louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04710381: IMUNOR® Preparation in the Prevention of COVID-19
Official title: Pilot, Monocentric, Phase-IV Clinical Trial Assessing the Clinical Effect of Peroral Immunomodulation Treatment Using the IMUNOR® Preparation in the Prevention of COVID-19 Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covid19
Keywords: Covid19
prevention
pork dialyzed leukocyte extract
immunomodulation
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study treatment (IMUNOR) will be administered to one group of study subjects only.
Primary purpose: PREVENTION

Brief summary: The aim of the study is to achieve prevention of COVID-19 disease in healthcare professionals with the administration of the IMUNOR® preparation, and decreasing the symptoms should the disease appear.

Detailed description: This prospective study is designed to collect data for evaluation of the preventive and therapeutic effect of the IMUNOR® preparation, which is commonly used to treat patients with laboratory or clinical manifestations of immunity disorders. Administration of immunomodulation treatment will be based upon a willing informed consent with the administration of the drug and based upon random selection. The study subjects will receive IMUNOR® preventively; the anticipated preventive effect when using one packing (4 vials) is 6 weeks, and 12 weeks when using two packings. Should any signs of acute illness appear (increased body temperature, cough, loss of smell and taste, etc.), a treatment dose of IMUNOR®, i.e. 1 vial/day (total of 4 vials) will be administered immediately. Monitoring of individual patients will take 6 weeks (1 packing) or 12 weeks (2 packings) from the beginning of IMUNOR® administration. The clinical condition of study subjects will be monitored on a daily basis. At the same time, the possible onset of symptoms will be recorded.

The obtained data will be compared with a control group consisting of patients followed by the Department of Preventive Medicine, University Hospital Ostrava.

Eligibility criteria: Inclusion Criteria:

* Study subjects 18-60 years old
* Ability to cooperate upon the study and to give informed consent

Exclusion Criteria:

* Use of any other immunomodulation treatment one month prior to enrolment and in the course of the study
* Acute disease of the cardiovascular, urogenital, respiratory or nervous system

Primary outcomes:
measure: Prevention of COVID-19 disease
timeFrame: 6 or 12 weeks
measure: Prevention of hospitalisations due to COVID-19
timeFrame: 6 or 12 weeks
Secondary outcomes:
measure: Incidence of sick-leave episodes
timeFrame: 6 or 12 weeks
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Jaromír Bystroň, Ass.Prof.,MD,CSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06202781: Tumor Microenvironment in Gastric Cancer Patients Treated With Combined Immunotherapy and Chemotherapy
Official title: Using Single-cell Sequencing to Explore Tumor Microenvironment in Gastric Cancer Patients Treated With Combined Immunotherapy and Chemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Tumor Microenvironment
Immunotherapy
Chemotherapy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced gastric cancer patients receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab

Brief summary: The goal of this study is to analyze the tumor microenvironment (TME) in gastric cancer patients treated with combined immunotherapy and chemotherapy. The main questions it aims to answer are:

* Provide profiles of TME between pre-treatment and post-treatment to gain insights into the mechanisms of immunotherapy combined with chemotherapy in advanced gastric cancer
* Investigate the crucial factors affecting treatment efficacy by comparing gastric cancer patients with varying treatment responses


Eligibility criteria: Inclusion Criteria:

* Non-bedridden, aged 18 to 70 years old;
* Eastern Cooperative Oncology Group (ECOG) score is 0 to 1;
* Histologically confirmed gastric adenocarcinoma with evaluable lesions based on RECIST 1.1;
* Advanced gastric cancer;
* Ready for receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab

Exclusion Criteria:

* History of other malignant diseases in the last 5 years;
* Prior chemotherapy, radiotherapy or immunotherapy;
* Not receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab.

Primary outcomes:
measure: Single-cell profiling
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02912481: Posterior Tibial Artery Catheterization
Official title: Real-time Ultrasound-guided Arterial Catheterization in Pediatric Patients: Comparison of Success Rate Among the Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Catheterization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 275
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Arterial catheterization in small children is challenging, even for experienced anesthesiologists. For successful arterial catheterization, the arterial diameter, cross-sectional area, and depth from the skin surface are important considerations, especially in pediatric patients. THe investigators examined the posterior tibial artery (PTA) and dorsalis pedis artery (DPA) using ultrasound (US) to find a reasonable alternative arterial cannulation site to the radial artery (RA) in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing general anesthesia needing invasive arterial monitoring

Exclusion Criteria:

* Surgery involving the both hands or foots

Primary outcomes:
measure: first access success rate
timeFrame: immediate after anesthetic induction, maximum 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
References:
Clinical trial NCT02887781: Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France
Official title: Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberous Sclerosis Complex
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with TSC and followed in one of the nephrology centers in the West of France

Brief summary: This study aims to investigate the factors (clinical, care-related and genetic) affecting renal outcome in patients with TSC (Tuberous sclerosis complex)


Eligibility criteria: Inclusion criteria of study participants

* Patient presenting with an isolated angiomyolipoma or
* Patient presenting with tuberous sclerosis complex combined with an angiomyolipoma or
* Patient presenting with tuberous sclerosis complex
* Patient not objecting to the study

Exclusion criteria of study participants

■Patient objecting to the study

Primary outcomes:
measure: Evolution of the renal function estimated by the MDRD GFR
timeFrame: 18 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: University Hospital, Brest
name: Yannick LE MEUR, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03376581: The Utility of Platelet Rich Plasma in Hair Loss
Official title: The Utility of Platelet Rich Plasma in Hair Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Androgenetic Alopecia
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Platelet rich plasma (PRP) is an autologous preparation of human plasma with high concentration of platelets. Platelets release numerous growth factors, which stimulate cell proliferation and differentiation.

The purpose of this research is to investigate the potential of PRP injection for treatment of hair loss. Clinical outcomes will be assessed by noninvasive techniques including dermoscopy, multiphoton microscopy, optical coherence tomography, optical Doppler tomography and multispectral imaging.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Ability to understand and carry out instructions
* Diagnosed with alopecia

Exclusion Criteria:

* Inability to understand and.or carry out instructions
* Pregnant women
* Use of any topical medication (such as minoxidil or any other solution for hair growth), oral medication (finasteride, dutasteride, or antiandrogens), laser therapy, or chemotherapy, within the preceding 4 weeks.
* Personal medical history of bleeding disorders
* Personal medical history of platelet dysfunction syndrome
* Anti-coagulation therapy or nonsteroidal anti-inflammatory drugs in the last 1 week.

Primary outcomes:
measure: Hair density to measure the efficacy of treatment
timeFrame: 6 months
Secondary outcomes:
measure: Hair count (number of hairs/0.65 cm2)
timeFrame: 6 months
measure: Terminal hair density
timeFrame: 6 months
measure: Anagen hair percentage
timeFrame: 6 months
measure: Telogen hair percentage
timeFrame: 6 months
measure: Anagen/telogen ratio
timeFrame: After 3 and 6 months
measure: Changes in hair structure, diameter, and blood flow
timeFrame: 6 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center, Hewitt Hall
state: California
Study officials:
References:
Clinical trial NCT04459481: Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet
Official title: Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-07-07
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Video intubating stylet can be safely and effectively used for nasotracheal intubation, but the optimal bending angle is still unknown. In this study, the optimal bending angle will be determined by comparing the intubation time and success rate of nasotracheal intubation with video intubating stylet at two different bending angles.

Detailed description: intubation will be accomplished at 70 bending angle and 90 degrees bending angle in each group. intubation time, success rate, additional manoeuvres and epistaxis will be recorded and compared.

Eligibility criteria: Inclusion Criteria:

* Patients require nasotracheal intubation

Exclusion Criteria:

* fixed, or limited, neck movement, obstructive sleep apnoea, bilateral nasal obstruction or patients with an abnormal coagulation status

Primary outcomes:
measure: Success rate of nasotracheal intubation
timeFrame: Procedure (From the beginning of intubation to the end of intubation)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: ChineseAMS
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences and Peking Union Medical College
name: Xiaoming Deng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05699681: Correlation of Right Atrial Strain With Pulmonary Hypertension, Right Ventricular Function And Outcome In Pediatric Patients
Official title: Correlation of Right Atrial Strain With Pulmonary Hypertension, Right Ventricular Function And Outcome In Pediatric Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Hypertension
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2023-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As described above.

Brief summary: This observational study aims to assess correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with intraoperatively measured pulmonary artery pressures, other indices of right ventricular function and short term postoperative outcome.


Eligibility criteria: Inclusion Criteria:

* Undergoing elective cardiac surgery for congenital heart disease with left to right shunt
* Prior evidence of pulmonary arterial hypertension on preoperative echocardiography.

Exclusion Criteria:

* Neonates
* Children with history of previous cardiac surgery,
* Hemodynamic instability
* Non-sinus rhythm

Primary outcomes:
measure: Correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with intraoperatively measured systolic pulmonary artery pressures.
timeFrame: For RA strain : after induction of anesthesia, before CPB institution. For pulmonary artery pressures, after induction of anesthesia, before CPB institution, and 10 min after separation from CPB, before sternal closure.
Secondary outcomes:
measure: Correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with other indices of right ventricular function.
timeFrame: For RA strain and RV function : after induction of anesthesia, before CPB institution.
measure: Correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with short term postoperative outcome as defined by duration of mechanical ventilation and duration of ICU stay.
timeFrame: Preoperative (post induction, pre-CPB) RA reservoir, conduit and contractile strain will be correlated with duration of mechanical ventilation, and duration of ICU stay, measured on 30 days post-operative follow up.
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research
Study officials:
References:
Clinical trial NCT02564081: Remote Effects of Lower Limb Stretching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fascia
Randomized Controlled Trial
Stretching
Myofascial
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent research suggests that the skeletal muscles and the fibrous connective tissue form a body-wide network of myofascial chains. A systematic analysis of dissection studies suggests that fascia links at least a variety of muscles to myofascial chains (Wilke et al. 2015). As fascia can modify its stiffness, strain transmission along these meridians is supposable (Norton-Old et al. 2013). Tensile transmission along myofascial chains might contribute to the proper functioning of the movement system. However, despite solid evidence from in vitro studies, scarce data is available concerning the in vivo behavior of the meridians. The present study is conducted to resolve this research deficit and to elucidate whether stretching of the lower limb muscles increases neck mobility. Healthy subjects (n = 3 x 20) participate in the randomized controlled trial. One group performs three 30 s bouts of static stretching for the gastrocnemius and the hamstrings respectively. A control group remains inactive for the same time. Participants of the third group perform 6x30 s bouts of static stretching of the cervical spine in zhe sagittal plane (flexion only). Pre and post intervention as well as 5 min after the intervention, maximal cervical range of motion (ROM) in flexion/extension, lateral flexion and rotation was assessed using an ultrasonic movement analysis system.


Eligibility criteria: Inclusion Criteria:

* healthy participants after subscribing informed consent

Exclusion Criteria:

* severe orthopedic, cardiovascular, neurological, psychiatric or endocrine diseases, not completely healed traumata, drug intake in the past 48 hours, pregnancy and presence of muscle soreness.

Primary outcomes:
measure: Maximal cervical range of motion in flexion/extension
timeFrame: 2 min.
Secondary outcomes:
measure: Maximal cervical range of motion in lateral flexion
timeFrame: 2 min.
measure: Maximal cervical range of motion in rotation
timeFrame: 2 min.
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Department of Sports Medicine, Goethe University Frankfurt/Main
state: Hessen
Study officials:
References:
citation: Wilke J, Krause F, Vogt L, Banzer W. What Is Evidence-Based About Myofascial Chains: A Systematic Review. Arch Phys Med Rehabil. 2016 Mar;97(3):454-61. doi: 10.1016/j.apmr.2015.07.023. Epub 2015 Aug 14.
citation: Norton-Old KJ, Schache AG, Barker PJ, Clark RA, Harrison SM, Briggs CA. Anatomical and mechanical relationship between the proximal attachment of adductor longus and the distal rectus sheath. Clin Anat. 2013 May;26(4):522-30. doi: 10.1002/ca.22116. Epub 2012 Jun 14.
Clinical trial NCT05394181: Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates
Official title: Notify 2: An Evaluation of the Impact of Notification of Incidental Coronary Artery Calcium on Statin Rates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective is to estimate the impact of notification of primary care provider and patient of at least moderate incidental coronary artery calcification (CAC) on a prior non-gated chest CT on statin prescription rates at 4 months among patients without a clinical history of atherosclerotic cardiovascular disease not actively on statin therapy. This study will determine if notifying patients and their primary care clinician about an existing finding will influence shared decision-making around statins between patients and their primary care clinician.


Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18 and less than 85
2. Non-gated chest CT from 1/1/2016-6/30/2020 with algorithm screening estimating CAC score of at least 100 Agatston Units with radiologist confirmation of moderate or severe CAC
3. Encounter with Palo Alto VA affiliated primary care since 2020

Exclusion Criteria:

1. Prior diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
2. Dementia
3. Metastatic cancer or active cancer undergoing chemotherapy
4. CT coronary angiogram since 2016
5. Invasive Coronary angiogram since 2016
6. CAC scan since 2016
7. Statin therapy within prior 6 months
8. Prior ezetimibe or PCSK9 inhibitor therapy
9. Prior rhabdomyolysis with statin therapy
10. Schizophrenia
11. Substance abuse disorder (alcohol, amphetamines, cocaine, opioids)
12. Hospice
13. Pregnancy

Primary outcomes:
measure: Statin prescription rate
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Veteran's Affairs Hospital
state: California
Study officials:
References:
Clinical trial NCT00576381: Understanding Dexmedetomidine in Neonates After Open Heart Surgery
Official title: The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tetrology of Fallot
Heart Ventricle
Hypoplastic Left Heart
Keywords: Precedex
Open Heart Surgery
Dexmedetomidine
Sedation
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2007-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.

Detailed description: This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in neonates who are immediately post-op from cardiac surgery, and require tracheal intubation with mechanical ventilation in the post-op period.

Pediatric populations may benefit from the favorable pharmacodynamic effects of this medication.

Eligibility criteria: Inclusion Criteria:

* Patients must be less than or equal to 1 month old.
* Postconceptual age must be \> or equal to 37 weeks on the day of surgery.
* Postoperative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
* Planned tracheal extubation within 24 hrs post-op.
* Adequate renal function (serum creatine \< or equal to 1.5mg/dL)
* Adequate liver function (ALT \< or equal to 165 U/L)
* Isolated heart surgery
* Informed consent

Exclusion Criteria:

* Patients who have received another investigational drug since birth.
* Patients receiving continuous infusions of muscle relaxants in the post-op setting.
* Pateints who have a positive blood culture without a subsequent negative culture of other evidence of ongoing serious infection.
* Patients who show signs and symptoms of elevated intracranial pressure.
* Post-op hypotension defined by post conceptual age.
* Pre-existing bradycardia defined by age
* Heart block
* Weight \< 2kg
* Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study

Primary outcomes:
measure: PK Profile of Dexmedetomidine
timeFrame: A sparse PK sampling method was utilized. Between 6-12 PK samples were drawn : After start of infusion (0.5, 4-6, 8 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2-4, 6-8, 10-12 & 18hrs)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Felice Su, MD
role: PRINCIPAL_INVESTIGATOR
References: