louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03093727: Characterization of Pulmonary Langerhans Cell Histiocytosis
Official title: Functional and Genetical Characterization of Pulmonary Langerhans Cell Histiocytosis: Diagnostic and Therapeutical Implications.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Langerhans Cell Histiocytoses
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 20
Sex: ALL
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 diagnosed with Langerhans cell histiocytosis

Brief summary: Very recent studies indicate that a high percentage of HCL, about 50%, have mutations in the B-RAF oncogene. The development of ultrasensitive methodologies capable of identifying these mutations in bronchoalveolar lavage will represent a significant advance in the diagnosis and treatment of these patients. An undetermined percentage of HCL does not present mutations in B-RAF. Consequently, the deep genetic analysis, through the use of techniques of massive sequencing, can favor the identification of new alterations that contribute to the development of the disease.

We hypothesized that patients with HCL may present a different inflammatory state to healthy subjects or smokers, allowing us to identify new biomarkers.

Detailed description: The main objective of this study is to expand the genetic and pathophysiological knowledge of this disease. For this, the following points will be developed:

* Identification of mutations in the B-RAF oncogene in Spanish patients with pulmonary LCHF.
* Development of ultrasensitive genetic analysis methods capable of identifying mutations in B-RAF in bronchoalveolar lavage (BAL) samples.
* To determine if patients with mutations in the B-RAF oncogene present distinct clinical, radiological and / or functional characteristics compared to those with absence of the mutation.
* Characterization of the inflammatory profile of patients with HPCL.

Eligibility criteria: Inclusion criteria

* Men and women with no age limitation
* Established histiological diagnosis of histiocytosis of langerhans cells.
* HCLP-compatible clinical-radiological picture.
* Signed informed consent

Exclusion criteria

* Non-acceptance of informed consent.
* Absence in clinical history of clinical, radiological and functional variables essential for the diagnosis of HLCP.
* Psychiatric disorder or limitation for study compression (including language, socio-cultural problem, etc.).
* Radiological findings suggestive of another chronic lung disease.
* Active respiratory infection.

Primary outcomes:
measure: Number of participants with mutations in the B-RAF oncogene in Langerhans histiocytosis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT01857427: A Prospective Observational Cohort to Study the Genetics of Obstructive Sleep Apnea and Associated Co-Morbidities
Official title: A Prospective Observational Cohort to Study the Genetics of Obstructive Sleep Apnea and Associated Co-Morbidities
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obstructive Sleep Apnea
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects 18 years of age and older who are scheduled for polysomnography (PSG), regardless of final diagnosis AND adult subjects who have already been diagnosed with OSA based on a prior PSG and are already on treatment. OSA diagnosis will be defined as an apnea/hypopnea index (AHI) \>or =5 episodes per hour.

Brief summary: The primary objective of this study is to build a well characterized cohort of patients that will be used to determine the genetic variants associated with obstructive sleep apnea (OSA)and its co-morbidities.

Detailed description: The purpose of building the cohort is to allow the performance of genome-wide association studies with a large sample of patients that have been well-characterized using standardized procedures.

Eligibility criteria: Inclusion Criteria:

We will recruit subjects who are:

* 18 years of age and older.
* Willing and able to give informed consent

AND any of the following:

* PSG (polysomnogram)requested by a physician based on clinical grounds
* AHI (Apnea-hypopnea index) ≥ 5 episodes per hour based on a prior PSG.

Exclusion Criteria:

Incapable of giving informed consent

* Under the age of 18

Primary outcomes:
measure: Sleep Questionnaire
timeFrame: upon enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Suite 2600, Martha Morehouse Medical Pavilion
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ulysses Magalang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05939427: Improving Family Engagement in Acute Cardiovascular Care: The NGAGE Trial
Official title: Real-Time Feedback to Improve Family Engagement in Acute Cardiovascular Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Engagement
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to assess if the NGAGE real-time feedback tool improves family engagement in family members of people admitted to an acute cardiac care unit

The investigators will randomize 88 family members of people hospitalized in the acute cardiac ward in a 1:1 manner to either the NGAGE intervention or usual care. Family members will be eligible if the expected unit stay of their loved one is \>48 hours and if they can communicate in English or French. A family member is considered anyone with a biological, emotional, or legal relationship with the patient whom the patient wishes to be involved in their care. The primary outcome of the study will be the FAMily Engagement (FAME) score at hospital discharge. Secondary outcomes will be family mental health (by HADS score) and family care satisfaction (by FS-ICU score).


Eligibility criteria: Inclusion Criteria:

* Family member of CV patient with expected stay \> 48 hours (as per treating team)
* Aged of at least 18 years old
* Ability to communicate in English or French
* Willing to fill out the questionnaires as per the study

Exclusion Criteria:

* Expected stay of \< 48 hours
* Inability to communicate in English or French

Primary outcomes:
measure: Family Engagement (FAME) score
timeFrame: Within 48-hours of hospital discharge
Secondary outcomes:
measure: Mental health
timeFrame: Within 48-hours of hospital discharge
measure: Family satisfaction
timeFrame: Within 48-hours of hospital discharge
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Ladis Davis Institute
state: Quebec
Study officials:
affiliation: Lady Davis Institute, McGill University, Jewish General Hospital
name: Michael Goldfarb, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05253027: Foreign Body Swallows in Pediatrics
Official title: Foreign Body Swallows With Airway Affection in Pediatrics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foreign Body in Oropharynx
Keywords: Foreign Bodies
Child
Respiratory distress
Hypopharynx
Esophagoscopy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 14
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children between birth and 16 years of age

Brief summary: Foreign Body Ingestion (FBI) is a common clinical emergency in children. Most FBs smoothly pass through the digestive tract without complications; nevertheless, some FBs can cause severe morbidity and mortality. The current work aimed at evaluating how FBI can cause respiratory distress and stridor as well as their severity according to age, gender, lodgment site, and type of the object. Factors influencing morbidity and mortality among studied patients will be deliberated as well.

Detailed description: Background: Foreign Body Ingestion (FBI) is a common clinical emergency in children. Most FBs smoothly pass through the digestive tract without complications; nevertheless, some FBs can cause severe morbidity and mortality. The current work aimed at evaluating how the FBI can cause respiratory distress and stridor as well as their severity according to age, gender, lodgment site, and type of the object. Factors influencing morbidity and mortality among studied patients will be deliberated as well.

Methods: It is a hospital-based descriptive study where all children between birth and 16 years of age who were admitted from January 1 st, 2018 to December, 31th 2021 for FBs removal were analyzed. All cases were subjected to complete history taking, physical, radiological, and bronchoscopic examination.

Eligibility criteria: Inclusion Criteria:

* children between birth and 16 years of age FBs removal
* history suggestive of foreign body swallow

Exclusion criteria:

- none

Primary outcomes:
measure: Respiratory distress
timeFrame: 24 hour after presentation
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
References:
Clinical trial NCT00413127: Perioperative Protective Effects of Lidocaine
Official title: Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Elective Surgical Procedure
Colorectal Surgery
Keywords: Systemic lidocaine
peridural lidocaine
perioperative analgesia
inflammation
Anesthesia
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: International Anesthesia Research Society (IARS)
First posted: 2006-12-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to comparing effects of intravenously (IV) administered lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing elective colorectal surgery


Eligibility criteria: Inclusion Criteria:

* elective colorectal surgery

Exclusion Criteria:

* ASA \> 3
* history of anti-inflammatory therapy
* history of inflammatory bowl diseases
* history of chronic pain treatment

Primary outcomes:
measure: length of postoperative hospital stay
timeFrame: end of hospital stay
Secondary outcomes:
measure: Hyperalgesia perioperative
timeFrame: postoperative day 2, 4, 8, end of hospital stay and follow-up
measure: Cytokine levels perioperative
timeFrame: before surgery and 4 hours, 2 and 4 days after surgery
measure: Bowel motility perioperative
timeFrame: days after surgery
measure: Length of PACU stay
timeFrame: end of PACU stay
measure: Cognitive function perioperatively
timeFrame: before surgery, one and four days after surgery, at end of hospital stay and follow-up
measure: Incidence of wound healing disturbances
timeFrame: within 4 weeks after surgery
measure: Postoperative Analgesia
timeFrame: until end of hospital stay
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital Muenster
city: Muenster
country: Germany
facility: St. Franziskushospital Muenster
city: Vechta
country: Germany
facility: St. Marienhospital
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, University Hospital Muenster
name: K Hahnenkamp, MD
role: STUDY_CHAIR
References:
citation: Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.
citation: Cooke ED, Bowcock SA, Lloyd MJ, Pilcher MF. Intravenous lignocaine in prevention of deep venous thrombosis after elective hip surgery. Lancet. 1977 Oct 15;2(8042):797-9. doi: 10.1016/s0140-6736(77)90727-9.
Clinical trial NCT02903927: Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses
Official title: Prospective Comparative Randomized Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catartact
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 81
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601 PY for the monocular uncorrected distance visual acuity and compare it to the reference monofocal IOL Acrysof IQ SN60WF.


Eligibility criteria: Inclusion Criteria:

* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
* Patients of any gender, aged 50 to 90 years;
* Senile cataract in at least 1 eye;
* Assured follow-up examinations;
* Healthy eyes besides clinically significant cataract
* Biometry measurement/cataract density compatible with the IOLMaster evaluation.

Post-operative inclusion criteria:

* IOL implanted in the capsular bag;
* The IOL model (CT LUCIA 601PY or Acrysof IQ SN60WF) has been implanted;
* No intraoperative complications; no damaged capsular bag, no intraocular hemorrhage; no can opener rhexis.

Exclusion Criteria:

* • Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial;

  * Patients whose freedom is impaired by administrative or legal order;
  * Current participation in another drug or device investigation;
  * Allergy to heparin
  * Monophthalmic patient
  * Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse the operated eye
  * Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
  * Diabetic retinopathy
  * Traumatic cataract
  * Aniridia
  * Microphthalmus
  * Amblyopia
  * Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
  * Patient expected to require retinal laser treatment before the end of the follow-up
  * Previous intraocular and corneal surgery
  * Expected postop. astigmatism greater than 1 D
  * Any type of corneal disorder
  * Dementia
  * Diabetes mellitus
  * Pseudoexfoliation syndrome (PXF)
  * Glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
  * Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient

Primary outcomes:
measure: Uncorrected distance visual acuity (UCVA) (monocular)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02108327: Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA
Official title: Comparison of Blood Loss Between Surgical Blade and Unipolar Electrocautery in Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss
Keywords: Blood loss
total knee arthroplasty
hot knife
cold knife
unipolar electrocautery
surgical blade
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee Arthroplasty (TKA).


Eligibility criteria: Inclusion Criteria:

* osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
* age 50-85 years old
* ASA class 1-3

Exclusion Criteria:

* unable to perform spinal anaesthesia
* history of coagulation disorder
* renal impairment (CrCl \<30 mL/min) or cirrhosis
* platelet count \< 100,000 or abnormal coagulogram
* on pacemaker
* stop anti-platelet or anti-coagulogram less than 7 days

Primary outcomes:
measure: Blood loss
timeFrame: 48 hours
Secondary outcomes:
measure: inflammation
timeFrame: 48 hours
measure: Knee function
timeFrame: 3 months
measure: knee range of motion
timeFrame: 3 months
measure: complication
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Klongluang
country: Thailand
facility: Orthopaedic department, Faculty of medicine, Thammasat university
state: Pathumthani
Study officials:
References:
citation: Tammachote N, Kanitnate S. Electric cautery does not reduce blood loss in primary total knee arthroplasty compared with scalpel only surgery a double-blinded randomized controlled trial. Int Orthop. 2018 Dec;42(12):2755-2760. doi: 10.1007/s00264-018-4048-y. Epub 2018 Jul 3.
Clinical trial NCT01922427: Study of RNS60 on Pain and Function After Knee Anterior Cruciate Ligament Surgery
Official title: Study of RNS60 on Post-operative Pain and Function in Patients Undergoing Knee Anterior Cruciate Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: Revalesio Corporation
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if use of RNS60 during ACL reconstruction surgery decreases pain and improves functional capacity post-operation.



Primary outcomes:
measure: Assessment of Post-operative pain
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03236727: SSEP Fluctuations Due to Dexmedetomidine During Posterior Spine Fusion
Official title: SSEP Fluctuations Due to Dexmedetomidine During Posterior Spine Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Fusion
Keywords: Dexmedetomidine, spinal fusion, SSEP
Lead sponsor: George Papanicolaou Hospital
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intravenous anesthetic agents as far as inhaled agents produce a dose depended increase in latency and decrease in amplitude of SomatoSensory Evoked Potential (SSEP). Dexmetedomidine, a highly selective a2 adrenergic agonist, not only minimizes the anesthetic agents but also the opioids, reducing the analgesic demands. The effect of dexmedetomidine on SSEP has not been elucidated. We aimed to investigate alterations on somatosensory SSEP in adults during posterior spinal fusion surgery before and after Dexmedetomidine administration.

Detailed description: Patients 18-75 years old, ASA (physical status classification system) I-III, scheduled for elective posterior spinal fusion surgery were enrolled in this prospective study. After induction in anesthesia, it was applied SSEP monitoring and a baseline test was performed after 15min (in order to wash out the propofol used for induction). Infusion of Dexmedetomidine was started at a bolus dose of 1mcg/Kg following by 0.7mcg/Kg. Bispectral Index (BIS) monitored the depth of anesthesia and an adequate level (40-50) of anesthesia was maintained by sevoflurane. SSEP were recorded intraoperatively from the tibial nerve (P37) and data were analyzed over that period.

Eligibility criteria: Inclusion Criteria:

* Patients with ASA physical status 1-3

Exclusion Criteria:

* Patients with ASA physical status \>3,
* Body Mass Index (BMI) over 30,
* indication for rapid sequence induction,
* any contraindication for receiving b-blocker,
* Glasgow Coma Scale (GCS) \<13,
* history of drug abuse,
* neurologic deficit or preoperatively foreseen delayed extubation,
* preoperative heart rate\<45.

Primary outcomes:
measure: SSEPs
timeFrame: 10 min after starting infusion of dexmedetomidine
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: