louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01691443: Functional Assessment of a Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve
Official title: Preliminary Study of the Substitution of Sensory Deficits of the Hand by a Medical Device Embedded : a Functional Assessment of Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sensory Deficit
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to investigate the effect of vibration feedback on the gripping pressure in the territory of the median nerve.


Eligibility criteria: Inclusion Criteria:

* person between 18 and 45 years old
* affiliation to the french social security system or equivalent
* person signed a consent to participate
* for the patient group: person with post-traumatic sensory deficit in the territory of the right median nerve above the wrist (\<S3 according Zachary modified Dellon).

Exclusion Criteria:

* person with a cognitive pathology incompatible with the use of the device, understanding and implementation of the protocol
* person with a concomitant nerve injury of any other nerve territory,
* person with pain or stiffness inconsistent with the achievement tests
* person with an allergy to any component of the device: polyamide, cotton, nickel, textile glue, rubber, plastic or latex,
* person with an infectious disease or dermatology of the right hand
* person deprived of freedom by judicial or administrative decision
* person hospitalized without their consent
* person under legal protection
* person hospitalized for psychiatric care
* pregnant and parturient women

Primary outcomes:
measure: intra-and inter-individual variance in pressure.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Department of Plastic Surgery of the Hand and Burned - University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Denis Corcella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03451643: Stenting and Resection for Stage IV Colorectal Cancer Endoscopic Stenting and Colorectal Resection in Stage IV
Official title: Comparison Between Endoscopic Stenting and Colorectal Resection in Patients With Stage IV Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasm
Keywords: colorectal cancer
liver metastases
stage IV
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMIZED CONTROLLED TRIAL
Primary purpose: TREATMENT

Brief summary: Patients with Stage IV obstructing colorectal cancer and unresectable liver metastses, with general and local conditions not a risk for coliorectal resection, will be randomized to have either endoscopic stenting or colorectal resection

Detailed description: Patients with obstructing colorectal cancer, Stage IV with not resectable metastases will be considered .

Patients with acceptable general and local conditions, to allow a safe surgical resection will be considered.

Patients will be randomized to have endoscopic stenting or colorectal resection.

All patients will receive postoperative chemio therapy

Eligibility criteria: Inclusion criteria

* Patients with Stage IV obstructing colorectal cancer and liver metastases
* Liver metastases not resectable

Exclusion criteria

-Patients considered at high risk for colorectal resection

Primary outcomes:
measure: MORTALITY
timeFrame: 60 DAYS
measure: SURVIVAL
timeFrame: 5 YEARS
measure: POSTOPERATIVE MORBIDITY
timeFrame: 60 DAYS
Secondary outcomes:
measure: QUALITY OF LIFE
timeFrame: 5 YEARS
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Istituto Pietro Valdoni
city: Rome
country: Italy
facility: University of Rome Sapienza
Study officials:
affiliation: University of Rome
name: antonietta lamazza, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04772443: Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dyslipidemias
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 280
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of DWJ1506 and DWJ1507 in the patients with dyslipidemia.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 years or over
2. Patients with LDL-C levels ≤ 250 mg/dL, TG \< 500 mg/dL
3. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria:

1. Severe congestive hear failure
2. Current active liver disease
3. The use of prohibiterd concomitant therapies
4. Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.

6.Women who were of childbearing potential without contraception, pregnant, or breastfeeding

Primary outcomes:
measure: LDL-C levels at week 8
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06194643: Platelets in Pregnancy
Official title: Pregnancy Outcomes and Platelet PhenotYpes (POPPY)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertensive Disorder of Pregnancy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant people at high and low risk of preeclampsia and other adverse perinatal outcomes.

Brief summary: This is a prospective observational cohort study of platelet phenotype in pregnant patients at high-risk for the development preeclampsia. Blood samples will be collected prior to the initiation of daily aspirin and again in the second trimester to evaluate for platelet changes during pregnancy in patient's as a result of aspirin use and their association with adverse perinatal outcomes.


Eligibility criteria: Inclusion Criteria (Case Group):

* Pregnant patients receiving prenatal care prior to 17 weeks at NYU Langone Health- Obstetrics \& Gynecology Associates
* Age 18-50 years
* Singleton viable gestation
* Pregnant patients at high risk of preeclampsia: Patients meeting USPSTF recommendation for low-dose aspirin (81 mg/day) prophylaxis for preeclampsia based on clinical risk factors (see below)

Inclusion Criteria (Control Group):

* Pregnant patients receiving prenatal care prior to 17 weeks at NYU Langone Health- Obstetrics \& Gynecology Associates
* Age 18-50 years
* Singleton viable gestation
* Pregnant patients at low risk of preeclampsia: Patients who do not meet USPSTF recommendation for low-dose aspirin (81 mg/day) prophylaxis for preeclampsia based on clinical risk factors.

Exclusion Criteria (Case and Control Group):

* Allergy to aspirin
* Antithrombotic or antiplatelet therapy
* Anemia (hemoglobin \<10 g/dl) or thrombocytopenia (Platelet count \<100,000), or thrombocytosis (Platelet count \>600)
* Known hemorrhagic diathesis
* Planned delivery outside of NYU

Primary outcomes:
measure: Number of Individuals with Overactive Platelets
timeFrame: Blood Draw 1 (taken between Weeks 6 and 14)
measure: Number of Individuals with Overactive Platelets
timeFrame: Blood Draw 2 (taken between Weeks 24 and 28)
Secondary outcomes:
measure: Incidence of Adverse Pregnancy Outcomes
timeFrame: Day 30 Post-Delivery (Up to Month 11)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Christina A. Penfield, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02851043: Non-Invasive Respiratory Monitor
Official title: Non-Invasive Respiratory Monitor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromuscular Diseases
Healthy Volunteers
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will clinically evaluate a newly developed respiratory monitor - pneuRIP. The pneuRIP uses Respiratory Inductance Plethysmography (RIP) bands to measure key breathing indices non-invasively. This study compares the pneuRIP to an existing Respitrace system (Carefusion, Yorba Linda CA). 10 normal children and 10 children with breathing difficulties will be monitored with both systems.

Detailed description: Firstly, ten healthy children will participate in a trial to evaluate the pneuRIP. They will be fitted with the bands around their abdomen and chest. The pneuRIP will be connected to the bands through electrodes. Breathing is then measured wirelessly with an iPad. They will be asked to lie down. They are asked to breath normally then asked to breath with a resistive elements to place in their mouth. The resistive elements makes it difficult to breath (similar to breathing through a straw). They will breathe for 3 minutes for both conditions as we record their breathing with the pneuRIP and the Respitrace. These data will be compared.

Secondly, A group of 10 subjects from the outpatient muscle clinic will be fitted with the chest and abdomen bands. The Respitrace monitor and the pneuRIP will record their breathing patterns. Data from the two systems will then be compared.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Neuromuscular disease subjects with mild breathing difficulty
* Capable of following verbal instructions

Exclusion Criteria:

* Severe breathing difficulties

Primary outcomes:
measure: Breathing rate
timeFrame: Immediately after test
Secondary outcomes:
measure: Labored breathing Index
timeFrame: Immediately after test
measure: Phase Difference
timeFrame: Immediately after test
measure: Percent rib cage
timeFrame: Immediately after test
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours/A.I. duPont Hospital for Children
state: Delaware
Study officials:
affiliation: Nemours
name: Thomas Shaffer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01560143: Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
Official title: Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2012-03-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: If tigecycline clearance increases with body size then serum exposure values will be lower in obese class III compared to normal weight subjects because exposure changes inversely with clearance when the dose is fixed without regard to weight.

Detailed description: Not required

Eligibility criteria: Inclusion Criteria:

Subjects fulfilling the following criteria will be eligible:

1. males and females, 18 to 50 years of age;
2. non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;
3. Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);
4. female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period

Exclusion Criteria:

1. history of significant hypersensitivity reaction to any components of Tygacil®;
2. history of significant clinical illness requiring pharmacological management;
3. history of blood donation in the past eight week period;
4. abnormal serum electrolyte or complete blood count requiring further clinical work-up;
5. transaminases (AST or ALT) \> 2.5 x upper limit of normal;
6. subjects with stage 4 or 5 chronic kidney disease;
7. positive serum pregnancy test (if female);
8. abnormal electrocardiogram (ECG) as judged by study physician;
9. unable to tolerate venipuncture and multiple blood draws;
10. clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up;
11. unable to independently provide a written informed consent.

Primary outcomes:
measure: Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours
timeFrame: 4 days (96 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany College of Pharmacy
state: New York
Study officials:
affiliation: University of Michigan
name: Manjunath P Pai, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pai MP. Serum and urine pharmacokinetics of tigecycline in obese class III and normal weight adults. J Antimicrob Chemother. 2014 Jan;69(1):190-9. doi: 10.1093/jac/dkt299. Epub 2013 Jul 23.
Clinical trial NCT02394743: Correlation Between Estimated Glomerular Filtration Rate(eGFR) and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: Glomerular Filtration Rate
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 360
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who took 18FDG- PET in Korea Guro University

Brief summary: Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. Renal insufficiency is close correlation with atherosclerosis and cardiovascular mortality.

18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.Therefore, the purpose of the study is to demonstrate the correlation between eGFR and vascular inflammation detected by 18F FDG-PET.


Eligibility criteria: Inclusion Criteria:

1. absence of prior cancer diagnosis or remission from cancer at the time of PET imaging and throughout the follow-up period;
2. \>=30 years of age;
3. no prior history of cardiovascular disease ; and
4. absence of acute or chronic inflammatory or autoimmune disease (based on documented medical history) or use of chronic anti-inflammatory therapy.

Exclusion Criteria:

1. age \<35 years
2. presence of chronic inflammatory disease
3. use of anti-inflammatory medications
4. presence of active malignant cancer (defined as any radiological or pathological evidence of malignant cancer disease or undergoing chemotherapy or radiation therapy within 1 year before initial PET/CT and throughout the inter-scan duration).

Primary outcomes:
measure: Correlation between vascular inflammatory status measured by 18F FDG-PET and eGFR by Modification of Diet in Renal Disease(MDRD) formula
timeFrame: at 1 day of taking 18F FDG - PET
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Korea University College of Medicine
state: VD
Study officials:
References:
Clinical trial NCT03488238: Correlation of Changes in PaO2 and ORi in Adult Patients
Official title: Correlation of Changes in PaO2 and ORi in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Hyperoxia
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2018-04-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above. This is a prospective, non-blinded, non-randomized study of the Oxygen Reserve Index (ORi) in a clinical setting. It is designed to evaluate the correlations with ORi and changes in PaO2 and the potential use of ORi as an early warning of impending arterial oxygen desaturation.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* ASA physical status III or IV
* Scheduled for an elective surgical procedure requiring endotracheal intubation and the use of an arterial pressure monitoring catheter placed prior to induction of general anesthesia

Exclusion Criteria:

* Age less than 18 years
* Adults unable to give primary consent
* Pregnancy
* Prisoners

Primary outcomes:
measure: Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
timeFrame: Less than 30 mins
measure: Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
timeFrame: Less than 30 mins
measure: Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
timeFrame: Less than 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
Study officials:
References:
Clinical trial NCT01499238: Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn
Official title: Comparison of Nasal CPAP and Nasal SIMV in Transient Tachypnea of Newborn
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Transient Tachypnea of Newborn
Keywords: Efficacy
safety
nasal SIMV
nasal CPAP
infants who are >35 gestational week with wet lung
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to compare the efficacy of nasal SIMV and nasal CPAP in patients with wet lung.

Detailed description: We aimed to compare two types of ventilatory support in cases of transient tachypnea of newborn who are \>35 gestational week.

Eligibility criteria: Inclusion Criteria:

* \>35 gestational week
* wetlung

Exclusion Criteria:

* major congenital anomalies

Primary outcomes:
measure: efficacy of nasal SIMV and nasal CPAP in infants with wet lung who are >35 weeks gestational age
timeFrame: 3 months
Secondary outcomes:
measure: Complications of respiratory support, respiratory insufficiency
timeFrame: 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Gamze Demirel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00669838: Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study
Official title: Loco Regional Anesthesia for Dental Treatment in Cardiac Patients: Comparative Study Between Plain Lidocaine 2% and Lidocaine 2% With Epinephrine 1:100.000
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias
Anxiety
Keywords: Anesthesia, Local
Lidocaine
Dental care
Arrhythmias, Cardiac
Anxiety
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-05-01
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acquired valvular diseases participated in this study, aging between 18-65 years in need of dental surgery (extractions) or restorative dentistry in mandible

Brief summary: Prospective, randomized double-blinded study to investigate hemodynamic changes in valvular cardiac patients during dental treatment with the use of a local anesthesia containing epinephrine.

Detailed description: Patients with valvular disease constitute a group in which local anesthesia must be effective to avoid higher release of endogenous catecholamines that could trigger hemodynamic. The study was conducted in the Dental Department of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (Brazil). Patients were allocated into two groups through an aleatory numbered table: PL (plain 2% lidocaine, n= 31) and LE (2% lidocaine with 1:100.000 epinephrine, n= 28). The anesthetic amount was registered. DIXTAL monitor (São Paulo- Brazil) captured blood pressure, heart rate, oxygenation and electrocardiogram records.

Eligibility criteria: Inclusion Criteria:

* Patients with acquired valvular disease

Exclusion Criteria:

* Patients having platelets counting lower than 70.000 or INR \> 3

Primary outcomes:
measure: arrhythmias
timeFrame: during procedure
Secondary outcomes:
measure: Arterial pressure
timeFrame: during procedure
measure: anxiety
timeFrame: during and imediately after procedure
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas da FMUSP
Study officials:
affiliation: University of Sao Paulo Medical School - FMUSP
name: Joaquim E Vieira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: