louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01253785: Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia
Official title: Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: SterilMed, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, consenting, non-smoking subjects, 18 years or older, both genders and a range of skin tones.

Brief summary: Validate pulse oximeter sensor SpO2 accuracy from 70-100% during induced hypoxia.

Detailed description: The testing is conducted on 10 healthy, consenting, non-smoking subjects in accordance with the IRB approved Protocol. The subjects shall be distributed across both genders and a range of skin tones as equally as practical.

An arterial line will be placed in the radial artery of each subject's right arm, and sensors will be attached to each subject. The subjects will be placed in a semi-supine position and allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip.

Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between 70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide. Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation, based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first 1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be collected via a laptop computer. Concurrent with the end of each blood draw, a marker will be generated on the laptop computers to identify the event.

Eligibility criteria: Inclusion Criteria:

* Non-smoker
* 18 years or older
* Meet the requirements of the investigator's medical history questionnaire criteria which described family history, present symptoms, smoking history, risk factors, nutrition, exercise levels and stress levels
* Understand and provide signed consent for the procedure

Exclusion Criteria:

* Smoker
* User of illegal drugs
* Hypertension
* Respiratory disease
* Known allergy to Lidocaine or its derivatives
* Those suffering from upper respiratory infection on the day of study

Primary outcomes:
measure: SpO2 Accuracy Verification Study (Arms) of ≤ 3.0% between 70-100%
timeFrame: During Analysis - data were collected for all subjects on one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Phillip E Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04307485: A Study of Low Dose vs Standard Ticagrelor on Platelet Function After Intervention for Acute Coronary Syndrome in Senior Patients
Official title: A Randomized Controlled sTudy of Low Dose vs Standard tIcaGrelor on Platelet Function After intErvention for Acute Coronary syndRome in Senior Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Senior Acute Coronary Syndrome Patients After PCI
Lead sponsor: Shanghai Tong Ren Hospital
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigates try to confirm our hypothesis that low dose ticagrelor(60mg) had similar anti-platelets function compared with the standard dose ticagrelor in senior （no less than 75 years old)acute coronary syndrome patients . Totally 40 senior ACS patients will be divided into 2 groups randomly one month after PCI . Group 1 will be treated with ticagrelor 90mg and aspirin 100mg after PCI for 12 months as the standard group; Group 2 will be treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard DAPT treatment. The platelets function will be tested in VASP and TEG methods 2 months after PCI as the primary endpoints.The clinical events will be observed 12 months after PCI.


Eligibility criteria: Inclusion Criteria:

1.Subject must be at least 75 years of age 2 Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome 3.Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure

Exclusion Criteria:

1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
2. Active bleeding
3. Known hypersensitivity or contraindication to study medications
4. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
5. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
6. Subjects with Cerebral hemorrhage history
7. Subjects with stroke history in half a year
8. subjects with active malignant tumor
9. subjects with whom oral anticoagulants are needed
10. Other conditions which the investigators think not applicable to the study.

Primary outcomes:
measure: changes of PRI detected by VASP methods
timeFrame: changes of PRI from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI
measure: changes of Maximum Amplitude (MA) detected by TEG
timeFrame: changes of MA from baseline (4weeks after index PCI) to 8 and 12 weeks after index PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: shanghai Tongren hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03146585: Glycocalyx Damage in Critically Ill Patients
Official title: Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Glycocalyx
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 40
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: All patients admitted to ICU meeting inclusion criteria.

Brief summary: The hypothesis to be tested: GCX damage and its dynamics correlate to various patient related factors and to using organ-supporting measures. There is a correlation between length of organ support and GCX damage.

The aim of the study: Evaluation of the relationship between GCX damage and duration of various organ supporting measures.

Type of the study: Observational. Subjects: Adult patients admitted to ICU and requiring organ supporting therapy.

Sample size: We plan enrollment of 75 patients on invasive ventilatory support in the duration of least 5 days, 50 patients on renal supporting therapy lasting at least 5 days and 20 patients with target temperature management for neuroprotection.

Intervention: none Data to be recorded and analysed: Demographics, type of patients (trauma, post surgical, medical, after cardiac arrest), severity score - Apache II, SOFA, fluid balance, presence of delirium, clinical outcome, sublingual microcirculation by SDF imaging at time points: before or at the start of organ support, after 24 hours (day 1), day 3, 5, 7 and/or at discharge or before death, microcirculatory data, and Perfused Boundary Region.


Eligibility criteria: Inclusion Criteria:

* adult patients admitted to ICU
* artifitial ventilation
* renal replacement therapy
* targeted temperatura management

Exclusion Criteria:

* pregnant women

Primary outcomes:
measure: Perfused Boundary Region (PBR) in One Week
timeFrame: One week on ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
state: Třebeš
Study officials:
affiliation: University Hospital Hradec Kralove
name: Vladimir Cerny, MD, PhD, FCCM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03351985: The Study of Post-operation Delirium and Prognosis of Cardiac Surgery Patients
Official title: the Effect of Quantitative Electroencephalogram (qEEG) in Predictive of Post-operation Delirium and Prognosis of Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients receiving cardiac surgery

Brief summary: Delirium is the most common neurological complication of cardiac surgery patients and associated with poor prognosis. In recent years, the important role of quantitative electroencephalogram (qEEG) in brain function monitoring is becoming increasingly prominent. The purpose of this study is to evaluate the effect of qEEG in predictive of post-operation delirium and prognosis of cardiac surgery patients.


Eligibility criteria: Inclusion Criteria:

1. The patients of cardiac surgery aged ≥18 years
2. Signed informed consent

Exclusion Criteria:

1. Patients with a history of any neurologic and psychiatric disease
2. Cognitive disorder
3. Stroke history in three years

Primary outcomes:
measure: amplitude integrated electroencephalogram (aEEG)
timeFrame: 24 hours
Secondary outcomes:
measure: alpha frequency band energy
timeFrame: 24 hours
measure: beta frequency band energy
timeFrame: 24 hours
measure: theta frequency band energy
timeFrame: 24 hours
measure: delta frequency band energy
timeFrame: 24 hours
measure: alpha variability
timeFrame: 24 hours
measure: arterial oxygen saturation (SaO2)
timeFrame: 24 hours
measure: central venous oxygen saturation (ScvO2)
timeFrame: 24 hours
measure: neuron specific enolase (NSE)
timeFrame: 24 hours
measure: interleukin-6 (IL-6)
timeFrame: 24 hours
measure: troponin i (TNI)
timeFrame: 24 hours
measure: high-sensitivity C-reactive protein (hs-CRP)
timeFrame: 24 hours
measure: N-terminal pro brain natriuretic peptide (NT-pro-BNP)
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Southeast University
name: Liu Wenxue, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01697085: Effects of Sea Buckthorn Oil on Mucous Membranes
Official title: Effects of Sea Buckthorn Oil on Mucous Membranes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mucous Membranes
Keywords: sea buckthorn
mucous membrane
dryness
metabolic syndrome
vaginal atrophy
Lead sponsor: Aromtech Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The Finnish Funding Agency for Technology and Innovation
First posted: 2012-10-02
Enrollment: 116
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Aim of this study is to investigate the effects of intake of sea buckthorn oil on mucous membranes


Eligibility criteria: Inclusion Criteria:

* women experiencing vaginal dryness
* 55-75 years of age
* at least 12 months from menstruation

Exclusion Criteria:

* use of estrogen replacement therapy

Primary outcomes:
measure: Change from baseline in dryness related symptoms of genital mucous membranes
timeFrame: Interviews at baseline, at 2 months, at 3 moths (end of intervention), and daily during the study (symptom logbooks)
Secondary outcomes:
measure: Change from baseline in vaginal pH
timeFrame: At baseline, at 3 months (end of intervention)
Other outcomes:
measure: Change from baseline in vaginal health index, vaginal dryness, vaginal maturity index, symptoms of dryness in other mucous membranes, markers of inflammation, oxidative stress and metabolic disorder in the circulation
timeFrame: At baseline, at 3 months (end of intervention)
Locations:
city: Turku
country: Finland
facility: Turun Gynekologikeskus
Study officials:
affiliation: Turun Gynekologikeskus, Turku, Finland
name: Risto Erkkola, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00848185: Differential Regulation of VEGF, Cadherin, Angiopietin 2 by Trigger Oocyte Maturation With GnRHa vs hCG in Donors
Official title: Differential Regulation of VEGF, Cadherin and Angiopietin 2 by Trigger Oocyte Maturation With GnRHa vs hCG in Donors: Try to Explain the Lower OHSS Incidence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Endothelial Growth Factor Overexpression
Keywords: VEGF
Trigger
OHSS
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: oocyte Donors

Brief summary: Introduction OHSS still remains a complication of assisted reproduction treatments. hCG administration to trigger final oocyte maturation will release vascular mediators, being VEGF and other proteins such as VE-Cadherin or Angiopoietin- 2. It has been shown that replacing hCG by GnRH agonists will induce a very short endogenous LH peak, potent enough to induce final oocyte maturation but no OHSS will develop. The investigators examined VEGF, VE-Cadherin and Angiopoietin-2 modulation by hCG as well as GnRH agonists in oocyte donors undergoing controlled ovarian stimulation.

Detailed description: Material and Methods Between June and December of 2008 we evaluated 90 egg donors. They underwent COH with 150 IU rFSH as starting dose, we separated them in 3 groups (n:30 each): Groups 1 and 2 received a 0.25mg daily dose of GnRH antagonist when a follicle 14mm in diameter was observed. hCG 250g was given to group 1 while group 2 received triptorelin 0.2mg when leading two follicles were 17mm. Group 3 was stimulated with standard long protocol, hCG was given following similar criteria.

Blood was collected the day of hCG/aGnRH administration as well as the day of egg retrieval, and follicular fluid from the first two mature follicles was also frozen. We collected granulosa cells (GC) of 10 patients of each group as well Levels of VEGF, sVE-Cadherin an Angiopietin 2 were determined by ELISA in serum and in follicular fluid.

Results were analyzed via ANOVA.Data are expressed as mean± SEM. A significant difference was defined as p\< 0.05.

Eligibility criteria: Inclusion Criteria:

* Donors

Exclusion Criteria:

* Important diseases

Primary outcomes:
measure: VEGF Protein and mRNA Levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02644785: Serum Tryptase Levels During Cardiac Surgery, Diagnosis and Treatment Decisions for Allergic Reactions
Official title: Investigation of Anaphylactic Reaction in Cases Undergoing Cardiac By-Pass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Protamine Allergy
Protamine Adverse Reaction
Keywords: cardiac by-pass
protamine
tryptase
hypotension
anaphylaxis
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elective cardiac By-Pass surgery cases

Brief summary: The investigators aim to assess tryptase test efficacy for measuring the allergic response to protamine during cardiac bypass surgery. Additionally, the investigators aim to establish a differential diagnosis on the basis of potential allergens or clinical causes.

Detailed description: Venous blood samples from cardiac surgery cases will be obtained for tryptase measurement upon admission to the operating room (OR) and immediately prior to and 30 min after protamine infusion initiation. A rapid effect-response-based clinical assessment will be made using clinical and laboratory monitoring data for diagnosis and treatment decisions during protamine infusion, which may complicate the recovery from surgery.

Eligibility criteria: Inclusion Criteria:

* Cardiac by-pass cases

Exclusion Criteria:

* Insulin dependent diabetes
* Atopy
* Drug allergy history

Primary outcomes:
measure: Patients number with high tryptase level (> 25 µg/L ).
timeFrame: 30 min
Secondary outcomes:
measure: Patients number with allergic reaction involving of 1 or more organ/systems (skin, respiratory, or cardiovascular system) following the study drug infusion. In this study, mainly the cardiovascular and skin symptoms will be focused on.
timeFrame: 30 min
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Mustafa Kemal University Hospital
Study officials:
affiliation: Mustafa Kemal University Medical School
name: Menekse Oksar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krishna MT, York M, Chin T, Gnanakumaran G, Heslegrave J, Derbridge C, Huissoon A, Diwakar L, Eren E, Crossman RJ, Khan N, Williams AP. Multi-centre retrospective analysis of anaphylaxis during general anaesthesia in the United Kingdom: aetiology and diagnostic performance of acute serum tryptase. Clin Exp Immunol. 2014 Nov;178(2):399-404. doi: 10.1111/cei.12424.
citation: Malinovsky JM, Decagny S, Wessel F, Guilloux L, Mertes PM. Systematic follow-up increases incidence of anaphylaxis during adverse reactions in anesthetized patients. Acta Anaesthesiol Scand. 2008 Feb;52(2):175-81. doi: 10.1111/j.1399-6576.2007.01489.x. Epub 2007 Nov 13.
citation: Mertes PM, Laxenaire MC, Alla F; Groupe d'Etudes des Reactions Anaphylactoides Peranesthesiques. Anaphylactic and anaphylactoid reactions occurring during anesthesia in France in 1999-2000. Anesthesiology. 2003 Sep;99(3):536-45. doi: 10.1097/00000542-200309000-00007.
Clinical trial NCT04276285: Laparoscopic Versus US-Guided Subcostal TAP Block After Laparoscopic Cholecystectomy
Official title: Impact of Laparoscopic Versus Ultrasound-Guided Subcostal Transversus Abdominis Plane Block on Pain and Recovery After Laparoscopic Cholecystectomy: A Randomized Double-Blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecystitis; Gallstone
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Zaghiyan et al hypothesized that Laparoscopic TAP was noninferior to US-TAP and performed a randomized clinical trial comparing Laparoscopic TAP, US-TAP, and no TAP in minimally invasive colorectal surgery. The authors reported that LTAP was superior to UTAP in achieving pain control and minimizing opioid use in the first 24 hours after colorectal surgery.

This prospective randomized, controlled trial will be performed to assessed the efficacy of laparoscopic subcostal TAP block (LSTAP) compared to ultrasound-guided subcostal TAP (USTAP) block after laparoscopic cholecystectomy regarding postoperative pain scores in the first 24-hours after the intervention and analgesic requirements.


Eligibility criteria: Inclusion Criteria:

* Consecutive adult patients of either gender who will undergo laparoscopic cholecystectomy will be recruited to the study.

Exclusion Criteria:

* Pregnant women
* Patients who will undergo open cholecystectomy
* Patients who will need conversion to conventional open cholecystectomy
* Patients with ASA III classification or higher
* Patients who will undergo laparoscopic cholecystectomy together with other abdominal interventions.

Primary outcomes:
measure: Pain score
timeFrame: 24 hours after cholecystectomy
Secondary outcomes:
measure: Analgesic requirement
timeFrame: 24 hours after cholecystectomy
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04709185: AVS After 1mg DST to Determine Subtype in PA
Official title: Adrenal Venous Sampling Under 1 mg Overnight Dexamethasone Suppression Test to Determine Subtype in Primary Aldosteronism，a Single Center, Randomized, Double Blended, Placebo Controlled Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Aldosteronism
Keywords: primary aldosteronism
adrenal venous sampling
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare the effect of different procedures of AVS(after 1mg DST or not) in determining the subtypes and long-term outcomes of PA

Detailed description: All paticipants will be randomly divided into 1mg DST group(Intervention group,n=43) and placebo group(Control group,n=43) and to determining the subtypes and to compare the long-term outcomes of patients with PA.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or above, male or female, with legal capacity;
2. Patients who diagnosed as primary aldosteronism and willing to surgery

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients with a history of malignant tumors or complicated with severe heart disease, eGFR\<30ml/min/1.73m2, severe anemia (Hb\<60g/L), stroke or acute coronary syndrome within 3 months, severe liver disease
3. Having contraindications or refusal to undergo AVS or unilateral adrenalectomy, or allergy to ACTH;
4. PA combined with Cushing syndrome (including subclinical Cushing); or considering glucocorticoid-suppressible aldosteronism (GRA) or adrenocortical carcinoma;

Primary outcomes:
measure: Complete biochemical remission
timeFrame: 1year
measure: Complete clinical remission
timeFrame: 1 year
Secondary outcomes:
measure: Daily defined doses of antihypertensive agents
timeFrame: 1 year
measure: Successful catheterization rate
timeFrame: procedure
measure: Adverse events
timeFrame: 3 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
affiliation: Fudan University
name: Xiaomu Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: