louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04522310: ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis
Official title: ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Centre Hospitalier de Lens
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult patient admitted in the ICU with COVID-19 pneumonia

Brief summary: COVID-19 is a worldwide pandemic. Around 5% of infected patients are admitted in ICU, mainly for respiratory failure. Outcome of these patients is linked to other organ failures. Optimal therapies are not defined so far. The sponsor want to assess the role of MR-ProADM as prognostic biomarker, and the impact of treatments (including supportive treatments) on MOF occurrence and outcome.


Eligibility criteria: Inclusion Criteria:

* Any adult patient admitted in the ICU with COVID-19 pneumonia

Exclusion Criteria:

* Pregnancy
* Legal reasons (patients under guardianship, curatorship)
* Patient's refusal

Primary outcomes:
measure: Association or correlation between MR-ProADM at day 1 and day 3 and the onset of visceral failures extra respiratory in reanimation.
timeFrame: comparison to day 1 and day 3
measure: mortality at day 28 and day 90.
timeFrame: admission until day 90
Secondary outcomes:
measure: Association between MR-ProADM and mortality at day 28.
timeFrame: admission until day 28
measure: Association or correlation between patient factor or treatment, and the onset or aggravation of visceral failures (day 3 and day 10), evolution until day 28.
timeFrame: admission until day 28
Other outcomes:
Locations:
city: Arras
country: France
facility: Hospital of Arras
city: Boulogne-sur-Mer
country: France
facility: Hospital of Boulogne/mer
city: Douai
country: France
facility: Hospital of DOUAI
city: Dunkerque
country: France
facility: Hospital of Dunkerque
city: Lens
country: France
facility: Hospital Dr Schaffner
city: Roubaix
country: France
facility: Hospital of Roubaix
city: Tourcoing
country: France
facility: Hospital of Tourcoing
city: Valenciennes
country: France
facility: Hospitalier of Valenciennes
Study officials:
References:
Clinical trial NCT01755910: Effect of Thoracic Paravertebral Block on Heart Rate Variability (HRV)
Official title: Effect of Thoracic Paravertebral Block on the Autonomous System as Measured by Heart Rate Variability (HRV)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Surgery
Thoracic Paravertebral Block
HRV
Autonomic Nervous System
Keywords: Breast Surgery
Thoracic Paravertebral Block
HRV
Autonomic Nervous System
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients for elective breast surgery

Brief summary: The Left thoracic paravertebral block have a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block


Eligibility criteria: Inclusion Criteria:

* Elective breast surgery
* Age 20 - 65 years
* ASA I - II

Exclusion Criteria:

* Coagulopathy disorders
* Infection at the puncture site for the thoracic paravertebral block
* Severe kyphoscoliosis
* Allergy to local anesthetics
* BMI \> 35
* Psychiatric disorders
* Patient's refusal
* Problems with patient communication
* Arrythmia
* Ischaemic heart disease
* Diabetes mellitus
* Thyroid function disorders
* Patients with conduction disorders on the ECG
* Electrolyte disorders (K+, Na+, Ca++)
* Patients on medication that affect the ECG

Primary outcomes:
measure: Effect of thoracic paravertebral block on Heart Rate Variability (HRV)
timeFrame: 30 min after the application of the thoracic paravertebral block
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Larissa University Hospital
state: Thessally
Study officials:
affiliation: Larissa University Hospital
name: Marina Simaioforidou, Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Larissa University Hospital
name: George Vretzakis, Medicine
role: STUDY_DIRECTOR
affiliation: Larissa University Hospital
name: Aikaterini Tsiaka, Medicine
role: STUDY_CHAIR
References:
Clinical trial NCT02847910: ClinicaI Observation of Induced Abortion With Disposable Tissue Suction Tube
Official title: ClinicaI Observation of Induced Abortion With Disposable Tissue Suction Tube
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Early Pregnancy
Keywords: tissue suction tube
disposable instrument
induced abortion
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the clinical effect of disposable tissue suction tube set for induced abortion and make comparison with traditional metal instruments．


Eligibility criteria: Inclusion Criteria:

* premedical abortion diagnosed by ultrasound diagnosed
* pregnancy for the first time
* 7-9 weeks of pregnancy
* voluntary termination of pregnancy
* without surgical contraindication

Exclusion Criteria:

* refuse this clinical trial
* with systemic disease such as hypertensive disease, heart disease, diabetes
* refuse to terminate the pregnancy

Primary outcomes:
measure: blood loss (ml)
timeFrame: up to 5-10 minutes
measure: the rate of induced abortion syndrome (%);
timeFrame: up to 5-10 minutes
Secondary outcomes:
measure: evaluate pain grade (0, I, II, III) by questionnaire
timeFrame: up to 5-10 minutes
measure: rate of leaving bed in 5 min by patient self (%)
timeFrame: 5 min after the surgery
measure: operation time (minutes)
timeFrame: up to 5-10 minutes until the operation finished
measure: the success rate of induced abortion (%)
timeFrame: up to 15 days after the surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: The First Affliated Hospital of Xi'an Jiaotong University
name: Qiling Li, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juarez F, Singh S. Incidence of induced abortion by age and state, Mexico, 2009: new estimates using a modified methodology. Int Perspect Sex Reprod Health. 2012 Jun;38(2):58-67. doi: 10.1363/3805812.
citation: Vilela RC, Benchimol M. Trichomonas vaginalis and Tritrichomonas foetus: interaction with fibroblasts and muscle cells - new insights into parasite-mediated host cell cytotoxicity. Mem Inst Oswaldo Cruz. 2012 Sep;107(6):720-7. doi: 10.1590/s0074-02762012000600003.
citation: Albers CE, Steppacher SD, Ganz R, Siebenrock KA, Tannast M. Joint-preserving surgery improves pain, range of motion, and abductor strength after Legg-Calve-Perthes disease. Clin Orthop Relat Res. 2012 Sep;470(9):2450-61. doi: 10.1007/s11999-012-2345-0.
Clinical trial NCT04391010: Effectiveness of Respirators Fit Factor in Healthcare Providers With and Without Beard
Official title: Effectiveness of Respirators Fit Factor in Healthcare Providers With and Without Beard: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Health Workers
Filtration
Masks
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aim will be to determine the fit factor of surgical masks and filtering respirators in healthcare providers with and without beard. A randomized clinical trial will be carried out recruiting a sample of 52 healthcare providers with and without beard. Fit factor will be measured with both surgical masks and filtering respirators and compared between healthcare providers with and without beard.


Eligibility criteria: Inclusion Criteria:

* Healthcare providers

Exclusion Criteria:

* Pulmonary diseases
* Pregnant women
* Not sign the informed consent form

Primary outcomes:
measure: Fit factor
timeFrame: Change from baseline fit factor immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References:
Clinical trial NCT03044210: Metabolic Study of Cockayne Syndrome
Official title: Metabolic Study of Cockayne Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cockayne Syndrome
Keywords: Rest energetic cost measured by indirect calorimetry
Hormonal axis
Mitochondrial oxidative phosphorylation
Basal metabolism
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Cockayne syndrome (CS) is related to defective DNA transcription and/or repair and belongs to the family of Nucleotide Excision Repair. It is an autosomal recessive multisystemic disorder characterized by mental retardation, microcephaly, severe growth failure with lipoatrophia, sensorial impairment, cutaneous photosensitivity, dental decay, enophtalmios. The disease is progressive causing severe impairments but there's currently no therapeutics for the disease.

Growth failure, feeding difficulties and lipoatrophia are prognostic keys of CS but physiopathology is unknown.

According to preliminary assays, our goal is to test the hypothesis that cachexia is due to hypometabolism. We also want to test the potential link between this basal metabolism modification and mitochondrial dysfunction and somatotrope axis, and correlation between the basal metabolism degree and global severity of the disease.


Eligibility criteria: Cockayne patients:

Inclusion criteria :

* Male and female with cockayne syndrome
* Age\>6 months

Exclusion criteria:

* Intercurrent diseases
* Subject in period of exclusion
* Pregnancy and breastfeeding

Control subjects :

Inclusion criteria :

* Sister or brother of Cockayne patients
* Age\>6 months

Exclusion criteria:

* Intercurrent diseases
* Subject in periods of exclusion
* Pregnancy and breastfeeding

Primary outcomes:
measure: Rest energetic cost measured by indirect calorimetry compared to calculated Black equation
timeFrame: Day 0
Secondary outcomes:
measure: Rest energetic cost measured by indirect calorimetry compared to calculated theorical equations
timeFrame: Day 0
measure: Hormonal axis evaluation and mitochondrial activity measured by level of hormones and lactates/pyruvates in blood
timeFrame: Day 0
measure: Respiratory quotient measured by indirect calorimetry
timeFrame: Day 0
measure: Fat mass and lean mass measured by impedancemetry
timeFrame: Day 0
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre d'Investigation Clinique
Study officials:
affiliation: Hôpitauc Universitaires de Strasbourg
name: Marie-Aude SPITZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01572610: A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus
Official title: A Phase 2 GFR Measuring Study of RTA 402 in CKD Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Type 2 Diabetes
Keywords: CKD patients with type 2 diabetes
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-04-06
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

Detailed description: An exploratory study to investigate the effects of RTA 402 on glomerular filtration rate in CKD patients with type 2 diabetes mellitus.

To evaluate the safety of RTA 402.

Eligibility criteria: Inclusion Criteria:

* CKD patients with type 2 diabetes mellitus
* Patients whose eGFR levels are eligible for this study
* Patients being treated with stable dose of ACE inhibitors and/or ARB etc.

Exclusion Criteria:

* Patients with Type 1 diabetes
* Patients with known non-diabetic renal disease
* Patients with a history of renal transplantation
* Patients with mean SBP \> 160 mmHg or mean DBP \> 90 mmHg
* Patients with HbA1C \> 10%
* Patients with cardiovascular disease specified in the study protocol
* Patients for whom Inulead® injection is contraindicated etc.

Primary outcomes:
measure: Efficacy: glomerular filtration rate measured by inulin clearance
timeFrame: Up to 16 weeks
measure: Adverse Event collection and assessment
timeFrame: Up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Koga city
country: Japan
state: Ibaraki
Study officials:
References:
Clinical trial NCT04450810: Role of NLRP3 in Periodontitis and Diabetes
Official title: Evaluation of Serum and Salivary NLRP3 in Periodontitis and Diabetes Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Disease
Periodontal Diseases
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 133
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy controls (n=32), periodontitis (n=34), diabetes (n=33), and a combination of periodontitis + diabetes (n=34)

Brief summary: NLRP3 plays a key role in endothelial function and may be a link for the known interaction of periodontitis and diabetes. The investigators compared the impact of gingival health, periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum NLRP3levels.

Detailed description: The aim of this study was to evaluate a possible association between NLRP3 and gingival health, periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum NLRP3 levels.

Eligibility criteria: Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Clinical attachment level
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: University of Messina
name: Giovanni Matarese
role: STUDY_CHAIR
References:
Clinical trial NCT00294710: A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazide Based Treatment Regimen With Optional Addition of Amlodipine
Official title: A Twenty Six-week, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, hydrochlorothiazide, amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-02-22
Enrollment: 976
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: TREATMENT

Brief summary: This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension


Eligibility criteria: Inclusion Criteria:

* Patients with essential hypertension

Exclusion Criteria:

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of myocardial infarction.
* Other protocol-defined inclusion exclusion criteria also apply.

Primary outcomes:
measure: Change from baseline in diastolic blood pressure after 52 weeks
Secondary outcomes:
measure: Change from baseline in systolic and diastolic blood pressure after 52 weeks
measure: Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks
measure: Achieve blood pressure control target of < 140/90 mmHg after 12 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmieder RE, Philipp T, Guerediaga J, Gorostidi M, Smith B, Weissbach N, Maboudian M, Botha J, van Ingen H. Long-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide. Circulation. 2009 Jan 27;119(3):417-25. doi: 10.1161/CIRCULATIONAHA.107.750745. Epub 2009 Jan 12.
Clinical trial NCT01974310: Postoperative Positioning After Surgery for Macular Holes
Official title: A Randomized Clinical Trial of Face-down Protocol Versus Non-face-down Protocol After Surgery for Macular Holes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
Keywords: Macular Holes
Non face down positioning
Face down positioning
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial.

Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.


Eligibility criteria: Inclusion Criteria:

* Idiopathic macular hole stage II-IV
* Informed consent
* Duration of symptoms ≤ 24 months

Exclusion Criteria:

* Previous vitreomacular surgery
* Myopia ≥ 8 diopters
* Ocular trauma
* Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)

Primary outcomes:
measure: Macular hole closure rate
timeFrame: 3 months
Secondary outcomes:
measure: ETDRS Visual Acuity Gain
timeFrame: 3 months
measure: Degree of postoperative head incline
timeFrame: 3 days
measure: Degree of ocular gas fill
timeFrame: 4 days
Other outcomes:
measure: Frequency of the complications
timeFrame: During 3 months
Locations:
city: Copenhagen
country: Denmark
facility: Glostrup Hospital, University of Copenhagen
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Morten la Cour, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03884010: Accuracy of Anthropometric Equations to Estimate DXA-Derived Skeletal Muscle Mass in Professional Male Soccer Players
Official title: Accuracy of Anthropometric Equations to Estimate DXA-Derived Skeletal Muscle Mass in Professional Male Soccer Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Composition
Keywords: DXA
Soccer players
Skeletal muscle mass
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Professional male soccer players hired into a second professional Mexican division team.

Brief summary: This study aimed to analyze the accuracy of different anthropometric equations to estimate skeletal muscle mass in professional male soccer players, setting dual-energy x-ray absorptiometry (DXA) skeletal muscle mass as the reference.

Detailed description: The study consisted of evaluating anthropometric measurements and body composition with DXA in professional male soccer player aged 18 years and older. Standardized and certified personnel carried out anthropometric measurements and DXA whole body scan the same day.

Skeletal muscle mass was estimated with several anthropometric equations. The reference skeletal muscle mass was obtained assessing appendicular lean soft tissue from a whole-body DXA scan and then transformed into skeletal muscle mass with Kim equation (2002).

The estimated skeletal muscle mass from anthropometric equations was compared with DXA, and those with non-significant differences were further analyzed for calculating mean differences and 95% limits of agreement with DXA. This analysis was carried out for all equations.

Eligibility criteria: Inclusion Criteria:

* Signed contract with the team

Exclusion Criteria:

* Injured

Primary outcomes:
measure: Skeletal muscle mass
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Juan R López-Taylor
role: STUDY_DIRECTOR
References: