louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04088526: Survey and Reduction of Mortality in Peridialysis Uremic Patients Via Intervention of Risk Factors
Official title: Survey and Reduction of Mortality in Uremic Patients During Peridialysis Period Via Intervention of Risk Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: In patients with non-dialysis-dependent end stage kidney disease (ESKD) the common transition of care to renal replacement therapy is dialysis. Each year over 70 000 Chinese transition from non-dialysis-dependent ESKD to dialysis. Whereas dialysis therapy is intended to be life-sustaining, ESKD patients have a 10-fold or higher risk of death compared with the general population. Mortality rates are even higher upon transition and in the first year, especially in the first 3 to 6 months following the transition to dialysis, yet it remains unknown which is the contributing cause of this high death rate. Hence, there is an urgent need to examine the emerging field of Transition of Care in ESKD. We suggest the term "peridialysis period" for this transition period for ESKD patients, so that the transition of care from non-dialysis-dependent ESKD to dialysis ESKD can be more pragmatically defined and studied. In the current study, we will investigate the mortality and its risk factors of ESKD patients during peridialysis period, and improve the survival rate and quality of life of peridialysis ESKD patients by intervening the risk factors.


Eligibility criteria: Inclusion Criteria:

* Patients who have been diagnosed with end stage kidney disease (eGFR\<15ml/min/1.73m2) or newly started dialysis with 3 months at all hospitals in Yangzhou, China since January 1, 2016

Exclusion Criteria:

* Patients who have had a history of dialysis and have been transferred to Yangzhou during this period;
* patients who are transferred to a dialysis area outside Yangzhou City
* Patients who give up dialysis treatment
* patient whose renal function recover and stop dialysis treatment;
* Patient who receive kidney transplantation

Primary outcomes:
measure: mortality
timeFrame: one year
Secondary outcomes:
measure: hospitalization
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrology, Shanghai Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Changlin Mei, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04526626: Endovenous RFA Versus Ligation and Striping for Varicose Veins
Official title: Endovenous Radiofrequency Ablation Versus High Ligation and Striping for Treatment of Varicose Veins: a Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Veins of Lower Limb
Keywords: Radiofrequency ablation
High ligation and striping
Lead sponsor: The University of Hong Kong-Shenzhen Hospital
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Varicose vein is a common chronic disease affecting patient's quality of life. High ligation and stripping of the long saphenous vein is the traditional operation for varicose vein. The radiofrequency ablation (RFA) device used for treatment of varicose vein has been available in China since 2014. There are few studies comparing RFA and stripping in the treatment of varicose vein. This study was to investigate the outcomes of RFA and stripping for varicose vein. Patients with varicose veins will be prospectively allocated to RFA group and stripping group. Ultrasound follow-up will be performed to assess recanalization of long saphenous vein at 1 month, 3, 6 and 12 months. Recurrence of varicose vein and improvement of symptoms will also be evaluated. The primary endpoints are technical success, complications and recurrence of varicose vein. Secondary endpoints are duration of operation, blood loss, recovery time, venous clinical severity score, and medical cost. The treatment outcomes will be compared between the RFA group and stripping group. RFA is comparable to traditional stripping in the treatment of varicose vein, however, it is associated quick recovery, lower incidence of complications and higher medical cost.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of long saphenous varicose veins

Exclusion Criteria:

* Contraindicated to operation due to severe comorbidities

Primary outcomes:
measure: Technical success
timeFrame: up to 24 months
measure: Complications
timeFrame: 2 weeks after operation
measure: Recurrence of varicose vein
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: University of Hong Kong Shenzhen Hospital
state: Guangdong
Study officials:
affiliation: The University of Hong Kong-Shenzhen Hospital
name: Hailei Li, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02445326: OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Official title: A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Allergic Conjunctivitis
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2015-05-15
Enrollment: 73
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: The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis


Eligibility criteria: Inclusion Criteria:

* Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
* Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

* History of refractive surgery (including LASIK procedures)
* History of retinal detachment, diabetic retinopathy, or active retinal disease
* Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
* Use any of the disallowed medications during the period indicated
* History of IOP increase as a result of steroid treatment

Primary outcomes:
measure: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
timeFrame: 3 minutes
measure: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
timeFrame: 5 minutes
measure: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6
timeFrame: 7 minutes
measure: Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
timeFrame: 7 minutes
measure: Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
timeFrame: 15 minutes
measure: Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01227226: Tear Osmolarity Over Time With Artificial Tears
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye
Keywords: Dry eye
Lead sponsor: Hom, Milton M., OD, FAAO
Sponsor class: INDIV
Collaborators: name: Allergan
First posted: 2010-10-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The effect of artificial tears on tear osmolarity

Detailed description: Tear osmolarity measures the amount of solutes in the human tear film. The higher the reading, the more likely the patient has dry eyes. Some say it has "potential to be the gold standard" of dry eye testing. The investigators study the tear osmolarity at different time points after instillation of artificial tears.

Eligibility criteria: Inclusion Criteria:

Between the ages of 18 and over inclusive. Males or females Any race or ethnic background Patient is in generally good \& stable overall health. Patient likely to comply with study guidelines \& study visits. Informed consent signed. Subjective evaluation of symptom of dryness (SESoD): Score 2 (Mild)

-

Exclusion Criteria:

Corneal refractive surgery within 6 months of this study. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Corneal staining Grade 3 or higher No Restasis for past 3 months Discontinue topical medications for at least 1 week

Primary outcomes:
measure: Tear osmolarity
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Milton M. Hom, OD, FAAO.
state: California
Study officials:
affiliation: Private Practice
name: Milton M Hom, OD FAAO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06537726: Breath Analysis for the Detection of Invasive Fungal Infections
Official title: Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leukemia
Leukemia, Myeloid
Leukemia, Lymphoblastic
Neutropenia
Chemotherapy-induced Neutropenia
Invasive Fungal Infections
Invasive Pulmonary Aspergillosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute leukemia that are undergoing chemotherapy at the Department of Medical Oncology and Haematology at the University Hospital Zurich

Brief summary: Patients with leukemia and concomitant neutropenia are at high risk of developing invasive fungal infections (IFI) that are associated with high morbidity and mortality. As these patients typically have severe thrombocytopenia, direct diagnostic sampling with invasive procedures is often not possible due to the high peri-interventional risk. Therefore, the presumptive diagnosis of IFI is primarily based on compatible lung findings on computed tomography and serologic detection of fungal cell wall components, which, however, have limited sensitivity and specificity.

With the present study, the investigators aim to determine a set of specific volatile biomarkers in leukemia patients with proven or probable IFI using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute leukemia
* Planned chemotherapy with a duration of hospitalisation of 2 weeks or longer
* Neutropenia (\<500/µl) present at inclusion or planned chemotherapy with expected neutropenia (\<500/µl) for more than 7 days

Exclusion Criteria:

* Unable to follow instructions for breath analysis
* Anatomic abnormalities precluding the use of a mouthpiece for breath analysis

Primary outcomes:
measure: Novel biomarker (m/z value) for IFI by SESI-HRMS
timeFrame: through study completion, on average after 3 weeks
Secondary outcomes:
measure: Specificity and sensitivity of this novel biomarker
timeFrame: through study completion, on average after 3 weeks
measure: Anticipation of IFI
timeFrame: through study completion, on average after 3 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: University of Zurich
name: Jeremy Deuel, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04472026: AIM1: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Official title: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodules
Thyroid Cancer
Keywords: thyroid nodules
shared decision making
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-07-15
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: There is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate when deciding the next step in management for a thyroid nodule. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer. This entry (Aim 1) has an associated study (Aim 2) registered under NCT04463719


Eligibility criteria: Inclusion Criteria:

* Adults \>18 years old presenting for evaluation of a thyroid nodule

Exclusion Criteria:

* Patients with hyperthyroidism
* Patients with previous biopsy of the nodule of interest
* Pregnant patients
* Prisoners

Primary outcomes:
measure: Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
timeFrame: Up to the time the post visit interview was completed (on average 1 weeks after the clinical visit for patients and 1 month after completion of 3 visit using the tool for clinicians)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: University of Florida
name: Naykky Singh Ospina
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02601326: Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse
Official title: Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complete Rectal Prolapse
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications

Detailed description: A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications.

Follow up is scheduled for 18 months to evaluate recurrence, continence state and complications

Eligibility criteria: Inclusion Criteria:

* patients with complete rectal prolapse

Exclusion Criteria:

* patients who underwent previous surgery for complete rectal prolapse
* patients unfit for surgery
* patients with associated colorectal diseases or pathology

Primary outcomes:
measure: Recurrence of the condition
timeFrame: 18 month
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh Emile, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05257226: Both Short- and Long-term Outcome Differences According to Patient Frailty
Official title: Both Short- and Long-term Outcome Differences According to Patient Frailty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: surgically treated patients for gastroenterological diseases

Brief summary: The evaluation for cancer treatment successful has been used by overall survival rate and/or postoperative complications, especially surgical area. Now postoperative QOL has been more importantly required. Therefore this study was conduced to investigate the association between postoperative outcomes and patients frailty.


Eligibility criteria: Inclusion Criteria:

* surgical patients

Exclusion Criteria:

* a body weight loss of \>10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease

Primary outcomes:
measure: postoperative short-term outcomes
timeFrame: up to 24 weeks
Secondary outcomes:
measure: postoperative long-term outcomes
timeFrame: 5 year
Other outcomes:
Locations:
city: Kochi
country: Japan
facility: Takehiro Okabayashi
Study officials:
References:
Clinical trial NCT00737126: The Effect of Folic Acid Administration in the Progression of Microalbuminuria
Official title: Folic Acid Administration Reduces the Progression of Microalbuminuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathies
Hyperhomocysteinemia
Keywords: Diabetic nephropathies
Hyperhomocysteinemia
Folic acid
Endothelial dysfunction
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
Collaborators: name: Laboratorios Valdecasas S.A.
First posted: 2008-08-18
Enrollment: 40
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 development of diabetic nephropathy has been linked to several genetic polymorphisms, including those related with homocysteine metabolism such as the methylenetetrahydrofolate reductase (MTHFR)and the cystathionine-beta-synthase genes. Such alterations are associated with hyperhomocysteinemia, which is a known independent risk factor for the development of endothelial dysfunction and cardiovascular disease.

In the Mexican population there is a high prevalence of the C677T MTHFR mutation. The investigators performed this study to evaluate the prevalence of this polymorphism in type 2 diabetic patients with diabetic nephropathy compared with type 2 diabetic patients without nephropathy, besides evaluating the relationship of hyperhomocysteinemia with endothelial dysfunction and microalbuminuria before and after the administration of folic acid. We proposed that the endothelial dysfunction caused by the hyperhomocysteinemia could be reversed after the administration of folic acid.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus patients with 5 to 15 years of diagnosis
* Microalbuminuria (defined as a urinary albumin/creatinine ratio between 30 and 300 mg/g)
* A1c less than 9% in the last year

Exclusion Criteria:

* Acute diabetic complications
* A1c greater than 9% in the last year
* Acute infectious process
* Hepatic disease
* Thyroid disease

Primary outcomes:
measure: Change in albumin excretion rate
timeFrame: Four months
Secondary outcomes:
measure: Change in serum homocysteine, thrombomodulin and von Willebrand factor.
timeFrame: Four months.
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario "José E. González"
state: Nuevo León
Study officials:
affiliation: Departamento de Endocrinología del Hospital Universitario "José E. González"
name: Fernando J Lavalle, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02644226: Laryngeal Mask Airway (LMA) Complication in Children
Official title: Retrospective Investigation of Perioperative Upper Airway Complications After Anesthesia Using Supraglottic Airway Devices in Children: Comparison of Desflurane and Sevoflurane
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngeal Mask Airway
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 3528
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane or desflurane as maintenance agents in Seoul National University Bundang Hospital between June 2013 and June 2015.

Brief summary: Desflurane is known to be the most pungent of the currently used volatile anesthetics. The investigators tried to find out if desflurane increases the incidence of perioperative upper airway complications in infants and children undergoing general anesthesia using supraglottic airways compared to sevoflurane.

Detailed description: The investigators retrospectively reviewed and analyzed the electrical medical records of consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane or desflurane as maintenance agents.

Eligibility criteria: Inclusion Criteria:

* Children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane or desflurane as maintenance agents

Exclusion Criteria:

* Tracheal intubation

Primary outcomes:
measure: Occurrence of Laryngospasm
timeFrame: intraoperative
measure: Occurrence of Cough
timeFrame: intraoperative
measure: Occurrence of desaturation
timeFrame: intraoperative
Secondary outcomes:
measure: Occurrence of Laryngospasm
timeFrame: through study completion, an average of 1 day
measure: Occurrence of desaturation
timeFrame: through study completion, an average of 1 day
measure: Occurrence of Cough
timeFrame: through study completion, an average of 1 day
Other outcomes:
Locations:
Study officials:
References: