louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04460339: Thermoregulation During a 25-km Open Water Race
Official title: Changes in Body Core Temperature During a 25-km Open Water Race in Elite Swimmers: Identifying Predictors for Hypothermia and Dropouts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia Due to Cold Environment
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the competitors of the 25-km French Open Water Championship who volunteered for this study

Brief summary: Open water swimming is a swimming discipline which takes place in outdoor water such as open oceans, lakes, and rivers. Elite swimmers are exposed to hypothermia when swimming in cold water, especially in long duration races, such as the 25-km race. The objective of this study is to evaluate the change in body core temperature in swimmers with continuous temperature monitoring during a 25-km race. The secondary objective is to identify the predictors of hypothermia and hypothermia-related drop-out.


Eligibility criteria: Inclusion Criteria:

* competitors of the 25-km French Open Water Championship
* participants who volunteered for this study
* written consent was obtained from all participants, as well as their legal representatives when applicable (i.e. parents for under age participants).

Exclusion Criteria:

* swallowing disorders
* transit disorders
* MRI scheduled within 48 hours

Primary outcomes:
measure: Change in Body Core Temperature
timeFrame: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer
measure: Change in Water Temperature
timeFrame: Continuous measurement was collected from 30 minutes before the race until 2 hours after the end of the race for each swimmer
Secondary outcomes:
measure: Body composition, body mass
timeFrame: One measurement assessed the day before the race
measure: Body composition, fat mass
timeFrame: One measurement assessed the day before the race
measure: Body composition, fat-free mass
timeFrame: One measurement assessed the day before the race
measure: Body composition, muscle mass
timeFrame: One measurement assessed the day before the race
measure: Perception of Cold
timeFrame: One measurement assessed immediately at the end of the race
measure: Performance
timeFrame: Time at each lap of 2500m and at the end of the race
measure: Dropout rate
timeFrame: During the swimming race and data were collected immediately after dropout for each swimmer who dropped out
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
affiliation: CHU Caen Normandie
name: Joffrey Drigny, MD MSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02585739: Cluster Headache and SPINK-1 Gene
Official title: Cluster Headache and SPINK-1 Gene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episodic or Chronic Cluster Headache
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Cluster headache (CH) is a rare, excruciating primary headache disorder. A genetic basis has been suggested by family and twin studies, but the mode of transmission seems to vary and the amount of heritability is unclear.

The number of genetic association studies investigating variants implicated in the pathophysiology of CH is limited. The HCRTR2 1246G \> A and the ADH4 925A \> G polymorphisms have been associated with CH. The former has been confirmed and may affect the hypothalamic hypocretin system. The aim of the present study was to investigate the possible link between SPINK 1 gene and cluster headache.


Eligibility criteria: Inclusion Criteria:

* People aged 18 or over
* Patient consulting in Marseille's or Nice's Pain departments
* Patient agreeing to participate to the research study
* Patient with health insurance

Exclusion Criteria:

* People aged under 18
* Patient refusing to participate to the research study
* Patient with deprivation of liberty

Primary outcomes:
measure: SPINK1 genotyping
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM
Study officials:
affiliation: APHM
name: urielle desalbres
role: STUDY_DIRECTOR
References:
Clinical trial NCT03642639: A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms
Official title: A Prospective, Multi-center, Single Arm Study to Obtain "Real World" Clinical Data and Characterize the Acute and Long-term Performance of the MICRUSFRAME and GALAXY Coils Including the PulseRider Aneurysm Neck Reconstruction Device for the Endovascular Treatment of Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aneurysms
Lead sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 850
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Detailed description: A registry to collect real world data on the use of Cerenovus coils. The study will be a post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Eligibility criteria: Inclusion Criteria:

1. Patient is between 21 and 80 years of age
2. Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils
3. Patient is able and willing to comply with protocol and follow-up requirements

Exclusion Criteria:

1. Pre-planned staged procedure on unruptured aneurysm
2. More than one aneurysm requiring treatment during the course of study
3. Fusiform aneurysm

Primary outcomes:
measure: Occlusion Rate
timeFrame: 12 Months
Secondary outcomes:
measure: 1. Packing Density
timeFrame: From enrollment to end of treatment at 12 months
measure: 2. Complete occlusion rate
timeFrame: 12 month
measure: 3. Recanalization Rate
timeFrame: 12 Months
measure: 4. Device related serious adverse events
timeFrame: 12 Months
measure: 5. Retreatment Rate
timeFrame: 12 Months
measure: 6. Modified Rankin Score
timeFrame: 12 Months
measure: 7. Length of hospital stay
timeFrame: From enrollment to 12 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Toledo
country: United States
facility: Mercy Health St. Vincent Medical Center
state: Ohio
city: Kortrijk
country: Belgium
facility: Az Groeninge
Study officials:
affiliation: Mount Sinai Hospital, New York
name: Reade De Leacy
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Health St. Vincent Hospital
name: Osama Zaidat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03537339: Prospective Investigation of Cardiovascular Risk Factors in Tumor Patients
Official title: Prospective Investigation of Cardiovascular Risk Factors in Tumor Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardioncology
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 500
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: Diagnosed cancer by pathology in National Cancer Center/ Cancer Hospital , Chinese Academy of Medical Sciences and Peking Union Medical College from January 2018 to December 2020

Brief summary: In this study, prospective cohort study was used to collect the general information of patients' sex, age, previous history, family history, electrocardiogram, echocardiography, cardiac biomarkers TnT, BNP, biochemical examination, and clinical treatment of the patients who diagnosed cancer by pathology in National Cancer Center/ Cancer Hospital , Chinese Academy of Medical Sciences and Peking Union Medical College from January 2018 to December 2020. This study intends to evaluate and screen the cardiovascular risk of tumor patients during antitumor therapy and to establish a model of cardiovascular risk assessment for tumor patients, providing clinical evidence for the prevention of cardiovascular disease risk associated with cancer patients.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of malignant tumor by pathology or cytology
2. Age 18-80, KPS \> 70
3. Epidemiological information, clinical diagnosis and treatment and key information of medication are not missing.
4. The liver and kidney function were in the normal range.
5. All selected patients signed informed consent.

Exclusion Criteria:

1. patients diagnosed with congenital heart disease, cardiomyopathy, heart failure, arrhythmia, myocardial ischemia and myocardial infarction within 6 months before enrollment.
2. Severe impairment of liver and kidney function.
3. Left ventricular ejection fraction \< 50% by echocardiographic examination.
4. Diagnosis of more than one kind of tumor at the same time.
5. History of surgery and trauma within 3 months before enrollment.
6. Poor compliance

Primary outcomes:
measure: Adverse events (AEs) related to Cardio-oncology
timeFrame: January 2018 to December 2020.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fei Ma
state: Beijing
Study officials:
References:
Clinical trial NCT02741739: Study of the Blood Concentrations of Two Formulations of REGN1033 in Healthy Subjects
Official title: A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of REGN1033 Produced From Two Different Cell Lines in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug concentration
REGN1033
blood
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-04-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Primary Objective: Determine blood concentrations of two formulations of REGN1033.

Secondary Objective: Assess safety and tolerability of REGN1033.


Eligibility criteria: Key Inclusion Criteria:

1. Healthy males and females (not of childbearing potential) between the ages of 18 and 65 years
2. Body weight between 50.0 kg and 95.0 kg
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Key Exclusion Criteria:

1. Donation or loss of approximately 400 mL or more of blood within 8 weeks prior to dosing, or plasma up to 14 days prior to dosing
2. Hemoglobin not within normal limits
3. Positive drug and alcohol screen test results at screening visits 1 and 2
4. Low or elevated blood pressure and/or heart rate after 3 minutes resting in the seated position:
5. Recent use (within 3 months prior to screening) of androgenic steroids
6. Participation in any clinical research study that evaluated another investigational drug or therapy within 30 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the screening visit
7. Previous exposure to any biological therapeutic agent, except vaccines
8. Known sensitivity to tamoxifen, doxycycline, or similar compounds (ie, tetracyclines)
9. Pregnant or breastfeeding women, and women of childbearing potential
10. Sexually active men who are unwilling to practice adequate contraception during the study

Primary outcomes:
measure: Serum REGN1033 concentration-time curve (AUC)
timeFrame: Pre-dose to day 57
measure: Peak REGN1033 concentration (Cmax)
timeFrame: Pre-dose to day 57
Secondary outcomes:
measure: Treatment-emergent adverse events (TEAEs) from baseline to the end of the study
timeFrame: Day 1 to end of study (Day 57)
measure: Presence or absence of anti-drug antibody (ADA)
timeFrame: Day 1 to end of study (Day 57)
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT04686539: Synthetic CBD as a Therapy for COVID-19
Official title: Synthetic CBD Oil Droplets as a Therapy for Mild to Moderate SARS-CoV-2 Infection. Assesment of Efficacy and Safety.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Covid19
CBD
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-12-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aim to test proof of concept of CBD treatment for efficacy and safety in patients suffering with mild COVID-19 infection. The CBD will be delivered via oil droplets not containing THC, compared to placebo.


Eligibility criteria: Inclusion Criteria:

* COVID 19 patients
* 18 Years and older

Exclusion Criteria:

* Respiratory failure requiring mechanical ventilation
* Intensive care unit admission
* Neutrophile con. \< 1000 cells/mm3
* Lymphocyte con \< 500 cells/mm3
* Liver enzymes 5 times higher then the norm
* QT interval longer then 500 ms.
* Pregnancy
* Hemodialysis renal replacement therapy
* Active or prior psychotic event

Primary outcomes:
measure: Clinical deterioration
timeFrame: 14 days
Secondary outcomes:
measure: Changes in NEWS scale
timeFrame: 14 days
measure: Supportive care therapies
timeFrame: 14 days
measure: SARS-COV2 presence
timeFrame: 10 days, 14 days
measure: Hospitalization Days
timeFrame: 14 days
measure: Cytokine Levels
timeFrame: Day 3, day 7, discharge day (which is on average the 10th day of hospitalization).
measure: Hamilton Anxiety Score
timeFrame: 14 days
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center, Tel Hashomer
state: Tel Aviv
Study officials:
affiliation: Head of Internal Medicine ward "B", Sheba Health Center, Tel Hashomer
name: Howard Amital, MD, MHA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06494839: Outcomes of Bipolar Electrocautery Tonsillectomy Versus Cold Steel Dissection Pediatric Tonsillectomy
Official title: Outcomes of Bipolar Electrocautery Tonsillectomy Versus Cold Steel Dissection Pediatric Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillitis
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 110
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It was intended to practically establish whether or not the relatively newer technique of tonsillectomy like bipolar electrocautery tonsillectomy has any added benefits in reducing the duration of surgery, blood loss and post-operative pain as compared with conventional cold steel dissection method. This study was done to compare the outcomes of bipolar electrocautery tonsillectomy versus cold steel dissection pediatric tonsillectomy.


Eligibility criteria: Inclusion Criteria:

* Patients of 5-13 years of age
* Both genders
* With a history of recurrent episodes of tonsillitis in the last year
* Children who had bilaterally enlarged tonsils
* No history of fever or sore throat in the last 4 weeks

Exclusion Criteria:

* Patients who had enlarged adenoids and required adenotonsillectomy
* Patients who underwent tonsillectomy after quinsy
* With a history of bleeding disorders
* Patients who showed an international normalized ratio (INR) ≥ 1.5

Primary outcomes:
measure: Operative time
timeFrame: 1 hour
measure: Blood loss
timeFrame: up to 24 hours
measure: Postoperative pain
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sir Ganga Ram Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT05925439: Comparison of Tuohy Needle and Quincke Needle During S1 Transforaminal Epidural Injection
Official title: Comparison of the Incidence of Intravascular Injection Using the Tuohy and Quincke Needles During Ultrasound-guided S1 Transforaminal Epidural Injection: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: S1 Transforaminal Epidural Block
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 284
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: Recently, Park et al. introduced a new technique for performing S1 TFESI using ultrasound. S1 TFESI using ultrasound can be considered to overcome the disadvantages of exposure to radiation. We hypothesized that the frequency of intravascular injection differs depending on the type of needle during S1 TFESI under ultrasound guidance.


Eligibility criteria: Inclusion Criteria:

* 1. Patient diagnosed with S1 radiculopathy because S1 root compression was confirmed on MRI and related symptoms 2. NRS of back and/or radiating pain score of 4 or more 3. Patients aged 19 years or older

Exclusion Criteria:

* 1. Cases in which lumbar count is expected to be difficult due to lumbarization, sacralization, or lumbosacral transition 2. When the S1 posterior foramen is not clearly identified on ultrasound 3. Malignancy 4. Systemic infections 5. Bleeding tendency 6. Contrast allergy 7. Pregnant Women 8. If you cannot read or agree to the consent form 9. If you are unable to sign the consent form yourself

Primary outcomes:
measure: incidence of intravascular injection
timeFrame: 1 minute after finishing the procedure
Secondary outcomes:
measure: time required to complete S1 transforaminal epidural block
timeFrame: Baseline, 1 second after the completion of the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
affiliation: Yonsei University
name: Do-Hyeong Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03551639: Application of Real-time PCR Platform for Detection of Vittaforma Corneae Among Patients With Microsporidia Keratitis
Official title: Application of Real-time PCR Platform for Detection of Vittaforma Corneae Among Patients With Microsporidia Keratitis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Microsporidia Keratitis
Microsporidial Keratoconjunctivitis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 0
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected microsporidia infection in eye at the National Taiwan University Hospital (NTUH)

Brief summary: Diagnosis of patients with microsporiosis relies on pathological findings as well as laboratory detection of the causative organism. The conventional laboratory diagnosis of microsporiosis relies on microscopic visualization of the characteristic V. Corneae organisms. We develop a fully automated molecular platform for detection of Vittaforma corneae among patients with microsporidia keratitis.

Detailed description: Clinical infections due to Microsporidium spp. are protean and can be found in humans, insects, and fishes. The most common type of infection is keratitis and mostly is caused by Vittaforma corneae. Diagnosis of patients with microsporiosis relies on pathological findings as well as laboratory detection of the causative organism. The conventional laboratory diagnosis of microsporiosis relies on microscopic visualization of the characteristic V. Corneae organisms. Laboratory tools of identification of V. corneae include Gram staining, Giemsa staining, and modified Ziehl-Neelsen staining of scratching or biopsied specimens of infected cornea. However, the sensitivity of these staining methods is not acceptable due to the variation of specimen quality and quantity, processing, and low load of organisms in the specimens. The BD MAX system (Beckon Dickinson, Diagnostic Systems, Sparks, MD, USA) was introduced in clinical microbiology laboratory of NTUH in 2014 for Pneumocystis jirovecii detection. Till now, no data are available in using this system on V. corneae detection. We develop a fully automated molecular platform for detection of Vittaforma corneae among patients with microsporidia keratitis.

Eligibility criteria: Inclusion Criteria:

Patients with suspected microsporidia infection in eye

Exclusion Criteria:

Primary outcomes:
measure: Microsporidia spp. analysis
timeFrame: 2016/1/1-2018/12/31
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-Chun Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04429139: Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study
Official title: Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinoblastoma
Keywords: Photodynamic therapy
Retinoblastoma
Visudyne
Verteporfin
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 8
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.

Detailed description: Retinoblastoma is the commonest primary intraocular malignancy in infancy and early childhood. Ophthalmologist are trying to seek other more safe and effective treatment modalities to well control the tumor and preserve the visual function. Photodynamic therapy (PDT) is a potentially therapeutic approach for retinoblastoma which has been underestimated. In this study, we are gonging to investigate the the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.

Eligibility criteria: Inclusion Criteria:

* patients with intraocular retinoblastoma of Group A-D

Exclusion Criteria:

* (1) patients with intraocular retinoblastoma of group E; (2) patients with extraocular spread; (3); media opacities such as corneal opacity, significant cataract, or vitreous hemorrhage obscuring fundus examination; (4) patients who were allergic to verteporfin or other benzoporphyrin derivatives.

Primary outcomes:
measure: eye enucleation
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Kunbei Lai
state: Guangdong
Study officials:
References: