louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05345574: A Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position
Official title: The Effect of Dexmedetomidine and Remifentanil Infusion on Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Sore Throat
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was performed to compare the effect of dexmedetomidine and remifentanil on the incidence and severity of postoperative sore throat in patients undergoing spinal surgery in the prone position who are at risk of developing postoperative sore throat.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status classification I and II
2. Undergoing lumbar spine surgery in prone position

Exclusion Criteria:

1. Pre-existing sore throat, hoarseness, or upper respiratory tract infection
2. Allergy to the study drugs
3. Anticipated difficult airways
4. More than two attempts at intubation

Primary outcomes:
measure: incidence of postoperative sore throat at rest
timeFrame: 1 hour after surgery
measure: incidence of postoperative sore throat at swallowing
timeFrame: 1 hour after surgery
measure: severity of postoperative sore throat at rest
timeFrame: 1 hour after surgery
measure: severity of postoperative sore throat at swallowing
timeFrame: 1 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Eun kyung Choi
state: Korea (the Republic Of)
Study officials:
References:
Clinical trial NCT00274274: Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes
Official title: Efficacy and Safety of Insulin Aspart in a Fixed or Flexible Supplementary Insulin Therapy Regimen, With or Without Insulin Detemir in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-01-10
Enrollment: 373
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: This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes for more than 6 months
* Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months
* Body Mass Index (BMI) less than or equal to 40 kg/m2
* HbA1c 7.0-11.0%

Exclusion Criteria:

* Treatment with short acting insulin(s) for longer than 10 days
* Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization
* Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months

Primary outcomes:
measure: HbA1c
timeFrame: after 52 weeks
Secondary outcomes:
measure: Blood glucose profiles
measure: Percentage of patients with HbA1c less than 7.0% after 52 weeks
measure: Quality of Life
measure: Frequency of BG measurements
measure: Safety parameters
measure: Duration of education
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02156674: Naglazyme After Allo Transplant for Maroteaux-Lamy Syndrome
Official title: Study of Administration of Intravenous Naglazyme® Following Allogeneic Transplantation for Maroteaux-Lamy Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Maroteaux-Lamy Syndrome
Keywords: Maroteaux-Lamy Syndrome
mucopolysaccharide VI
MPS VI
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: BioMarin Pharmaceutical
First posted: 2014-06-05
Enrollment: 1
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center study in which Naglazyme® will be given weekly for two years in patients with Maroteaux-Lamy syndrome, also known as mucopolysaccharide VI (MPS VI), who have previously been treated with an allogeneic transplant.


Eligibility criteria: Inclusion Criteria:

* Mucopolysaccharidosis type VI (MPS VI, Maroteaux-Lamy syndrome) treated with a prior allogeneic transplant \>2 years previously
* Persons currently receiving Naglazyme may be accepted into the study
* Age \> 2 years
* \>10% engrafted based on most recent testing
* Willing to commit to traveling to the University of Minnesota every 6 months
* Written informed consent with parent/guardian consent for children \< 18 years of age or persons unable to consent with minor assent if appropriate

Exclusion Criteria:

* History of cardiac or pulmonary insufficiency or those requiring continuous supplemental oxygen
* Pregnant or breastfeeding
* Any condition that, in the view of the investigator, places the patient at high risk of poor treatment compliance or of not completing the study

Primary outcomes:
measure: Change in Urinary Glycosaminoglycan (GAG) Excretion
timeFrame: Baseline and 2 years
measure: Change in Distance Traveled
timeFrame: Baseline and 2 years
measure: Change in Neurocognitive Ability
timeFrame: Baseline and 2 years
Secondary outcomes:
measure: Number of Participants With Development of Neutralizing Antibodies to Naglazyme Therapy
timeFrame: 6 months
measure: Number of Participants With Development of Neutralizing Antibodies to Naglazyme Therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Elizabeth Braulin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03927274: Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma
Official title: A Study of Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive World Health Organization (WHO) Grade III or IV (High Grade) Glioma Undergoing Stereotactic Biopsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Glioma of Brain
Keywords: Glioma
Brain Tumor
High Grade Glioma
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 3
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: The purpose of this study is to determine if treatment with Topotecan by an alternative method, delivering topotecan directly into brain tumors, is safe and well tolerated.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of supratentorial WHO Grade III or IV Glioma (High Grade Glioma) that has undergone surgical biopsy or resection followed by adjuvant chemoradiotherapy, that has evidence of recurrence or progression based on imaging studies and a stereotactic biopsy is indicated for confirmation of recurrence/progression.
* 18 years of age or older
* Karnofsky Performance Status 70-100;
* MRI demonstration of a stereotactically accessible enhancing or predominantly non- enhancing mass that does not require resection to relieve clinically significant mass effect;
* Participant understands the procedures and agrees to comply with the study requirements by providing written informed consent
* Adequate organ function as indicated in protocol

Exclusion Criteria:

* Participant is mentally or legally incapacitated at the time of the study;
* Known HIV(+) or has been diagnosed with AIDS
* Participation in another investigational drug study in the prior 4 weeks
* Positive pregnancy test in a female
* Patient, in the opinion of the investigator, is likely to be poorly compliant.
* Diffuse subependymal or Cerebral Spinal Fluid (CSF) disease
* Tumors involving the cerebellum
* Tumor enhancement involving both hemispheres
* Active infection requiring treatment
* Unexplained febrile illness
* Radiation or chemotherapy within 4 weeks of enrollment
* Systemic diseases associated with unacceptable anesthesia or operative risk
* Inability to undergo magnetic resonance imaging (MRI)

Primary outcomes:
measure: Distribution of topotecan in tumor tissue
timeFrame: Treatment day 1
Secondary outcomes:
measure: Number of Adverse Events (AEs) experienced by participants
timeFrame: Up to 48 weeks
measure: Extent of topotecan backflow
timeFrame: Treatment day 1
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Michael Vogelbaum, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06009874: Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI
Official title: Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 80
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: PREVENTION

Brief summary: This study aims to investigate the effect of early administration of DAPA during ischemia and before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection from HF, and renoprotection from AKI in patients with AMI.

Detailed description: DAPA was approved for HF patients, but there is no sufficient data about its efficacy on patients with AMI and if it can protect from the development of HF after AMI.

the investigators aim to investigate the effect of DAPA on patients who presented with AMI when administered as early as possible before pPCI and to be continued for three months after there.

the effect of DAPA on infarct size, cardiac biomarkers will be assessed during the follow-up period

Eligibility criteria: Inclusion Criteria:

1. Patients with ST-elevation myocardial infarction (STEMI).
2. STEMI was defined according to the Fourth Universal Definition of AMI.
3. 18 - 80 years of age.
4. Diabetics or non-diabetics.
5. eGFR \> 45 ml/min/1.73m2.
6. Blood pressure before first drug dosing \>110/70 mmHg.

Exclusion Criteria:

1. Cardiogenic shock.
2. Hypoglycemia.
3. History of diabetic ketoacidosis.
4. Genital and urinary infections.
5. History of AMI.
6. Stent thrombosis.
7. Previous coronary artery bypass surgery.
8. Severe hepatic insufficiency.
9. Advanced cancer patients.
10. Blood pH \< 7.32.
11. Known allergy to SGLT-2 inhibitors.
12. Hemodynamic instability.
13. Females of childbearing potential without adequate contraceptive methods.
14. Patients currently on or have received any SGLT-2 inhibitors.

Primary outcomes:
measure: difference in infarct size
timeFrame: 3 months
measure: difference in NT-proBNP level
timeFrame: 3 months
Secondary outcomes:
measure: Difference in eGFR
timeFrame: 3 months
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Mohammad Soliman
state: Menofia
Study officials:
References:
Clinical trial NCT03810274: 3DV+TPS Software Outlines the Radiotherapy of Nasopharyngeal Carcinoma
Official title: 3DV+TPS Software Outlines the Outline of Radiotherapy for Nasopharyngeal Carcinoma Center Comparison Study Clinical Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiotherapy
Nasopharyngeal Carcinoma
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 7 different grade hospital radiotherapy centers have received radiotherapy for patients with nasopharyngeal carcinoma Case information, based on inclusion and exclusion criteria, a total of 300 cases were screened. Among them, Xinqiao Hospital collected 180 cases, He collected 20 cases in 20 hospitals, totaling 200 cases.

Brief summary: Comparing the accuracy and speed of 3DV+TPS software with imported TPS and domestic TPS to outline the contours of crisis organs, it is proved that 3DV+TPS has superiority compared with domestic TPS, and it has non-inferiority compared with imported TPS, indicating that the software can improve contour sketching accuracy. And speed, reduce the burden on doctors, improve medical efficiency.

Detailed description: Comparing the accuracy and speed difference between 3DV+TPS software and imported TPS and domestic TPS to outline the contours of crisis organs, the selected organs are: bilateral eyeballs, bilateral crystals, bilateral optic nerves, bilateral parotid glands, oral cavity, spinal cord, brainstem, The brain has a total of 12 organs; verify that 3DV+TPS is superior to domestic TPS, and has non-inferiority compared with imported TPS, Ming software can improve the accuracy and speed of contour sketching, reduce the burden on doctors, and improve medical efficiency.

Eligibility criteria: Inclusion Criteria:

1. It is diagnosed as nasopharyngeal carcinoma by histopathological examination, and there is no tumor invasion in the organs that need to be assessed;
2. Age 18-70 years old;
3. There is nasopharynx localization enhanced CT, nasopharynx enhanced MRI.

Exclusion Criteria:

1. Patient information is incomplete; no age, gender, MRI, height, radiotherapy location CT;
2. The organs at risk that need to be assessed are invaded by the tumor;
3. Any reason cannot be combined with the research or the researcher believes that it is not suitable for inclusion in this test.

Primary outcomes:
measure: Sketching accuracy
timeFrame: one year
measure: Sketch speed
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Xinqiao Hospital of Chongqing
Study officials:
References:
Clinical trial NCT01257074: Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis
Official title: A Randomized, Double-Blind, to Compare Non-inferiority Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Labialis
Keywords: Herpes Simplex
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 76
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: Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as treatment for Herpes Labialis in comparison to acyclovir 50mg/g.

Detailed description: Study design:

• Double blinded non-inferiority prospective parallel-group, intend to treat trial.

Study design:

* Experiment duration: 10 days
* 3 visits (days 1,5 and 10)
* Erythema, papule, vesicle, ulcer, crust and healed skin evaluation
* Adverse events evaluation

Eligibility criteria: Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with clinical diagnosis of recurrent herpes labialis and are in the prodromal period (stinging, itching, burning and erythema) at the onset of signs / symptoms in the last 12-24 hours;
3. No history of reaction to topical products;

Exclusion Criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study.)
4. Sunlight over exposure in the last 15 days.
5. Any pathology or past medical condition that can interfere with this protocol.
6. AINH use, hormonal anti-inflammatory, analgesic and immunosuppressive drugs (in the last 30 days and during the study);
7. Patients with immunodeficiency and/or immunosuppressive disease;
8. Sunlight exposure in the last 15 days;
9. Hypersensitivity to components of the formula;
10. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Primary outcomes:
measure: Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation
timeFrame: Day 10
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Day 10
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Flavia Addor
Study officials:
affiliation: Medcin Instituto da Pele Ltda
name: Flavia Addor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04429074: Registrar Performances in MIDP
Official title: Registrar Performance in Laparoscopic Distal Pancreatectomy and Its Effect on Postoperative Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minimally Invasive Distal Pancreatectomy
Keywords: Benign or borderline pathology (non-pancreatic cancer)
laparoscopy
registrar
postoperative outcomes
pancreatectomy
surgery
pancreas
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology

Brief summary: This study aimed to determine whether registrar involvement in minimally invasive distal pancreatectomy (MIDP) was associated with adverse outcomes.

Detailed description: From January 2009 to March 2020, data of all consecutive patients requiring distal pancreatectomy in our public tertiary hospital were prospectively collected and retrospectively analyzed.

Registrars were progressively involved for MIDP since 2009 and their experience was: \< 5 open pancreatic resections, \< 5 MIDP and at least 30 advanced minimally invasive gastrointestinal resections.

Outcome of patients who underwent either distal pancreatectomy by the consultant or registrars were compared.

Our primary outcome was the conversion rate. The secondary outcomes were 90-days postoperative outcomes including CR-POPF defined and classified according to the 2016 ISGPF definition.

Eligibility criteria: Inclusion criteria:

- Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology between 2009-2020

Exclusion criteria:

* open distal pancreatectomy
* minimally invasive distal pancreatectomy for pancreatic cancer
* 20 first consecutive patients operated on by the consultant (learning curve)

Primary outcomes:
measure: open conversion rate
timeFrame: 1 day
Secondary outcomes:
measure: Duration of surgery
timeFrame: 1 day
measure: Intraoperative bloodloss
timeFrame: 1 day
measure: Intraoperative transfusion
timeFrame: 1 day
measure: severe complications Clavien Dindo>3
timeFrame: 90 days postoperative
measure: postoperative complications
timeFrame: 90 days postoperative
measure: clinically relevant postoperative fistula
timeFrame: 90 days postoperative
measure: lenght of hospital stay
timeFrame: 90 days postoperative
measure: readmission rate
timeFrame: 90 days postoperative
measure: reoperation rate
timeFrame: 90 days postoperative
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: REGIS SOUCHE
role: STUDY_DIRECTOR
References:
Clinical trial NCT05680974: Personalized Therapy of Patients Suffering From Rare Genodermatoses
Official title: Gewinnung, Kultur Und Studien Von primären Humanen Zelltypen, Geweben Und Blut für Die Gezielte Behandlung Von Seltenen Hauterkrankungen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rare Diseases
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 25
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 suffering from rare genodermatoses.

Brief summary: Rare skin diseases are generally defined as serious life-threatening, progressive chronic diseases of the skin that occur extremely rarely (i.e., 5 in 10,000 people are affected). More than 80% are hereditary. In most cases, late diagnosis and the lack of therapeutic strategies also contribute to severe disease progression. Therefore, new therapeutic options are urgently needed and with them knowledge of the underlying mechanisms of disease development.

The aim of this project is to better understand disease mechanisms and to identify new pathways and drug targets that will improve patient care or therapy. In order to investigate the mechanisms of disease development, it is necessary to isolate biological material, i.e. blood and affected skin tissue from patients. For this purpose, adults 18 years of age and older with a congenital rare skin disease are included. We take blood and (lesional) skin biopsies from patients to perform immunoprofiling, as well as cell biological studies with the patient's cells. The risk for the patients is low, as only peripheral blood and skin biopsies are taken. Potential risks include bruising and pain as well as infection, postoperative bleeding, wound infection or delayed wound healing, pain, and scarring.

The samples are pseudonymized and stored with the pseudonym only. Cells and skin samples are only preserved with the prior consent of the patient.


Eligibility criteria: Inclusion Criteria:

* age of 18
* rare disease is known or suspected
* patent consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Improvement of disease as assessed by affected body surface area by 50 % upon off-label treatment with approved monoclonal antibody therapies
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Hospital Linz
Study officials:
affiliation: Kepler University Hospital Linz
name: Monika Ettinger, MD PhD
role: STUDY_CHAIR
References: