louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01911962: A Prospective Randomized Controlled Study of Natural Orifice Medium-low Rectal Endometriosis Resection
Official title: A Prospective Randomized Controlled Study of Natural Orifice Medium-low Rectal Endometriosis Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Rectal Resection
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients

Brief summary: To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.

Detailed description: To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.Both of the two kinds of surgery is conventional,but the comparison is still unclear.The investigators divide the patients into two groups, and compare the differences of postoperative outcomes by statistics.

Eligibility criteria: Inclusion Criteria:

Childbearing age women,

older than 18 years,

diagnosed with intestinal endometriosis,

rectum clinical symptoms for invalid medical treatment,

dysmenorrhea, dyspareunia dyschezia, infertility, defecate carries blood,

endometriosis in the lower rectum by intraoperative judgment

Exclusion Criteria:

without endometriosis rectum,

history of colorectal surgery,

intolerance to laparoscopic surgery

Primary outcomes:
measure: rectovaginal fistula
timeFrame: one year
Secondary outcomes:
measure: postoperative constipation
timeFrame: one year
measure: postoperative uroschesis
timeFrame: one year
measure: intestinal obstruction
timeFrame: one year
measure: surgical wound infection
timeFrame: one year
Other outcomes:
measure: dyspareunia
timeFrame: one year
Locations:
Study officials:
affiliation: First Affiliated Hospital of Sun Yat-sen University
name: Yao Shuzhong, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05559762: Impact of Night Shift Work on 24-hour Blood Glucose Levels
Official title: Impact of Regular Night Shift Work on 24-hour Blood Glucose Levels in Nurses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circadian Rhythm; Inversion
Metabolic Disease
Lead sponsor: Lincoln Memorial University
Sponsor class: OTHER
Collaborators: name: Providence St Joseph Health
First posted: 2022-09-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full time nurses working either day shifts or night shifts

Brief summary: This study will determine whether nurses regularly working night shifts have elevated 24-hour glucose levels compared to nurses regularly working day shifts, using continuous glucose monitoring (CGM).


Eligibility criteria: Inclusion Criteria:

* • RNs working at least a 0.6 FTE and 12-hour night or day shift (not able to alternate between days and nights) for at least the past two months

  * Free from presence of uncontrolled chronic illness and specifically prediabetes, Type 1 or Type 2 diabetes (but not including history of gestational diabetes) and not currently taking any glucose-lowering or steroid medication
  * Not currently pregnant or breastfeeding
  * English speaking and able to provide informed consent
  * Must own and know how to operate a Smartphone
  * Must be willing and able to wear two small sensors attached by adhesive for the study duration, the Fibion SENS activity monitor and the Dexcom G6 continuous glucose monitor
  * Must regularly consume food during shifts and refrain from actively attempting weight loss during the study duration
  * Must work only one job at the time of study participation

Primary outcomes:
measure: 24hr glucose
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Providence Sacred Heart Hospital
state: Washington
Study officials:
affiliation: Lincoln Memorial University
name: Lindsey Miller
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04524962: Study of Descartes-30 in Acute Respiratory Distress Syndrome
Official title: Phase I/IIA Study of Descartes-30 in Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Respiratory Distress Syndrome
Covid19
Lead sponsor: Cartesian Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-08-24
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: TREATMENT

Brief summary: Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older at the time of enrollment
* Patient maintains a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS

Exclusion Criteria:

* Patient is currently enrolled into another therapeutic clinical trial with an experimental therapy that has not received marketing approval by U.S. FDA.
* Patient is in moribund state with expected survival \<24 hours.

Primary outcomes:
measure: To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Medical Center Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT05602662: Music as a Complement to Pharmacological Sedation in Ventilator Treated ICU Patients.
Official title: Music as a Complement to Pharmacological Sedation in Ventilator Treated ICU Patients - Prospective Randomized Cross-over Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Music Therapy
Keywords: Music therapy, Ventilator treated patients, Need of sedation.
Lead sponsor: Karlstad Central Hospital
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Can music theraphy during mechanical ventilation in the ICU, decrease the need of pharmacological sedation? Included patients will listen to music selected by a music therapist via headphones two times one hour during two days. Effects on heart rate, blood pressure, respiratory rate and dosing of pharmacological sedation will be observed. 100 patients will be included and radomized equally to earphones with and without music.


Eligibility criteria: Inclusion Criteria: In the ICU, entilator treated adults \> 18 years.

-

Exclusion Criteria:

* Children \>18 years.
* Deaf people.
* Children \<18 Years

Primary outcomes:
measure: Changed dose of sedatives,
timeFrame: 2 times one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Karlstad
country: Sweden
facility: Department of Anesthesia & Intensive Care
state: Värmland
Study officials:
References:
Clinical trial NCT04586062: Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population
Official title: Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Ligneous Conjunctivitis
Lead sponsor: Kedrion S.p.A.
Sponsor class: INDUSTRY
First posted: 2020-10-14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this protocol is to provide compassionate use of Kedrion Human Plasminogen Ophthalmologic Drops to an expanded population of patients diagnosed with ligneous conjunctivitis associated with type I Plasminogen deficiency until product licensure, and/or until a new clinical trial is available and the patients in treatment under Expanded Access are eligible to participate in the new trial.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with LC associated with Type I plasminogen deficiency, confirmed by laboratory documentation at screening visit, with or without ocular pseudomembranes. The presence of membranes in different areas is not an exclusion criterion.
* Subjects and their legally authorized representative, in the case of subjects \<18 years of age, should be informed of the nature of the treatment, agree to its provision, sign and date the informed and data handling consent forms approved by the IRB.
* Subjects must be available for the duration of the treatment and agree to be compliant with the protocol visit and follow-up schedule.
* Subjects agree to keep the treating physician or specialist in charge informed about any occurrence related to the treatment.

Exclusion Criteria:

* Subjects with any condition which, in the opinion of the treating physician or specialist in charge might interfere with the treatment.
* Females of childbearing potential who are either pregnant or not using an adequate method of birth control (adequate is defined as hormonal contraceptive or partner vasectomy for at least 3 months, condoms, intrauterine device \[IUD\], abstinence or other prescribed birth control). Enrolled males must agree to utilize appropriate contraceptive methods to prevent pregnancy in partners.
* Females who are breastfeeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02584062: Clinical Observation of Technologic Application of No-touch Fluid-air Exchange in Surgery of Idiopathic Macula Hole
Official title: The Eye Hospital of Tianjin Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Macula Hole
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
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 observe the technologic application of no-touch fluid-air exchange in Surgery of Idiopathic Macula Hole.


Eligibility criteria: Inclusion Criteria:

* All patients were diagnosed as having an idiopathic macular hole(IMH) by Optical Coherence Tomography(OCT).

Exclusion Criteria:

* Myopia of \>6 diopters
* Ocular trauma and other systematic or ocular issues associated with IMHs，such as the other macula disease, for example the degeneration of macula.

Primary outcomes:
measure: the closure rate of Macular hole
timeFrame: one month
measure: the closure rate of Macular hole
timeFrame: three month
measure: the closure rate of Macular hole
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin medical university eye hosipital
state: Tianjin
Study officials:
References:
Clinical trial NCT02002962: Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter
Official title: Radiofrequency Ablation Plus Botulinum Toxin Injection Versus Radiofrequency Ablation Only in Patients With Atrial Flutter to Prevent Post-procedural Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atrial Flutter
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized study was to assess the effectiveness of endomyocardial botulinum toxin injection for preventing post-procedural atrial fibrillation in patients undergoing the radiofrequency ablation of atrial flutter.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* ECG documented paroxysmal or persistent AFL
* No prior documented history of AF
* Patient undergoing RFA of AFL.
* No indication (other than AFL) for continued anticoagulation with warfarin.
* No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device)

Exclusion Criteria:

* A history of atrial fibrillation
* Previous AF ablation procedure
* Congestive heart failure
* Left Ventricle ejection fraction less than 35%
* Unwillingness to participate

Primary outcomes:
measure: number of paroxysms of atrial fibrillation
timeFrame: 1 year
Secondary outcomes:
measure: AF burden
timeFrame: 1 year
measure: serious adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
References:
Clinical trial NCT00757562: Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)
Official title: Multiple-Dose Safety and Tolerance Study of Desloratadine in Atopic Pediatric Subjects and Pediatric Subjects With Chronic Idiopathic Urticaria, Ages >=2 to <12 Years, Who Are Poor Metabolizers of Desloratadine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Idiopathic Urticaria
Atopy
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 97
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives. All of the subjects enrolled in this trial were previously identified in an earlier trial to be poor metabolizers of desloratadine.


Eligibility criteria: Inclusion Criteria:

Subjects must:

* have been previously identified through the previous study P03031 to be atopic or with chronic idiopathic urticaria and be a poor metabolizer of desloratadine.
* have clinical laboratory tests within normal limits.
* be in good health, free of any clinically significant disease that could interfere with the study.
* normal 12-lead ECG

Exclusion Criteria:

Subjects who:

* have a history of any clinically significant local or systemic infectious disease within 4 weeks prior to treatment.
* have taken any medication that is restricted by the protocol or failed to satisfy washout requirements.
* are allergic to desloratadine.
* have used a loratadine- or desloratadine-containing product within the past 30 days.
* are female and menstruating.

Primary outcomes:
measure: Safety and Tolerance
timeFrame: Weekly throughout the 5-week study (Day 1, Day 8, Day 15, Day 22, Day 29, and Day 36).
Secondary outcomes:
measure: Plasma concentration data (of desloratadine to loratadine) prior to administration of desloratadine on Days 15 and Days 36.
timeFrame: Days 15 and Days 36
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02762162: Registry of Coronary Artery Ill Patients With Platelet Test Results
Official title: Online Assistance for Stent Thrombosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Myocardial Infarction
Keywords: antiplatelet
stent thrombosis
Lead sponsor: Action, France
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: coronary ill patients who have had a functionnal test mesuring antiplatelet effect and / or a genetic profile of response to antiplatelet drugs.

Brief summary: ONASSIST is a registry of coronary ill patients who have had a functional test measuring anti-platelet effect and/or a genetic profile of response to anti-platelet drugs.

Detailed description: The Onassist Project is an assistance for cardiologists that establishes an individual risk of stent thrombosis for each patient based on:

* a functional approach (evaluation of the antiplatelet effect of the antiplatelet regimen by multiple tests) and
* a pharmacogenomic approach (genetic profile of response to antiplatelet agents) It provides advices for specific therapeutics after identification of adverse drug interactions, treatment compliance issues and true genetic, functional or mixed resistance.

This individualized strategy allow to adjust the choice of the drugs and their optimal dosage considering the best benefit - risk ratio.

Follow up are regularly made to identify markers of MACE (major adverse cardiac event) or bleeding.

Eligibility criteria: Inclusion Criteria:

* coronary disease
* antiplatelets testing performed as part of usual care and / or gentic profile of antiplatelet response done

Exclusion Criteria:

* patient refusing to be part of the registry

Primary outcomes:
measure: Bleeding
timeFrame: 10 years
measure: Myocardial Infarction
timeFrame: 10 years
measure: Death
timeFrame: 10 years
measure: Stroke
timeFrame: 10 years
measure: Urgent Revascularization
timeFrame: 10 years
measure: Resuscitated Cardiac Arrest
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Pitie Salpetriere
Study officials:
References:
Clinical trial NCT01766362: Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
Official title: Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Type 1 or 2 With Diabetic Retinopathy
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 83
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 show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.


Eligibility criteria: Inclusion Criteria:

* Diabetes type 1 or 2
* Subjects with severe non-proliferative or early proliferative diabetic retinopathy (according to the Alfediam classification)
* Subjects with central macular thickness less than or equal to 350 µm according to spetralis OCT
* Subjects registered with a social security agency
* Subjects who have provided written informed consent
* Subjects aged 18 or above

Exclusion Criteria:

* Pregnancy
* Breastfeeding women
* Patients presenting a contra-indication to Mydriaticum and Neosynephrine
* History of glaucoma or non-controlled ocular hypertension
* Blindness in one eye
* History of renal insufficiency requiring dialysis, or kidney or pancreas transplantation
* Unbalanced diabetes requiring, in the previous 4 months, intensive insulin therapy.
* Central macular thickness greater than 350 µm
* Visual acuity less than 20/32 measured using an ETDRS chart
* Proliferative diabetic retinopathy associated with "high risk factors" (extensive prepapillary neovessels and/or preretinal or prepapillary neovessels associated with preretinal of intravitreal hemorrhage)
* Macular edema due to causes other than diabetic retinopathy (venous occlusion, uveitis) or occurring in a context of vitreomacular traction
* Already started PRPC
* History of eye surgery or YAG laser capsulotomy performed during the preceding 6 months
* Subjects under legal supervision or guardianship

Primary outcomes:
measure: Macular thickness
timeFrame: 9 months after the start of traitement
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
city: Lyon
country: France
facility: CHU de la Croix Rousse
city: Paris
country: France
facility: Hôpital Lariboisière
Study officials:
References:
Clinical trial NCT04730362: Effect of Laryngeal Mask Airway on Image Quality n Pediatric Patients Undergoing Magnetic Resonant Imaging
Official title: Effect of Laryngeal Mask Airway on Image Quality n Pediatric Patients Undergoing Magnetic Resonant Imaging: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Obstruction
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group : a Guedel oral airway will be inserted for airway management versus supraglottic group patients in which supraglottic airway laryngeal mask airway (LMA) will be used
Primary purpose: PREVENTION

Brief summary: This study compare the effects of Oral airway vs LMA in preventing anesthesia-induced partial airway obstruction, in an attempt to lessen MRI motion artifacts, which would result in improvements in image quality.

Detailed description: Magnetic resonance image (MRI) is a frequently used imaging technique especially in oncological patients, where it is used for diagnosis, following up response to treatment and later for detection of possible recurrence. The main problem encountered with MRI is the long time required for completion of the imaging, during which the patient is required to lie still. Patients who are unable to lie still require sedation or general anesthesia (GA). Almost all pediatric patients are uncooperative, making GA, the standard of care for pediatric MRI.

Several general anesthetic techniques including airway management by endotracheal tube \& various supraglottic devices (LMA) have been described. Choice of technique by anesthesiologist is influenced by the patient's age, craniofacial and airway anatomy, procedure duration, \& illness acuity.

Eligibility criteria: Inclusion Criteria:

* ASA І and II patients
* Age under 18 years .
* The patient will need GA and patient Scheduled for MRI brain.

Exclusion Criteria:

* Glasgow coma scale ≤ 8
* Emergency patient with full stomach.
* Distorted upper airway anatomy making intubation with GA mandatory.

Primary outcomes:
measure: Image quality of each MRI sequence
timeFrame: During general anesthesia of MRI investigation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nataional Cancer Instituite
Study officials:
References: