louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00287313: Daily Vitamin K in Patients on Warfarin With Unstable INRs
Official title: Use of Daily Vitamin K Supplementation in Patients on Warfarin With a History of Frequent Dose Changes or Variable INRs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anticoagulants
Warfarin
Keywords: Unstable INRs
Warfarin
Vitamin K
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2006-02-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if daily Vitamin K supplementation stabilizes INRs in patients taking warfarin with a history of frequent dose changes or variable INRs.

Detailed description: Consistent daily Vitamin K intake may contribute to the stabilization of INR values in patients with unstable INRs on warfarin therapy. Subjects with unstable INRs will be identified from the existing patient records of the UNC Anticoagulation Clinics. Eligible subjects will sign an informed consent form and will receive a point-of-care (POC) INR monitoring device. They will undergo 9 weeks of home INR monitoring via the POC device (with monthly clinic follow-up). They will subsequently be provided with 500 mcg Vitamin K tablets to be taken once daily. Weekly POC INR monitoring with monthly clinic follow-up will continue for an additional 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Patient of UNC Anticoagulation Clinic with INR target of 2.0-3.0 and at least 9 months on uninterrupted warfarin
* Unstable INRs for the past 6 months, defined as a minimum number of warfarin dose changes of 3
* Patient demonstration of proper POC device technique on 2 measurements during one teaching session with investigator
* Age greater than or equal to 18 years

Exclusion Criteria:

* Stroke or TIA within the previous 12 months
* VTE within the last 3 months
* Antiphospholipid antibody syndrome
* Pregnant patients, since warfarin is contraindicated during pregnancy

Primary outcomes:
measure: Number of warfarin adjustments required in each phase
measure: Time in therapeutic, sub-, and supra-therapeutic range
measure: Variance/SD of INRs for each patient
measure: Adherence assessed by pill counts and pharmacy record review
measure: Thrombotic/bleeding episodes
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Stephan Moll, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00787813: N-Acetyl Cysteine After Cervical Cerclage
Official title: Effect of Oral N-Acetyl Cysteine on Pregnancy Outcome After Cervical Cerclage: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cerclage
Keywords: N-acetyl cysteine (NAC)
Cervical cerclage
cervical cerclage for cervical insufficiency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2008-11-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate the effect of N-acetyl cysteine (NAC) on pregnancy outcome in women undergoing cervical cerclage for cervical insufficiency.

Detailed description: A randomized controlled clinical trial to be carried out in a university-affiliated tertiary center.Participating women will be randomized into two groups: Group A will be given an oral daily dose of 0.6 g of NAC in effervescent form; group B, serving as controls, will not receive NAC.The two groups will then be compared according to pregnancy outcome.

Eligibility criteria: Inclusion Criteria:

* women with history suggestive of cervical insufficiency together with ultrasound findings suggestive of cervical insufficiency undergoing elective cervical cerclage between the 11th and 12th gestational week.
* singelton viable fetus

Exclusion Criteria:

* women tested positive for bacterial vaginosis
* women currently with threatened abortion (vaginal bleeding or uterinecramps)
* age older than 35 years or younger than 20 years
* unwillingness to participate
* irregular and/or uncertain menstrual dates
* rupture of membranes
* previous cesarean delivery
* possible risks for preterm birth in the current or previous pregnancy such as twin pregnancy, IUFD, malpresentation, known fetal anomaly, progesterone or heparin treatment during the current pregnancy, hypertension, and/or seizure disorders.
* women with contra indications for cervical cerclage or anesthesia.

Primary outcomes:
measure: Gestational age at delivery
timeFrame: 3-6 months
Secondary outcomes:
measure: Take home babies, neonatal morbidity
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women's Health Center
Study officials:
affiliation: Women's Health Center, Assiut University, EGYPT
name: AHMED M NASR, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shahin AY, Hassanin IM, Ismail AM, Kruessel JS, Hirchenhain J. Effect of oral N-acetyl cysteine on recurrent preterm labor following treatment for bacterial vaginosis. Int J Gynaecol Obstet. 2009 Jan;104(1):44-8. doi: 10.1016/j.ijgo.2008.08.026. Epub 2008 Oct 11.
citation: Eleje GU, Eke AC, Ikechebelu JI, Ezebialu IU, Okam PC, Ilika CP. Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD012871. doi: 10.1002/14651858.CD012871.pub2.
Clinical trial NCT06496113: Robotic Versus Laparoscopic Liver Resection for Hepatocellular Carcinoma
Official title: Recurrence ad Survival After Robotic Versus Laparoscopic Liver Resection in Very-early to Early (BCLC 0-A) Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent minimally invasive liver resection in centers participating in the study

Brief summary: The objective of the study is to investigate the long-term outcomes of minimally invasive liver surgery (robotic vs laparoscopic) for hepatocellular carcinoma patients of stage BCLC 0-A. Data from two tertiary centers for liver surgery will be retrospectively reviewed. Patients will be divided in two cohorts (robot; laparoscopy). The primary endpoint will be recurrence-free and overall survival; secondary endpoints were incidence, pattern, and treatment of recurrences.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing robotic and laparoscopic resections
* Histology-confirmed HCC of stage BCLC 0-A
* Preserved liver function (Child score A-B)
* Patients \>18 years old

Exclusion Criteria:

* Hand-assisted procedures
* Non-elective surgery
* Intraoperative switch to locoregional therapies (like radiofrequency or microwave ablation)
* Non-histologically confirmed HCC
* Mixed hepato-cholangiocarcinoma.

Primary outcomes:
measure: Recurrence-free survival
timeFrame: From the date of liver resection until the first documented HCC progression on follow-up imaging, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.
measure: Overall survival
timeFrame: From the date of liver resection until the date of death for any cause or the last follow-up available whichever came first, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03294213: Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView
Official title: Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchoscopy
Anesthesia
Lead sponsor: Ambu A/S
Sponsor class: INDUSTRY
First posted: 2017-09-26
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's ≥18 years, Clinical indication and eligible for an airway procedure involving a bronchoscopy procedure, as judged by the Investigator, Patients being admitted in the OR or ICU at the investigational site

Brief summary: This study is designed as a prospective observational, non-controlled, non-interventional study.

The aim of this study is to obtain a broad user perspective of the aScope™ 4 Broncho, focusing on the device functionalities within regular clinical practice and therapeutic use of flexible bronchoscopes in the OR and ICU.

The study will include a minimum of 100 adult patients admitted to the operating room (OR) or Intensive Care Unit (ICU) undergoing at least one bronchoscopy procedure. The inclusion will stop when 100 fully evaluable patients or a maximum of 150 patients have been enrolled.

The involved sites will include patients during a five months' period, from September 2017 to January 2018.

Detailed description: Refer to brief description

Eligibility criteria: Inclusion Criteria:

* Patient's ≥18 years
* Clinical indication and eligible for an airway procedure involving a bronchoscopy procedure, as judged by the Investigator
* Patients being admitted in the OR or ICU at the investigational site

Exclusion Criteria:

- None

Primary outcomes:
measure: User Preference of Scope
timeFrame: Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Klinik für Anästhesiologie, Universitätsmedizin Mainz
state: Rhineland-Palatinate
Study officials:
affiliation: Ambu A/S
name: Pia Nordmand, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT02159313: Relative Bioavailability Study
Official title: Relative Bioavailability Study of Riociguat Given Orally as a Crushed 2.5 mg Tablet Suspended in Applesauce, Crushed 2.5 mg Tablet Suspended in Water, and Whole 2.5 mg Tablet After a Continental Breakfast in Comparison to a Whole 2.5 mg Tablet Given in the Fasted State to Characterize the Pharmacokinetic Properties in Healthy Male Adult Subjects in a 4-fold Crossover Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Biological Availability
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-06-09
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To investigate relative bioavailability of crushed tablets suspended in apple sauce or water


Eligibility criteria: Inclusion Criteria:

* Healthy male subject
* Age: 18 to 45 years (inclusive) at the first screening examination
* Ethnicity: white
* Body mass index (BMI): \>18 and \<29.9 kg/m2

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, or effects of the study drug will not be normal
* History of coronary artery disease
* Symptomatic postural hypotension (e.g. dizziness, lightheadedness)
* History of bronchial asthma or any other airway disease
* Smoking (former smokers who have stopped smoking at least 3 months before the first study drug administration may be included)
* Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 ms or of the QTc interval (QT interval corrected for heart rate) over 450 ms
* Systolic blood pressure below 100 or above 145 mmHg
* Diastolic blood pressure below 50 or above 95 mmHg
* Heart rate below 45 or above 95 beats per minute

Primary outcomes:
measure: Pharmacokinetics of riociguat in plasma by Area under the plasma concentration time curve (AUC)
timeFrame: Multiple time points up to day 3
measure: Pharmacokinetics of riociguat in plasma by maximal concentration (Cmax)
timeFrame: Multiple time ponits up to day 3
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05255913: Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries
Official title: Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries (a Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Childhood Caries
Keywords: Caries arrest, early childhood caries, Nanosilver fluoride
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 360
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after sex and twelve months in arresting ECC lesions.

The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ECC.


Eligibility criteria: Inclusion Criteria:

* Children younger than 4 years old.
* The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
* Completion of an informed consent to participate in the study.

Exclusion Criteria:

* Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility.

  * Parental refusal to participate in the study.
  * Allergy or sensitivity to silver or any of the materials included in the study.

Primary outcomes:
measure: caries arrest
timeFrame: 6 months and 1 year
Secondary outcomes:
measure: Comparing parental satisfaction and adverse effects with interventions
timeFrame: 6 months
measure: Evaluating oral health related quality of life of children and their families.
timeFrame: 6 months and 1 year
measure: Assessing caries increment on remaining teeth in the oral cavity other than the tooth/ teeth receiving the preventive agent
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT03109613: PEEP and V/Q Mismatch in Premature Infants
Official title: Selecting PEEP in Ventilated Premature Infants by Reducing Ventilation/Perfusion Mismatch: a Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Respiratory Insufficiency Syndrome of Newborn
Infant, Premature, Diseases
Keywords: Positive end-expiratory pressure
PEEP
Bronchopulmonary Dysplasia
Ventilator Induced Lung Injury
V/Q mismatch
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Christiana Care Health Services
First posted: 2017-04-12
Enrollment: 12
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for gas exchange. This study measures the feasibility of enrolling and completing study maneuvers in premature infants for a prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or level) of PEEP.


Eligibility criteria: Inclusion Criteria:

1. Preterm birth before 32 weeks gestational age by best obstetric estimate, determined by the clinical obstetric team during antepartum admission
2. Birth weight less than 1500 grams, as measured by the clinical team at neonatal admission.
3. Presence of endotracheal intubation and invasive mechanical ventilation
4. Less than or equal to 28 days chronologic age
5. Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) equal to or greater than 0.25 as documented on the bedside infant flow sheet.

Exclusion Criteria:

1. Congenital anomalies, as determined by the clinical supervising physician
2. Current of prior air leak syndrome, as determined by the clinical supervising physician.
3. Non-English speaking parents
4. Non-viable birth, as determined by the clinical supervising physician

Primary outcomes:
measure: Feasibility assessed by rate of successfully study enrollment and completion
timeFrame: Full enrollment (12 subjects)
Secondary outcomes:
measure: Ventilation/perfusion mismatch
timeFrame: 10-20 minutes following each PEEP level change
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Haresh Kirpalani, BM, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04839913: Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Unicentric, Regional Study
Official title: Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Update From an Unicentric, Regional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV Infection
Seroprevalence
Covid19
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a cohort of elective surgical patients admitted to our unit in the 2020 fall period

Brief summary: The investigator analyzed the data of the patients admitted to the surgical department during the period 1St September - 10Th December 2020 to estimate the seroprevalence of SARS-CoV-2 infection in the setting of a non-dedicated COVID-19 hospital and in a mild CoV-2 incidence area and to evaluate the difference of seroprevalence between Spring and Fall seasons in a cohort of patients undergoing surgery.


Eligibility criteria: Inclusion Criteria:

* Patient admitted to our unit who had performed SARS-COV-2 serologic test

Exclusion Criteria:

* age \< 18

Primary outcomes:
measure: SARS-COV-2 seroprevalence
timeFrame: 1St September - 10Th December 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: University of Cagliari
Study officials:
References:
Clinical trial NCT03659513: The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
Official title: Pharmacokinetics of the Drugs and Their Biological Response in ECMO Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Extracorporeal Membrane Oxygenation Complication
Keywords: Hypoxia
ECMO
Antibiotics
Pharmacokinetics
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing ECMO will be invited to participate. In order to determine pharmacokinetics of the drugs, the investgators need at least 10-15 subjects in order to create a pharmacological model. Since the site plan to study 3 antibiotics, propofol and hydromorphone, the investigators calculated the initial sample size at 50

Brief summary: This study will examine the pharmacokinetics of the various, routinely given antibiotics, sedatives, and opioids in patients undergoing venous-venous extra-corporal oxygenation (ECMO). Little is known about the distribution and effectiveness of antibiotics in this particular patient population.

Detailed description: Patients with severe hypoxia that is refractory to traditional therapies are occasionally placed on venous-venous extracorporal membrane oxygenation (vv ECMO) to provide a bridge during the time when lungs alone cannot provide necessary support. This procedure is gaining prominence but it is largely unknown how medications, especially antibiotics, given to the patient on ECMO is distributed throughout the body as compared to patients without ECMO. Since the serum level of medication determines the biological activity of the drug, it is important to know if there is a difference in drug distribution between ECMO and non-ECMO patients. The investigator already collected well-established data on several antibiotics on non-ECMO as a part of FDA labeling. The study will help to determine if the concentration of currently prescribed are sufficient enough to reach their intended concentration in the study.

Eligibility criteria: Inclusion Criteria:

* Patient with respiratory failure undergoing ECMO.

Exclusion Criteria:

* Lack of consent
* Age less than 18 years old
* Hematocrit lower than 7

Primary outcomes:
measure: Pharmacokinetics of the antibiotics - Maximal Serum Antibiotic Concentration
timeFrame: 24 hours
measure: Pharmacokinetics of the antibiotics - Area Under Curve (AUC)
timeFrame: 24 hours
Secondary outcomes:
measure: Clinical effectiveness of antibiotic dosing for ECMO patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jacob Gutsche, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Krzysztof Laudanski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: