louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05265923: A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis
Official title: A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Patients With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in patients with moderate-to-severe atopic dermatitis.

Detailed description: The study consists of an up-to-4-week screening period, a 16-week double-blind treatment period, a 36-week maintenance treatment period, and a 8-week safety follow-up period.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Organ dysfunction.
* pregnancy.
* Other.

Primary outcomes:
measure: Proportion of subjects achieving EASI-75 at week 16
timeFrame: 16 weeks
measure: Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 16
timeFrame: 16 weeks
Secondary outcomes:
measure: Incidence of adverse events (AEs), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
timeFrame: 64 weeks
measure: Percent change of EASI score from baseline
timeFrame: 52 weeks
measure: Percent change of NRS score from baseline
timeFrame: 52 weeks
measure: Body surface area (BSA) of involvement of atopic dermatitis
timeFrame: 52 weeks
measure: Changes from baseline in Dermatology Life Quality Index (DLQI)
timeFrame: 52 weeks
measure: Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
timeFrame: 64 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's hospital
Study officials:
affiliation: Peking University People's Hospital
name: jianzhong zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05171023: Application of ROTEM Technology in Aortic Surgery
Official title: Application of ROTEM Technology in Aortic Surgery Under Cardiopulmonary Bypass and Circulatory Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Surgery
Coagulation Management
Keywords: ROTEM
coagulation tests
coagulation disorders
aortic surgery
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after surgical interventions on the aorta with cardiopulmonary bypass and/or circulatory arrest.

Brief summary: Comparison of the diagnostic capabilities of rotational thromboelastometry (ROTEM) and standard coagulogram in the detection of disorder and correction of the hemostasis system in the perioperative period in patients who underwent surgical intervention on the aorta under cardiopulmonary bypass and or circulatory arrest.

Detailed description: The patient is monitored in the intensive care unit according to the following scheme: ROTEM (NATEM, INTEM, EXTEM, FIBTEM; with high clotting time (CT) values in INTEM - HEPTEM is done) and a coagulogram (activated coagulation time (ACT), activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen, antithrombin III, platelet aggregation) are done on admission and after 6 hours - with a smooth course of the perioperative period. If it is necessary or the development of disorders in the form of bleeding or thrombosis that require correction, ROTEM and a coagulogram are done, treatment is carried out, and after elimination of the causes, ROTEM and a coagulogram are examined in dynamics to assess the effectiveness of the therapy.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 80 years.
* Patients after surgical interventions on the aorta with cardiopulmonary bypass and/or circulatory arrest (operations on the ascending aorta, aortic arch and thoracoabdominal aorta).

Exclusion Criteria:

* Patients with other cardiac surgery, including isolated endovascular interventions on the aorta.

Primary outcomes:
measure: The coagulation index
timeFrame: an average of during the first day after surgery
measure: Activated coagulation time
timeFrame: an average of during the first day after surgery
Secondary outcomes:
measure: Percentage of repeated operations
timeFrame: an average of 24 hours after surgery
measure: Percentage of multiple organ failure
timeFrame: an average of 24 hours after surgery
measure: Percentage of serious infectious complication
timeFrame: an average of 24 hours after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky National Research Centre of Surgery
Study officials:
affiliation: Petrovsky National Research Centre of Surgery
name: Aleksandr Eremenko, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01198223: Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis
Official title: Comparison of Therapeutic Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Denture Stomatitis
Keywords: denture stomatitis
nystatin
garlic
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to compare the effect of aqueous extract of garlic with nystatin mouthwash in denture stomatitis.

Detailed description: Denture stomatitis is the most common form of chronic oral candidiasis manifested as chronic inflammation of the mucous membrane t supporting the movable prosthesis that may have a local or systemic nature. This inflammation is presented as mucous erythema and occasionally with pain and burning. The standard treatment for denture stomatitis is administration of nystatin which is accompanied with complications such as bitter taste as well as the high number of drug application that result in reduced tendency of patients in using this medication hence, efforts are continuously being made to substitute other types of therapies for this condition.

Eligibility criteria: Inclusion Criteria:

* 40 years of age and older
* confirm of denture stomatitis by the oral medicine specialists

Exclusion Criteria:

* Patients with a history of using anti-fungal drugs, antibiotics, and corticosteroid within the previous month
* allergy to garlic and nystatin mouthwash
* immunodeficiency
* uncontrolled diabetes
* those with garlic rich diet
* inability in using mouthwash
* loose and discolored dentures
* psychologic disorder and alzheimer

Primary outcomes:
measure: reduction of diameter of erythematous lesion under denture
timeFrame: first week
Secondary outcomes:
measure: complete relief of erythematous lesions
timeFrame: fourth week
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: QUMS
Study officials:
affiliation: Qazvin University of Medical Science
name: mahin bakhshi, DDS,MS
role: STUDY_CHAIR
affiliation: Shahid Beheshti University of Medical Science
name: Jamileh bigom Taheri, DDS/MS
role: STUDY_DIRECTOR
affiliation: QUMS
name: Samira Basir Shabestari, DDS/MS
role: PRINCIPAL_INVESTIGATOR
affiliation: QUMS
name: Rozbeh Pahlevan, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: QUMS
name: Anet Tanic, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01602523: Effect of Symbicort on Sleep Quality in Patients With Emphysema
Official title: Effect of Symbicort on Sleep Quality in Patients With Emphysema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Emphysema
Poor Sleep Quality
Keywords: Emphysema
COPD
Sleep
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2012-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an inhaled medication that contains 2 drugs. One is a medication that opens up the airways (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort is not an experimental medication. It is approved by the Food and Drug Administration for use in patients with emphysema. Patients with severe emphysema commonly sleep poorly. The cause of poor sleep in these patients is unknown. Symbicort may improve sleep quality by opening the airways and reducing lung inflammation. It is not known for sure if these effects actually improve sleep and quality of life. It is hoped that this study will answer this question.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe emphysema (GOLD stages 2 and 3)

Exclusion Criteria:

* Use of supplemental oxygen,
* A recent COPD exacerbation within the past 4 weeks.
* A previous diagnosis of obstructive sleep apnea
* A known urinary outflow obstruction,
* Glaucoma
* History of an allergic reaction to one of the study medications.

Primary outcomes:
measure: The primary outcome is the objective assessment of sleep quality.
timeFrame: 28 days
Secondary outcomes:
measure: Secondary outcome includes assessment of nocturnal oxygenation.
timeFrame: 28 days
measure: Secondary outcome is the subjective assessment of sleep quality.
timeFrame: 28 days
measure: Secondary outcome includes assessment respiratory mechanics/function.
timeFrame: 28 days
measure: Secondary outcome includes assessment of overall quality of life.
timeFrame: 28 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple Lung Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02312323: One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses
Official title: One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: Contamac Ltd
Sponsor class: INDUSTRY
Collaborators: name: Hartwig Research Center
First posted: 2014-12-09
Enrollment: 35
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: Comparison of different contact lens materials.

Detailed description: This is a 1-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.

Eligibility criteria: Inclusion Criteria:

* willing and able to sign informed consent form
* ages 18 years or older
* Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
* Spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
* Astigmatic power ≤0.75 D

Exclusion Criteria:

* Eye injury or surgery within 3 months immediately prior to enrolment for this trial
* Pre-existing ocular irritation that would preclude contact lens fitting
* Currently enrolled in an ophthalmic clinical trial
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
* Any use of medications for which contact lens wear could be contradicted, as determined by the investigator
* Current extended-wear users (sleep-in overnight)
* Current monovision lens wearers
* Pregnant women and nursing mothers
* Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)

Primary outcomes:
measure: questionnaire addressing subjective comfort and wear time
timeFrame: subjects will be followed-up for one month
measure: limbal redness - ocular biomicroscopy
timeFrame: subjects will be followed-up for one month
measure: conjunctival redness - ocular biomicroscopy
timeFrame: subjects will be followed-up for one month
measure: corneal staining - ocular biomicroscopy
timeFrame: subjects will be followed-up for one month
Secondary outcomes:
Other outcomes:
Locations:
city: Kassel
country: Germany
facility: Siehste
city: Würzburg
country: Germany
facility: Kresinky
Study officials:
affiliation: Hartwig Research Center
name: Andreas Hartwig, PhD, FAAO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00536523: Effect of Serotonin Level on Constipation Caused by Chemotherapy in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official title: Women's Cancer Center Protocol #52: Alterations in Serum Serotonin Levels as a Mechanism for Chemotherapy Induced Constipation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Constipation
Bowel Obstruction
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Keywords: constipation, impaction, and bowel obstruction
ovarian epithelial cancer
peritoneal cavity cancer
fallopian tube cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2007-09-28
Enrollment: 13
Sex: FEMALE
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: Women with newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer.

Brief summary: RATIONALE: Gathering information about changes in serotonin levels in patients undergoing chemotherapy for ovarian cancer, fallopian tube cancer, or primary peritoneal cancer may help doctors learn more about constipation caused by chemotherapy.

PURPOSE: This clinical trial is studying how blood levels of serotonin effect constipation caused by chemotherapy in patients with newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed description: OBJECTIVES:

* To determine if there are any alterations in serotonin levels in patients undergoing chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer and if this is associated with increased constipation.

OUTLINE: Patients undergo blood sample collection prior to beginning of planned postoperative chemotherapy, after 3 and 6 courses of chemotherapy, and at the 3-month surveillance visit. Patients also complete a bowel function questionnaire at these time points.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer
* Planned to undergo 6 courses of a taxane and platinum-containing regimen

Exclusion Criteria:

* Ovarian low malignant potential tumor
* History of constipation or irritable bowel syndrome
* History of colorectal cancer
* Prior bowel resection at time of staging/cytoreductive surgery
* Prior abdominal-pelvic radiation
* Prior bowel surgery

Primary outcomes:
measure: Alterations in serotonin levels associated with increased constipation
timeFrame: PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Melissa A. Geller, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05714423: Outcomes in Lower Pole Kidney Stone Management Using Mini-PCNL Compared With Retrograde Intra Renal Surgery
Official title: Outcomes in Lower Pole Kidney Stone Management Using Mini-PCNL Compared With Retrograde Intra Renal Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Keywords: lower pole stone, mini PCNL, retrograde intrarenal surgery
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2023-02-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Due to the anatomic characteristics of the lower calyx, lower pole stones are difficult to be eliminated through the ureter, even if the stones had been fragmented. Retrograde intrarenal surgery (RIRS) can be used to deal with lower pole stones of 1.0-2.0 cm, while percutaneous nephrolithotripsy (PCNL) is mainly used to deal with lower pole stones with larger diameter or when RIRS failed to resolve the stone. This study was conducted to compare mini PCNL and retrograde intrarenal surgery (RIRS) for the management of lower pole kidney stones in terms of efficacy.


Eligibility criteria: Inclusion Criteria:

* Renal stone at lower pole of size 10mm -20mm

Exclusion Criteria:

* Patients with positive urine culture,
* Patients with anatomical abnormalities determined by ultrasonography
* Uncontrolled diabetes (HbA1c \>9%)
* Patients undergone previous renal surgery

Primary outcomes:
measure: Stone Clearance
timeFrame: 4 weeks
Secondary outcomes:
measure: Hospital Stay
timeFrame: 1 week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaikh Zayed Hospital Lahore
state: Punjab
Study officials:
References:
Clinical trial NCT03723538: Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery
Official title: Efficacy and Safety of Dexmedetomidine Sedation in Spontaneous Breathing Patients After Tracheal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Sedation
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for elective tracheal resection and reconstruction surgery and admitted to ICU after surgery

Brief summary: Patients undergoing tracheal resection and reconstruction surgery are enrolled in this prospective observational pilot study to evaluate dexmedetomidine-based sedation after tracheal surgery in an Intensive Care Unit (ICU). Patients remain electively intubated with an uncuffed nasal endotracheal tube, awake and exhibit spontaneous breathing The neck was maintained in flexion through chin-to-chest sutures. Infusion of dexmedetomidine was started from a dosage of 0.7 μg kg-1 h-1 followed by dose titration to the target level of the sedation Richmond Agitation Sedation Scale, (RASS) score -1/-2 using a dose range of 0.2-1.4 μg kg-1 h-1.


Eligibility criteria: Inclusion Criteria:

* patients submitted to tracheal surgery
* elective surgery
* age ≥ 18 years

Exclusion Criteria:

* severe neurological disorder
* visual or hearing impairment
* acute cerebrovascular disease
* mean arterial pressure (MAP) \<55 mmHg or hypotension requiring the use of inotropes/vasopressors
* heart rate (HR) \<50 bpm
* second and third degree atrioventricular block (AV block) in the absence of PMK
* Sequential Organ Failure Assessment (SOFA) score \<2 index
* hepatic failure
* emergency surgery
* pregnancy
* patient refusal to give consent
* inability to give consent
* age ≤18 years
* ASA score ≥ IV.

Primary outcomes:
measure: The primary endpoint is the efficacy in changing the sedation level during the infusion
timeFrame: at T0 (baseline) and 12 hours from the beginning of the infusion
Secondary outcomes:
measure: The secondary endpoint is evaluation of safety throughout the incidence of adverse effects during the infusion
timeFrame: at T0 (baseline), 3, 6, 12 and 18 hours from the beginning of the infusion)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: azienda ospedaliero universitaria Sant'Andrea
Study officials:
References:
Clinical trial NCT05608538: Evaluation of Nutritional Scores as Predictive Factors of Postoperative Outcome After Pancreatic Surgery
Official title: Evaluation of Nutritional Scores as Predictive Factors of Postoperative Outcome After Pancreatic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic and Peripancreatic Tumors
Keywords: Pancreatic cancer
Pancreaticoduodenotomy
Nutritional assessment score
Malnutrition
Pancreatic surgery
Distal resection
Total resection
Oncology
Clinica trial
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 300
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: The population of the study consists of consecutive patients, aged between 18 and 90, that will undergo major pancreatic surgery at the General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital.

Brief summary: Patients scheduled for major pancreatic surgery will be screened for malnutrition by five screening scores chosen depending on their clinical applicability. After surgery, it will be evaluated which score predicts the best complications.

Detailed description: Patients scheduled for major pancreatic surgery (pancreaticoduodenectomy, distal resection, total resection) will be screened for malnutrition by the following screening scores: Nutritional Risk Screening Score 2002; Subjective Global Assessment; Malnutrition Universal Screening Tool; Mini Nutritional Assessment and Short Nutritional Assessment Questionnaire.

The postoperative outcome will be recorded, and the predictive value of each score will be calculated.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 90 years undergoing major pancreatic resections (pancreaticoduodenectomy, distal pancreatic resection, total pancreatic resection) are eligible for inclusion. All patients are informed orally about all aspects of the trial. All conditions leading to primary pancreatic resection are eligible.

Exclusion Criteria:

* patients undergoing minor pancreatic resections.

Primary outcomes:
measure: Evaluation of nutritional assessment score as predictive of pancreatic surgery outcomes
timeFrame: The nutritional assessment scores are administred between 15 and 1 day before the operation. The evaluation of outcomes ends when patient are dismissed.
Secondary outcomes:
measure: The correlation between nutritional scores and postoperative outcomes is based on age, type of disease, possible preoperative oncological treatments, and operation technique.
timeFrame: The nutritional assessment scores are administred between 15 and 1 day before the operation. The evaluation of outcomes ends when patient are dismissed.
Other outcomes:
Locations:
city: Verona
country: Italy
facility: General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital
Study officials:
References: