (FSIQ) ≥70
* stable on medication for ADHD children at least 3 months

Exclusion Criteria:

* individuals with major neurological disorders
* a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders

Primary outcomes:
measure: change in ADHD-rating scale
timeFrame: baseline,after the training (12week)
Secondary outcomes:
measure: change in behavior rating scale of executive function
timeFrame: baseline,after the training (12week)
measure: cambridge Neuropsychological Test Automatic Battery
timeFrame: baseline,after the training (12week)
measure: Conners
timeFrame: baseline,after the training (12week)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital/Institute of Mental Health
Study officials:
affiliation: Peking University
name: li yang, PHD MD
role: STUDY_DIRECTOR
References:
citation: Qian Y, Chen M, Shuai L, Cao QJ, Yang L, Wang YF. Effect of an Ecological Executive Skill Training Program for School-aged Children with Attention Deficit Hyperactivity Disorder: A Randomized Controlled Clinical Trial. Chin Med J (Engl). 2017 Jul 5;130(13):1513-1520. doi: 10.4103/0366-6999.208236.
Clinical trial NCT02009085: Pilot Study to Determine Feasibility of Benign and Malignant Skin Lesion Detection.
Official title: Pilot Study to Asses the Identification of Melanoma in Skin Lesions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Lesions
Lead sponsor: Orlucent, Inc
Sponsor class: INDUSTRY
Collaborators: name: Clalit Health Services
First posted: 2013-12-11
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients above 18 years scheduled for a skin biopsy.

Brief summary: In this study a fluorescent contrast dye is applied to a suspicious skin lesion.

Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation in the skin.

Detailed description: Images acquired in the study are used for the development of a software analysis program.

Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Individual is scheduled for a skin biopsy in toto
* The lesion is pigmented or non pigmented
* Lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis.
* The lesion is accessible to the imaging device

Exclusion Criteria:

* The patient has sensitive skin and easily breaks out in rash
* The lesion is within 1 cm of the eye
* The lesion is on mucosal surfaces (e.g., lips, genitals)
* Pregnant females
* Taking medications that pigments the skin

Primary outcomes:
measure: Correlation between imaging and pathology.
timeFrame: No long term follow up is necessary.
Secondary outcomes:
measure: Acute response
timeFrame: up to 1 day
Other outcomes:
measure: None specified.
timeFrame: 0
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Yehuda Ullmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01453985: Full-Thickness-Gastroplication For The Treatment Of Gastroesophageal Reflux Disease GERD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: General Public Hospital Zell am See
Sponsor class: OTHER
First posted: 2011-10-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.


Eligibility criteria: Inclusion Criteria:

* persistent or recurrent symptoms despite continuous medical treatment, at least one typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste), pathologic esophageal acid exposure as documented by a reflux-related DeMeester score ≥14.7, and symptom correlation ≥50%, and/or reflux episodes \>73.

Exclusion Criteria:

* any distinct hiatal hernia detectable by gastroscopy or barium radiography, dysphagia, esophageal strictures, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.

Primary outcomes:
measure: Quality of Life
Secondary outcomes:
Other outcomes:
Locations:
city: Zell am See
country: Austria
facility: General public hospital Zell am See
Study officials:
References:
citation: Koch OO, Kaindlstorfer A, Antoniou SA, Spaun G, Pointner R, Swanstrom LL. Subjective and objective data on esophageal manometry and impedance pH monitoring 1 year after endoscopic full-thickness plication for the treatment of GERD by using multiple plication implants. Gastrointest Endosc. 2013 Jan;77(1):7-14. doi: 10.1016/j.gie.2012.07.033. Epub 2012 Sep 26.
Clinical trial NCT05959785: Diaphragmatic Exercises As Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Clinical Trial.
Official title: Diaphragmatic Exercises As Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Keywords: pain
phrenic nerve
shoulder
laparoscopy
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial with control group and random assignment intervention
Primary purpose: TREATMENT

Brief summary: Through a blinded clinical trial, the aim is to evaluate the efficacy of manual therapy in the treatment of pain referred to after laparoscopic hysterectomy.

Control and intervention groups were randomly established. Informed consent will be requested for participation in the study.


Eligibility criteria: Inclusion Criteria:

* • Patients who have given their consent to participate in the project by signing the informed consent.

  * Patient between 18 and 65 years of age.
  * Patients with a hysterectomy scheduled to be performed in less than 3 months at the Women's Hospital in Seville or at the Quirón Sagrado Corazón Clinic in Seville.
  * Who develops pain of intensity greater than 7 points located in the head, neck or upper limbs in the first 24 hours post-hysterectomy.
  * Patients who are able to communicate in Spanish or English.

Exclusion Criteria:

* Neurological Pathology.
* Non-cooperative Subject.
* Severe Psychiatric Illness.
* Loss of Cognitive Capacity.
* Evidence that post-hysterectomy pain is not caused by surgery (eg, presence of fracture or infection in the head, neck or upper limbs.
* Localized pain in areas not considered in this study and that may affect the performance and results of the study.

Primary outcomes:
measure: The McGill Pain Questionnaire
timeFrame: 24 hours after laparoscopy
measure: The Brief Pain Questionnaire
timeFrame: 24 hours after laparoscopy
measure: The Quick Dash quiz
timeFrame: 24 hours after laparoscopy
measure: The HIT-6 scale
timeFrame: 24 hours after laparoscopy
measure: The Neck Disability Index questionnaire
timeFrame: 24 hours after laparoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Quiron Sagrado Corazon
Study officials:
References:
Clinical trial NCT02677285: Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing
Official title: Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skin Graft
Closed Operation Wound
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University of Technology
name: Åbo Akademi University
name: Turku PET Centre
name: Tampere University
First posted: 2016-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in Plastic surgery and KEI2 wards at Tampere University Hospital

Brief summary: This study consists of two clinical series. With the first series investigators monitor the healing of skin grafts with bioimpedance measurements. The bioimpedance measurement is done with a purpose built patch that has electrodes in contact with the wound and reference electrodes.

In the second series the investigators monitor closed operational wounds (breast reconstruction surgery patients) with bioimpedance measurements. This series is also conducted with bioimpedance measurements but the wounds are operational wounds.

Both groups will have 20 patients.

Detailed description: Objectives of the study:

1. The investigators will study how bioimpedance measurement results correlate with conventional wound healing monitoring.
2. The investigators will seek the best methods for handling, interpreting and presenting bioimpedance measurement results.
3. The investigators will find out if impedance measurement is applicable to clinical use.

Eligibility criteria: Inclusion Criteria:

* patients that have a skin graft operation made as part of their treatment
* patients that have breast reconstruction surgery made as part of their treatment

Exclusion Criteria:

* pregnancy
* patients with limited capacity to understand the information regarding the study
* patients with chronic skin disease on operation area

Primary outcomes:
measure: Bioimpedance data
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Ilkka Kaartinen
role: STUDY_DIRECTOR
References:
Clinical trial NCT06088485: The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
Official title: Erişkin Kistik Fibrozisli Bireylerde Kemik Mineral Yoğunluğunun Postür, Solunum Fonksiyonları ve Fonksiyonel Egzersiz Kapasitesi Üzerine Etkisi
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis
Postural Defect
Pulmonary Disease
Physical Inactivity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred by the department of chest diseases of Hacettepe University will be taken

Brief summary: The study was conducted in the age range of 18-45 December, who were diagnosed with Cystic fibrosis.

Detailed description: 60 voluntary patients who have signed the consent form will be included. Within the scope of the research the demographic information of the individuals will be recorded. Functional capacities of individuals With the Shuttle Walking Test at Increasing Speed, respiratory functions respiratory function test, with measurements of respiratory November muscle strength and endurance, the level of dyspnea was Modified Medical Peripheral November muscle strength hand dynamometers with Research Council (mMRC) Dyspnea Scale posture assessment with the Corbin Posture Analysis Scale, trunk mobility with the Trunk Pelvis-Hip Angle Test, core stabilization with Sahrmann's Core Stability Test, individuals' perception of cosmetic deformity Walter Reed visual assessment questionnaires

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18-45 who were diagnosed with Cystic Fibrosis

Exclusion Criteria:

In the last year, patients;

* who had a fracture in any part of the patient's body
* who had undergone spine surgery
* who had an orthopedic, neurological or metastatic history in addition to Cystic Fibrosis

Primary outcomes:
measure: Functional Exercise Capacity
timeFrame: 1 day
Secondary outcomes:
measure: Posture
timeFrame: 1 day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Health Sciences Faculty
Study officials:
affiliation: Hacettepe University
name: Aynur Demirel
role: PRINCIPAL_INVESTIGATOR
References: