louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05334316: Individualizing Corticosteroid Use in Pneumonia
Official title: Individualizing Corticosteroid Use in Pneumonia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pneumonia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 24
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: In this study, researchers propose a unique (individualized) approach to steroid treatment seeking to give the right dose of steroid to the right patient and at the right time. This study seeks to compare usual care to an individualized steroid dosing strategy by testing a marker of inflammation in the blood called C- reactive protein (CRP). The overall goal is to reduce an individual's exposure to steroids and the risk of potential side effects thereby increasing the potential benefit of using steroids to control inflammation in pneumonia.


Eligibility criteria: Inclusion Criteria:

* Hospitalized adult (≥ 18 years) patients.
* Community acquired pneumonia.

Exclusion Criteria:

* Contraindications or unwillingness to use corticosteroids by patient or provider.
* History of adrenal insufficiency, septic shock, or another absolute indication for steroid use.
* Suspected pulmonary vasculitis or other autoimmune pulmonary disorder.
* Positive pregnancy test
* Comfort care.

Primary outcomes:
measure: Adherence to individual treatment rule and CRP-guided corticosteroid treatment
timeFrame: First 5 days of hospitalization or until hospital discharge (whichever is sooner)
Secondary outcomes:
measure: In-hospital Disease Progression
timeFrame: First 5 days of hospitalization or until hospital discharge (whichever is sooner)
measure: Need for Advanced Respiratory Support
timeFrame: First 5 days of hospitalization or until hospital discharge (whichever is sooner)
measure: Advanced respiratory support free days
timeFrame: First 5 days of hospitalization or until hospital discharge (whichever is sooner)
measure: ICU and hospital free days
timeFrame: First 5 days of hospitalization or until hospital discharge (whichever is sooner)
measure: Mortality
timeFrame: First 5 days of hospitalization or until hospital discharge (whichever is sooner)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yewande Odeyemi, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05723016: Anti-Müllerian Hormone and Embryo Aneuploidy
Official title: Serum Anti-Müllerian Hormone Levels and Its Association With Aneuploidy Rates in Human Blastocysts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Aneuploidy
Keywords: AMH
IVF
Aneuploidy
PGT-a
anti-mullerian hormone
oocyte quality
Lead sponsor: Clinica de la Mujer Medicina Reproductiva, Chile
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent a first IVF cycle with PGT-A at the blastocyst stage

Brief summary: The goal of this observational study is to determine is there an association between the rates of aneuploidy and the different ranges of serum Antimullerian hormone (AMH) levels.

Retrospective, single-centre study of patients undergoing IVF and preimplantation genetic testing with aneuploidy at the blastocyst stage between January 2018 and December 2022.


Eligibility criteria: Inclusion Criteria:

* All started cycles planned to be followed by preimplantation genetic testing for aneuploidies (PGT-A). PGT-A is proposed to the couples for the following reasons: advanced maternal age, recurrent miscarriage, repeated implantation failure or severe male infertility factor; it is also offered to all patients with a good prognosis who desired information regarding the ploidy status of their embryos.

Exclusion Criteria:

* Data from oocyte donation cycles

Primary outcomes:
measure: Aneuplody rate
timeFrame: 4 years
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 4 years
measure: Miscarriage rate
timeFrame: 4 years
Other outcomes:
Locations:
city: Viña Del Mar
country: Chile
facility: Clinica de la Mujer Medicina Reproductiva
state: Valparaíso
Study officials:
References:
Clinical trial NCT00783016: Effect of Pain Control on the Diagnosis of Acute Appendicitis on the Diagnostic Accuracy of General Surgeon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Appendicitis
Keywords: appendicitis
diagnosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 234
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The pain control in surgical abdomen has been in debate in masking the correct diagnosis. We would like to investigate the effect of pain control on the diagnostic accuracy of surgeon in suspicious appendicitis patients.

We would give morphine or placebo to the patients suspected of appendicitis randomly and in double-blinded manner, and then surgeons would exam the patient and give the impression for the possibility of the appendicitis(grading 1 to 4).

With this grading, we compare these impression between two groups.


Eligibility criteria: Inclusion Criteria:

* the patients suspected of acute appendicitis over 15 years

Exclusion Criteria:

* less than 15 years
* pregnant
* allergic to morphine
* systolic blood pressure\<100mmHg
* received pain killer prior to ED visit
* do not consent

Primary outcomes:
measure: AUC of ROC of the impression of diagnosis for the appendicitis by surgeon
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital, Emergency room
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT04159116: Prevention and Treatment of Laryngospasm and Hypoxemia Based on Risk Factors in Adult Outpatients Undergoing EGD
Official title: Development of a Protocol for Prevention and Treatment of Laryngospasm and Other Causes of Hypoxemia Based on Identified Risk Factors in Adult Outpatients Undergoing Esophagogastroduodenoscopy (EGD) Under Monitored Anesthesia Care (MAC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngospasm
Hypoxemia
Lead sponsor: Envision Healthcare Scientific Intelligence, Inc.
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to identify patient and provider-chosen factors that put patients at risk for the development of hypoxemia (oxygen saturation \< 90% for 5 seconds) during endoscopy and to use this knowledge to develop a treatment protocol for specific causes of hypoxemia in adult esophagogastroduodenoscopy outpatients.


Eligibility criteria: Inclusion Criteria:

* Over the age of 18 years
* English speaking
* Mentally competent to sign their own consent for treatment

Exclusion Criteria:

* Poor incisor teeth stability
* Anticipated procedure of greater than 30 minutes
* History of facial or oral surgery and a baseline oxygen saturation of less than 95% on room air

Primary outcomes:
measure: Incidence of laryngospasm during EGDs
timeFrame: 2 hours
measure: Identify risk factors for the development of hypoxemia during EGD
timeFrame: 2 hours
Secondary outcomes:
measure: Incidence of copious secretions, choking, desaturation, and shortened or aborted procedures
timeFrame: 2 hours
measure: Identify the various causes of hypoxemia during EGD
timeFrame: 2 hours
Other outcomes:
Locations:
city: Moon
country: United States
facility: Three Rivers Endoscopy
state: Pennsylvania
Study officials:
affiliation: Envision Healthcare
name: Suzanne Morrison, DNP, CRNA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03281616: Lifestyle in Turkish-Background Diabetics
Official title: Lifestyle Interventions in Turkish-background Patients With Metabolic Syndrome and Diabetes in Germany
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Life-style interventions are indicated in patients with metabolic syndrome and/or type 2 diabetes. However, cultural differences are substantial confounders to not only compliance, but also whether or not the interventions are offered in the first place. In Germany, the large Turkish-background minority has a particularly high incidence of type 2 diabetes, but there is no recorded evidence of a life-style intervention in this patient group.

Objective: The investigators tested the body weight-reducing effect of a 30% calorie-reduced diet, adjusted to individual eating habits and preferences regarding quality and resources of food in a Turkish-background cohort.

Detailed description: The investigators conducted a prospective, randomized, two-arm parallel study. In both arms, patients were instructed in a 12-week diet that was reduced by in caloric content by at least 30% based on calorimetric measurements of 24 h resting energy expenditure and estimated additional expenditures by diet- and activity-induced thermogenesis. Before and after the diet, anthropometric measures and various MetS-associated blood parameters were determined.

The subjects were not instructed in an exercise program. However, the subjects were advised on the value of increased physical activity. For additional motivation, effects were tested by an activity monitor. Therefore, in one of the arms, 24 hour locomotor activity and energy expenditure were determined by means of the SenseWear® MF armband (Body Media Inc., AliphCom dba Jawbone®, Pittsburgh, PA, U.S.A.). This device detects activity contest using accelerometers and assesses daily energy expenditure. For allocation of the subjects, a computer-generated list of random numbers was used. The randomization sequence was created using SPSS 18 (SPSS, Inc., Chicago, IL, USA) statistical software and subjects were assigned to be tested or not for locomotor activity with a 1:1 allocation using random block sizes of 2, 4, and 6.

Eligibility criteria: Inclusion Criteria:

* Age 30 - 65 years
* BMI 30 - 40 kg/m2
* non-Insulin dependent diabetes

Exclusion Criteria:

* Pregnancy
* more than 3 anti-diabetic drugs

Primary outcomes:
measure: Body weight reduction
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood glucose
timeFrame: 12 weeks
measure: Blood HbA1c
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05443516: Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus
Official title: Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus. Recherche de Biomarqueurs de l'activité de la Maladie Chez Des Patients Atteints de Lupus érythémateux disséminé.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lupus Nephritis
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Incident or Flare biopsy-proven proliferative or membranous LN diagnosis

Brief summary: The aim of this research project is to better understand the origin and clinical significance of two lupus-specific "genetic signatures" (IFN signature and plasma cell signature) in patient subgroups with well-defined clinical characteristics. Our aim is to correlate these genetic signatures with cell activation profiles and the production of specific cytokines in different populations from whole blood and in short-term cultures of these circulating cells.

Detailed description: The aim of the experiment is, on the one hand, to identify and study the different cell populations from whole blood by flow cytometry and, on the other hand, to assay different cytokines in blood and urine samples from diseased (SLE) and control subjects (with non-inflammatory rheumatic diseases) in order to highlight and correlate the presence of biomarkers to disease activity or to a clinical manifestation of the disease.

In vitro studies will also be carried out on short-term cultures of PBMCs (Peripheral Blood Mononuclear Cells).

Eligibility criteria: Inclusion Criteria:

* Fulfilment of the EULAR/ACR classification criteria of SLE.
* 18 years of age or above.
* Incident or Flare biopsy-proven proliferative or membranous LN

Exclusion Criteria:

* Antiphospholipid syndrome nephropathy (APSN).
* Pregnancy at baseline (pregnancy during follow-up will not lead to exclusion).
* Anticipated non-adherence to therapy.
* Medical conditions interfering with outcome evaluations.
* Inability to read and/or sign the informed consent form.

Primary outcomes:
measure: Biomarker analysis of lupus nephritis activity - whole blood cell populations
timeFrame: baseline
measure: Biomarker analysis of lupus nephritis activity - blood cytokines
timeFrame: baseline
measure: Biomarker analysis of lupus nephritis activity - urine cytokines
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Frédéric Houssiau, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06950216: IONM During Radical Prostatectomy
Official title: Intraoperative Neuromonitoring During Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Intraoperative neuromonitoring
Urinary incontinence
Erectile dysfunction
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: At present, the preferred treatment for patients with prostate cancer is still radical prostatectomy. Postoperative patients often face some complications, the most common complications include urinary incontinence and erectile dysfunction. Urinary incontinence is caused by intraoperative injury of urinary control nerves or muscles. Erectile dysfunction is related to intraoperative injury of nerves that control erection. Therefore, intraoperative nerve preservation is a key measure to reduce postoperative complications, especially to prevent erectile dysfunction. This study intends to improve the nerve-sparing radical prostatectomy by monitoring the nerve during radical prostatectomy, locating the cavernous nerve and other related nerves, in order to reduce the incidence of postoperative complications such as erectile dysfunction.


Eligibility criteria: Inclusion Criteria:

- 1: Prostate cancer patients undergoing surgical treatment in our Hospital 2: Understand the content of this study, actively provide complete and true medical history and examination data, and be willing to cooperate with postoperative interviewers.

3: Voluntarily participate in the study and sign the treatment document within the ethical framework.

Exclusion Criteria:

* 1: Histopathology showed that the patient did not have prostate cancer 2: Use a cardiac pacemaker or other electromechanical prosthesis device 3: Suffering from a serious neurological disease, mental illness or other illness that may be life-threatening within two years

Primary outcomes:
measure: IIEF-5
timeFrame: 1,3,6 and 12 months after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Fourth Affiliated Hospital Zhejiang University School of Medicine
name: Yichun Zheng, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01007916: Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-11-05
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.


Eligibility criteria: Inclusion Criteria:

* Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
* Wears lenses at least 5 days per week and at least 12 hours per day.
* Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
* Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
* Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
* Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
* Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Currently sleeping in contact lenses for more than 6 consecutive nights.
* Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Comfort Upon Insertion
timeFrame: 4 weeks of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03700216: Construction of the Evaluation System of Limb Blood Circulation After Fracture of Limbs in Children
Official title: Construction of the Evaluation System of Limb Blood Circulation After Fracture of Limbs in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Circulation Disorder
Keywords: limb Fracture
limb blood circulation
early-warning model
Children
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 201
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with limb fractures diagnosed by X-ray film

Brief summary: This study is aimed to construct a multi-parameter early-warning model based on usage of mannitol, using multi-factor regression and combining with previous clinical experience, literature, expert opinions. The investigators will evaluate the predictive value of the model for mannitol usage and gypsum cutting open through cohort study verification.

Detailed description: The investigator will retrospect the data of operative patients with limb fracture in Pediatric Orthopedics Unit of Shanghai Xinhua Hospital in 2016 to collect the basic information about this kind of patient, including age, gender, kind of fracture, temperature and color of skin, swell, artery pulse, laboratory test indicators, method of fixation, and the usage of mannitol. Then, combining the professionals' suggestions, the investigator will use multi-factor regression to identify the independent risk factors of blood circulation disorder. According to the independent risk factors, the early-warning model of blood circulation disorder will be built, and the rating scale as well. Finally, the critical value of blood circulation disorder after limb fracture will be set by receiver operating characteristic curve.

Eligibility criteria: Inclusion Criteria:

* Age from 0 to 14 years;
* Children with limb fractures diagnosed by X-ray film;
* The surgical method is open reduction and wire-pin fixation or steel plate internal fixation;
* Children with postoperative plaster fixation;
* Children whose guardian signed informed written consent.

Exclusion Criteria:

* Children with nerve damage which have caused dysfunction such as sensory and motor;
* Children with fracture in other parts or organic diseases.

Primary outcomes:
measure: Number of participants with Limb Blood circulation disorder
timeFrame: Within 1 year after mannitol treatment
Secondary outcomes:
measure: Number of adverse events
timeFrame: Within 1 year after mannitol treatment
measure: Blood oxygen saturation at the end of extremities
timeFrame: Within 1 year after mannitol treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Ting Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01264016: Performance of a New Glucose Meter System
Official title: Performance of the TATSU/Tradewind Blood Glucose Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the performance and acceptability of a new blood glucose monitoring system, which includes meter and sensor strip.


Eligibility criteria: Inclusion Criteria:

* Type 1 or 2 diabetes
* Age 18 years or older
* Routinely performs blood glucose self testing at home, at least once per day
* Able to speak, read, and understand English.
* Is willing to complete all study procedures

Exclusion Criteria:

* Currently pregnant
* Hemophilia or any other bleeding disorder
* Taking prescription anticoagulants or has clotting problems that may prolong bleeding. Taking aspirin daily is not excluded
* Subject employee of competitive medical device company
* Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study

Primary outcomes:
measure: Percent of Capillary Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
timeFrame: 2 hours
measure: Percent of Venous Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
timeFrame: 2 hours
Secondary outcomes:
measure: Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)
timeFrame: 2 hours
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
Study officials:
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References: