louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05010746: TVMR With the Innovalve System Trial - Pilot Study in Italy
Official title: TVMR With the Innovalve System Trial - Pilot Study in Italy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2021-08-18
Enrollment: 4
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: Study to evaluate the safety and performance of the Innovalve mitral valve replacement system


Eligibility criteria: Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable
* EF \<30%

Primary outcomes:
measure: Absence of implant or delivery related serious adverse events at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Technical Success
timeFrame: Procedure
measure: Procedural Success
timeFrame: 30 days
measure: Device Success
timeFrame: 30 days, 3, 6, 12 months and annually up to 5 years
measure: Patient Success
timeFrame: 1 year
measure: Improvement in NYHA Class
timeFrame: 30 days, 3, 6, 12 months and annually up to 5 years
measure: Increase in 6MWD
timeFrame: from baseline to 30 days, 3, 6, 12 months and annually up to 5 years
measure: Quality of life improvement (KCCQ-12)
timeFrame: from baseline to 30 days, 3, 6, 12 months and annually up to 5 years
measure: Reduction in MR grade
timeFrame: from baseline to 30 days, 3, 6, 12 months and annually up to 5 years
measure: Atrial septal defects requiring closure
timeFrame: 30 days, 3, 6, 12 months and annually up to 5 years
measure: Change in Montreal Cognitive Assessment (MoCa)
timeFrame: Discharge and 30 days
measure: Composite of MVARC criteria
timeFrame: 30 days, 3, 6, 12 months and annually up to 5 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Humanitas
Study officials:
affiliation: Humanitas IRCCS
name: Antonio Colombo, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02968446: Effect of Vitamin D After Application With Valchlor
Official title: The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical Application With Valchlor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Skin Irritation
Keywords: Valchlor
Vitamin D
Healthy Volunteer
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2016-11-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to evaluate the effects of an oral Vitamin D on the body's immune system.

An interest has been growing because studies have shown that Vitamin D may reduce inflammation and harmful effects in the body, however, the best dose for Vitamin D is still unknown.

Inflammation is the body's physical response to infection, injury, or long term disease. Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the body. This study will look at product use, testing skin irritation in healthy volunteers and seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could one day help doctors prescribe Vitamin D to patients with long term disease to relieve their symptoms.

Detailed description: Primary Endpoint To determine the effect of a topical application of Valchlor on human subjects at the clinically approved dose.

Secondary Endpoint To establish the efficacy of cholecalciferol (vitamin D3) in reducing skin irritation 48 hours after topical application of Valchlor.

Eligibility criteria: Inclusion Criteria:

* Must be in general good health
* Fitzpatrick Skin Type I-VI
* Able to list all current medications and medical conditions
* Capable of giving informed consent

Exclusion Criteria:

* Women who are pregnant, nursing, or who may become pregnant in the next 3 months
* Participants taking illegal drugs
* Currently taking ketoconazole, colestipol, cholestyramine, phenobarbitol, phenytoin, or mineral oil
* Currently consuming 800IU or more of vitamin D a day
* Subjects whose BMI are \> 40

Primary outcomes:
measure: Change in skin erythema
timeFrame: Up to 1 week after mechloroethamine exposure
Secondary outcomes:
measure: Change in skin thickness
timeFrame: Up to 1 week after mechloroethamine exposure
measure: Change in TNF-alpha expression
timeFrame: Up to 120 hours after mechloroethamine exposure
measure: Change in iNOS expression
timeFrame: Up to 120 hours after mechloroethamine exposure
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: Northwestern University
name: Kurt Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02891746: Maternal and Neonatal Microbiome
Official title: The Neonatal Microbiome and Its Influence on the Post-partum Period
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Microbiota
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Bar-Ilan University, Israel
First posted: 2016-09-07
Enrollment: 0
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 premature infants ≤ 34 weeks of gestation admitted to the Neonatal Intensive Care Unit and their mothers.

The control group :

100 neonates ≥ 37 weeks gestation of which 50 were delivered vaginally and 50 by Caesarean section and their mothers.

Brief summary: The aim of the study is to characterize and monitor the microbiome of premature infants born in the investigators facility until discharge from the NICU. The investigators will also examine the relationship between mode of delivery and the microbiome of the infant, while exploring various possible factors that may affect it. In addition, the investigators will compare the microbiome of premature infants to the microbiome of term babies born at the same time in the same facility.


Eligibility criteria: Inclusion Criteria:

* Premature infants ≤ 34 weeks of gestation admitted to the Neonatal Intensive Care Unit at Hadassah University Hospital, Mount Scopus and their mothers.

The control group:

* Neonates ≥ 37 weeks gestation of which 50 were delivered vaginally and 50 by Caesarean section at Hadassah University Hospital, Mount Scopus and their mothers.

Exclusion Criteria:

* Neonates with congenital anomalies or metabolic conditions.

Primary outcomes:
measure: Definition the flora comprising the microbiome of premature and term babies
timeFrame: birth
Secondary outcomes:
measure: Difference in the microbiome of the infants born vaginally and via caesarian section
timeFrame: birth
measure: Change in the flora that constitutes the microbiome of premature babies
timeFrame: birth until adjusted age of 40 weeks gestation
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT05985512: Subtyping of Insomnia Disorders Based on Multidimensional Features
Official title: A Research on the Typing of Insomnia Disorder Based on Multidimensional Features
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia Disorder
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Based on real world and focusing on patients with chronic sleep disorders, this study conducts a data-driven subtyping research on the clinical symptoms, polysomnography, near-infrared scanning, molecular genetics, and other characteristics of chronic insomnia disorders. It constructs a multimodal therapeutic outcome prediction model, providing a basis for personalized interventions for chronic insomnia disorder.


Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 65 years, regardless of gender;
2. Currently meeting the diagnostic criteria for insomnia disorder according to the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
3. Pittsburgh Sleep Quality Index (PSQI) total score ≥ 10;
4. Sufficient level of education and comprehension to complete the required examinations and assessments for this study;
5. Voluntarily participating in this research and signing the informed consent form.

Exclusion Criteria:

1. Currently diagnosed with other sleep disorders (sleep-related breathing disorders, periodic limb movement disorder, parasomnias, central disorders of hypersomnolence, circadian rhythm sleep-wake disorders, etc.);
2. Currently diagnosed with organic brain diseases (epilepsy, cerebrovascular disease, etc.) or other organic diseases;
3. Patients with a history of or currently diagnosed with bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stressor-related disorders, dissociative disorders, or eating disorders;
4. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
5. Insomnia caused by alcohol or substance abuse;
6. High suicide risk, with HAMD-17 suicide factor score \> 2;
7. Inability to cooperate with near-infrared examinations and polysomnography due to physical conditions such as head injury, etc.

Primary outcomes:
measure: polysomnography
timeFrame: the end of the eighth week
measure: PSQI
timeFrame: the end of the 24th, 36th, 48th week
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Chengmei YUAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07011212: In Search of the Correct Diagnosis of Beta-lactam Allergy: From the Validation of a Risk Stratification Tool to Accurate Endotyping
Official title: In Search of the Correct Diagnosis of Beta-lactam Allergy: From the Validation of a Risk Stratification Tool to Accurate Endotyping
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Drug Allergy
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 332
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: If there are other parties who are masked in the clinical trial besides those listed above, use this space to describe those parties.
Primary purpose: TREATMENT

Brief summary: Testing a clinical decision tool (BL-Predictor)


Eligibility criteria: Inclusion Criteria:

* signed informed consnet

Exclusion Criteria:

* Use of immunomodulators, antihistamines and corticosteroids

Primary outcomes:
measure: The main goal of this project is to test a cliniacl decision toll to stratify BL allergic pataients in low and mediaum- anf high-risk
timeFrame: April 2029- june 2027
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03130946: Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes
Official title: Comparison of the Accuracy and Safety of Biopsy in Suspicious Axillary Lymph Nodes With a Crypo-assisted Stick Freeze Biopsy Device or Fine Needle Aspiration
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Breast Neoplasms
Keywords: breast neoplasms
Ultrasonography, Interventional
Biopsy, Large-Core Needle
Biopsy, Fine-Needle
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm, prospective, open label study
Primary purpose: DIAGNOSTIC

Brief summary: Axillary lymph node status is a vital prognostic factor in breast cancer patients and provides crucial information for making treatment decisions. Ultrasound test with subsequent fine needle aspiration (FNA) biopsy in nodes with suspicious features remains the standard of axillary lymph node workup. Insufficient sampling and limited diagnostic accuracy of cytological test compromise the outcome the preoperative lymph node staging strategy especially in patients with intermediate suspicious nodes. This prospective study is to compare the performance of a crpo-assisted core biopsy with FNA.

Detailed description: This prospective study was planned to evaluate the superiority of a core needle biopsy device with a special cryo-assisted rotational design (Cassi II, USA) compared with FNA for biopsy of intermediately suspicious lymph nodes. Eligible patients would be randomized to one of two arms by 1:2 : Core with FNA or FNA alone. The diagnostic accuracy and adverse outcome of core and FNA would be compared.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed invasive breast cancer.
* With axillary lymph node with thickened cortex.
* Planned for sentinel lymph node biopsy or axillary clearance.

Exclusion Criteria:

* Nodes ultrasonographically normal.
* Nodes with hilar displacement .
* Palpable matted nodes.

Primary outcomes:
measure: Sensitivity of biopsy
timeFrame: Immediate after pathological lymph node stage is available
Secondary outcomes:
measure: Specificity
timeFrame: Immediate after pathological lymph node stage is available.
measure: Sample adequency
timeFrame: Immediate after biopsy specimen is evaluated by pathologists.
measure: Adverse effect of surgery
timeFrame: 4 weeks after surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Shu Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05473546: Diarrhea and Stipsis in Critically Ill Patients (NUTRITI)
Official title: Gastrointestinal Complications of Artificial Nutrition in ICU: a Prospective Observational Study (NUTRITI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Nutritional and Metabolic Disease
Nutritional Deficiency
ICU Acquired Weakness
Enteral Feeding Intolerance
Diarrhea
Constipation
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ADULTS ICU CRITICALLY ILL PATIENTS REQUIRING ICU ADMISSION DUE TO ACUTE ILLNESS WITH ANTICIPATED ICU STAY \> 72 HOURS AND NEEDING ARTIFICIAL NUTRITION

Brief summary: This study prospectively observed the complications intended as diarrhea or sti-sis that critically ill patients developed within 7 days after ICU admission.

In addition, secondary aims investigated through bioimpedenziometry the loss of lean body mass and changes in phase angle during the same period of ICU stay.


Eligibility criteria: Inclusion Criteria:

* ICU ANTICIPATED LENGTH OF STAY \> 72 HOURS
* AGE \> 18 YEARS
* NEED FOR ARTIFICIAL NUTRITION

Exclusion Criteria:

* AGE \< 18 YEARS
* ICU ANTICIPATED LENGTH OF STAY \< 72 HOURS
* NO NEED FOR ARTIFICIAL NUTRITION
* BMI\<16 KG/M2

Primary outcomes:
measure: FREQUENCY OF diarrhea WITHIN 72 HOURS AFTER ICU ADMISSION
timeFrame: 7 DAYS
Secondary outcomes:
measure: FREQUENCY OF CONSTIPATION WITHIN 7 DAYS AFTER ICU ADMISSION
timeFrame: 7 DAYS
measure: LOSS OF LEAN BODY MASS AFTER 7 DAYS IN ICU
timeFrame: 7 DAYS
measure: CHANGES IN PHASE ANGLE AFTER 7 DAYS IN ICU
timeFrame: 7 DAYS
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Cristian Deana
Study officials:
affiliation: Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy
name: CRISTIAN DEANA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04506346: Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient
Official title: Risk Prediction of Difficult Tracheal Intubation in Obstructive Sleep Apnea Hypopnea Syndrome Patient (OSAHS) Undergoing Uvulo-palato-pharyngoplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Difficult Intubation
Airway Obstruction
Keywords: airway management
obstructive sleep apnea hypopnea syndrome
risk predictive model
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate or severe obstructive sleep apnea hypopnea syndrome, which means apnea-hypopnea index( AHI) \>15/h and lowest SpO2(LSpO2)\<85% in polysommographic test.

Brief summary: This study evaluates the risk factors for difficult tracheal intubation in in obstructive sleep apnea hypopnea syndrome(OSAHS) patients undergoing uvulo-palato-pharyngoplast(UPPP)

Detailed description: OSAHS patients are high risk group of difficult tracheal intubation. In clinical application, unexpected difficult tracheal intubation is not rare. Difficult airway is a significant problem to these patients and the physicans in terms of mortality and morbidity.

This study collects risk factors as physical examinations（including modified Mallampati grade, neck circumference, lateral clinical craniofacial assessment and body mass index ,BMI）, Stopbang scores, polysommographic parameters (including apnea-hypopnea index, AHI and lowest SpO2, LSpO2), and special radiographic parameters in head and neck region. By using statistics method, predictive model to manage risks would be established.

Eligibility criteria: Inclusion Criteria:

* diagnosed as OSAHS.
* receive UPPP under general anesthesia in Beijing Tsinghua Changgung Hospital
* ASA grade I or II

Exclusion Criteria:

* ASA grade III or above
* had received UPPP
* had fore-teeth loosed
* obstructive sleep apnea hypopnea were caused by hypothyroidism, acromegaly, or vocal cord paralysis.

Primary outcomes:
measure: Difficult Tracheal Intubation
timeFrame: 1min After tracheal intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: YAN SIYI
state: Beijing
Study officials:
affiliation: department of anesthesia
name: Huan Zhang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06011746: Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy
Official title: Efficacy of Adding Ketamine to Levobupivacaine in Paravertebral Block on Acute and Chronic Pain in Thoracotomy: a Randomized Controlled Double-blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ketamine
Levobupivacaine
Paravertebral Block
Acute Pain
Chronic Pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 60
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: To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain in thoracotomy

Detailed description: Several adjuvants have been added to them to enhance the effects of those blocks. Dexamethasone, morphine, dexmedetomidine, clonidine, ketamine, and magnesium sulphate are some of them. results are variable.

Ketamine blocks N-Methyl-D-Aspartate (NMDA) receptors in the spinal cord. It is also considered to influence voltage sensitive Calcium ions channels, opioid receptors, and monoaminergic receptors. Therefore, it is considered overall to affect nociception.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years.
* Both sexes.
* ASA (American Society of Anesthesiology) physical status II-III.
* Scheduled for open thoracotomy.

Exclusion Criteria:

* Contraindications to or failed paravertebral block .
* Body mass index (BMI) \>35 kg/m2.
* The likelihood of postoperative mechanical ventilation.
* Patients with coagulopathy, poorly controlled diabetes mellitus, depression or other psychiatric disorders that required antidepressant drugs, alcohol, or recreational drug addiction.
* Hypersensitivity to ketamine or levobupivacaine.

Primary outcomes:
measure: Time to first analgesia
timeFrame: 24 hour postoperatively
Secondary outcomes:
measure: Total amount of morphine consumption
timeFrame: 24 hour postoperatively
measure: Pain intensity during rest
timeFrame: 48 hour postoperatively
measure: Pain intensity during deep breathing
timeFrame: 48 hour postoperatively
measure: Incidence of chronic pain
timeFrame: three months postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT04666246: Inspiratory Effort in COVID-19
Official title: Inspiratory Effort Assessment in Patients With COVID-19 Pneumonia Undergoing Non Invasive Respiratory Support
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Failure
Covid19
Keywords: Acute respiratory failure
Esophageal pressure
Non invasive respiratory support
COVID-19
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena for acute respiratory failure due to COVID-19 pneumonia and candidate to non invasive respiratory support

Brief summary: This study aims at assessing esophageal pressure in patients with acute respiratory failure due to COVID-19 undergoing non invasive respiratory support.


Eligibility criteria: Inclusion Criteria:

* COVID-19
* Acute respiratory failure undergoing non-invasive respiratory support

Exclusion Criteria:

* Need for immediate endotracheal intubation
* Chronic respiratory diseases

Primary outcomes:
measure: Inspiratory effort quantification
timeFrame: 24 hours from admission
Secondary outcomes:
measure: Non invasive respiratory support failure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Modena
country: Italy
facility: University Hospital of Modena
Study officials:
References: