louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00382668: A Study of Dasatinib to See How Liver Impaired and Healthy Subjects Process and React to the Study Drug
Official title: Single-Dose Pharmacokinetics of Dasatinib in Subjects With Hepatic Impairment Compared to Healthy Adult Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Keywords: hepatically impaired
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and Female Subjects with hepatic insufficiency conforming to Child-Pugh classification B

Male and Female Subjects with hepatic insufficiency conforming to Child-Pugh classification C

Healthy Control subjects in good health

Brief summary: The primary purpose of this study is to evaluate how a person with liver impairment processes and reacts to the study drug. Information about any side effects that may occur will also be collected.


Eligibility criteria: Inclusion Criteria - All subjects:

* Male and females ≥18 years old
* Women must be of non-childbearing potential
* Adequate hematologic and renal function
* BMI 18-35 kg/m2

Inclusion Criteria - Liver Impaired subjects:

* Subjects must have stable liver impairment diagnosed with standard classification - Child Pugh

Exclusion Criteria - All subjects:

* Inability to swallow or absorb oral medication
* Uncontrolled medical disorder or infection
* Use of CYP3A4 inhibitors/inducers or drugs with risk of Torsades de Pointes
* Uncontrolled or Significant cardiovascular disease
* Any significant bleeding disorder
* Female subjects of childbearing potential
* Male subjects unwilling to use an effective method of contraception throughout the conduct of the study and for 2 months thereafter

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University Of Miami
state: Florida
city: Miramar
country: United States
facility: Comprehensive Phase One
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Knoxville
country: United States
facility: New Orleans Center For Clinical Research
state: Tennessee
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04490668: Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery
Official title: Association of Human Albumin With Anastomotic Leakage After Gastric Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Anastomotic Leak
Keywords: Gastric Cancer
Anastomotic leakage
Human albumin
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 1049
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gastric cancer who underwent gastrectomy with adequate lymph node dissection.

Brief summary: We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

Detailed description: Anastomotic leakage after gastric cancer surgery is not very common but it is a very critical postoperative complication. Anastomotic leakage severely compromises the recovery after surgery. It increases the overall burden of patients and hospital resources. Postoperative mortality is higher in patients with anastomotic leakage.

Human albumin is routinely administered after surgery with a unproven hypothesis that the human albumin is beneficial to prevent anastomotic leakage. We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed gastric cancer
* Patients who underwent radical gastrectomy

Exclusion Criteria:

* Patient who did not undergo gastrectomy

Primary outcomes:
measure: Comparison of the rate of anastomotic leakage
timeFrame: Up to one months after the discharge of last patient
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ruijin Hospital
name: Birendra K Sah, PH D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Chen Li, PH D
role: STUDY_DIRECTOR
affiliation: Ruijin Hospital
name: Zhenggang Zhu, PH D
role: STUDY_CHAIR
References:
Clinical trial NCT04971668: Aromatherapy Versus Gum Chewing on Preoperative Anxiety
Official title: Effect of Aromatherapy Versus Gum Chewing on Preoperative Anxiety in Females Undergoing Gynecological Laparoscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators hypothesized that the use of blend aromatherapy and gum chewing before surgery would reduce preoperative anxiety as assessed by the Speilberger State-Trait Anxiety Inventory (STAI) questionnaire and provide non pharmacological methods to decrease postoperative sore throat, postoperative nausea \& vomiting and postoperative pain.

Detailed description: A written informed consent will be taken from the patients.patients will be assigned randomly to three groups (30 subjects each) either with preoperative aromatherapy (Group A) or gum chewing (Group G) or control group (Group C) to assess the preoperative anxiety and postoperative sore throat, nausea \& vomiting and pain control between the three studied groups.

Eligibility criteria: Inclusion Criteria:

* Educated adult females
* American Society of Anesthesiologists (ASA) physical status I-II
* Listed for elective gynecological laparoscopy surgery under general anesthesia and endotracheal tube (ETT)

Exclusion Criteria:

* Impaired pharyngeal or esophageal function
* Phenylketonuria (contraindication to the sweetener aspartame in chewing gum)
* A fall upper or lower denture (not feasible to chew gum)
* A history of preoperative sore throat, upper respiratory tract illness
* Using steroid or analgesia within the last 48 hour
* Chronic smokers
* Receiving warfarin, heparin, full dose 325 mg aspirin, or clopidogrel
* A history or diagnosis of bleeding diatheses
* Any known allergies to ginger or lavender
* Having head or neck surgery
* History of difficult intubation
* Pregnant women

Primary outcomes:
measure: Preoperative anxiety scale assessed by STAI questionnaire
timeFrame: Preoperative 15 minutes
Secondary outcomes:
measure: Postoperative sore throat (POST) score
timeFrame: Postoperative 24 hour
measure: Postoperative nausea and vomiting (PONV) score
timeFrame: Postoperative 24 hour
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
state: Assuit
Study officials:
affiliation: Omar makram
name: Omar Soliman, MD
role: STUDY_DIRECTOR
References:
citation: Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5.
Clinical trial NCT00630968: S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Official title: Trial Studying the Safety and Efficacy of Keppra® as Adjunctive Therapy in Adult Patients With Uncontrolled Partial Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Levetiracetam
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 1541
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purposes of the study were to obtain further information about the optimal dose and the efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and tolerability profiles of the drug observed during clinical development.


Eligibility criteria: Inclusion Criteria:

* Partial onset seizures, whether or not secondarily generalized;
* at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline;
* using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry.

Exclusion Criteria:

* Presence of known pseudoseizures within the last year;
* presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
* on felbamate with less than 18 months exposure;
* on vigabatrin, but visual field had not been assessed as per recommendation of the manufacturer, i.e., every 6 months;
* uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.

Primary outcomes:
measure: Percentage reduction in seizure frequency.
timeFrame: 16-week treatment period
Secondary outcomes:
measure: To further assess safety.
measure: The patient-weighted Quality Of Life In Epilepsy inventory.
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Steinhoff BJ, Somerville ER, Van Paesschen W, Ryvlin P, Schelstraete I. The SKATE study: an open-label community-based study of levetiracetam as add-on therapy for adults with uncontrolled partial epilepsy. Epilepsy Res. 2007 Aug;76(1):6-14. doi: 10.1016/j.eplepsyres.2007.06.002. Epub 2007 Aug 6.
citation: Somerville ER, McLaughlin DB, Robinson MK, Berkovic SF. Adjunctive therapy of uncontrolled partial seizures with levetiracetam in Australian patients. Epilepsy Behav. 2007 Nov;11(3):338-42. doi: 10.1016/j.yebeh.2007.06.005. Epub 2007 Sep 11.
citation: Genton P, Sadzot B, Fejerman N, Peltola J, Despland PA, Steinhoff B, Rektor I, Wroe S, Maubrey MC, Vandervelden C, van Hammee G, Schlit AF, van Paesschen W. Levetiracetam in a broad population of patients with refractory epilepsy: interim results of the international SKATE trial. Acta Neurol Scand. 2006 Jun;113(6):387-94. doi: 10.1111/j.1600-0404.2006.00647.x.
Clinical trial NCT06384768: Video Training on Pre-Pregnancy Fear of Birth in Male Partners
Official title: The Effect of Video Training on Pre-Pregnancy Fear of Birth in Male Partners: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Childbirth
Keywords: fear
birth
pregnancy
male
online support
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 43
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the effect of an online video training on fears surrounding childbirth given to male partners before the pregnancy of their spouses. The study conducted with 43 male (22 intervention; 21 control) participants. Participants were divided into intervention and control groups. The intervention group was given video training on pregnancy and the birth process. \&#34;Descriptive Information Form\&#34; and the "Male-Childbirth Fear Prior to Pregnancy Scale" was used for data collection. Before the intervention, it was found that the fear level of childbirth was low. The video training given to male partners before the pregnancy of their spouses diminished the fear of birth but did not create a significant difference. These findings support long-term training that includes video tutorials for parents before birth. Interactive, participatory birth preparation training is likely to enhance the training's appeal for male partners.


Eligibility criteria: Inclusion Criteria:

(i) must be married (ii) must be male gender (iii) must participate voluntarily

Exclusion Criteria:

(i) to have a spouse who had been previously pregnant or having a living child.

Primary outcomes:
measure: Fear of Childbirth
timeFrame: From enrollment to the end of the training at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University
Study officials:
References:
Clinical trial NCT05962268: The Effect Of Vıdeo-Based Fıstula Care Educatıon On Hemodıalysıs
Official title: The Effect Of Vıdeo-Based Fıstula Care Educatıon On Hemodıalysıs Patıents' Self-Care Behavıors: A Randomızed Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemolysis
Keywords: fistula care
education
self care
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: This study aimed to determine the effect of face-to-face and video-based education for fistula care on hemodialysis patients' self-care behaviors.

Methods: The study was conducted as a randomized controlled experimental study. Fistula care training was given to the patients in the control group using face-to-face education technique. Fistula care training was given to the patients in the experimental group using a video based technique.

Detailed description: Experimental group: The researcher provided the patient education the on fistula care. In this training, the researcher first verbally explained fistula care to the patients. After the verbal training, a video recording about fistula care was shown to the patients. The patients watched the video recording during dialysis using the TV unit at the bedside. The training took 20 minutes. Patients were allowed to watch the training video twice, at a one-week interval, when they came for hemodialysis treatment after the condition of the patients on dialysis stabilized.

Topics: Video recordings on of fistula care was done by the researchers in the vocational skills laboratory. The video flow plan included the introduction of the materials to be used in fistula care as well as the researcher's presentation of how to manage the fistula. Fistula care steps were performed on the simulation model. In addition, the precautions to be taken during the application and what to do in case of possible complications were also shown.

Literature review, research results, clinicians' opinions, and experts and practices were used in editing the content of verbal training and video recording,

Eligibility criteria: Inclusion Criteria:

* Being 18 years or older,
* Receiving hemodialysis treatment for more than 6 months,
* Having arteriovenous fistula,
* Being able to read, understand and speak Turkish,
* Not having any physical, mental or mental disability restricting daily activities,
* Having no visual-hearing impairment, perception and psychiatric problems,
* Volunteering to participate in the study

Exclusion Criteria:

* Not having arteriovenous fistula,
* Declining to participate in the study

Primary outcomes:
measure: Patient Information Form
timeFrame: 10 minutes
measure: Scale of Assessment of Self-Care Behaviors with Arteriovenous Fistula in Hemodialysis (ASBHD-AVF)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri Dialysis Center
state: Talas
Study officials:
References:
Clinical trial NCT04092868: Heparin Antagonization by Protamine in Cardiac Surgery: Pharmacokinetic/Pharmacodynamic Study
Official title: Heparin Antagonization by Protamine in Cardiac Surgery: Pharmacokinetic/Pharmacodynamic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery Requiring Extracorporeal Circulation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 70
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: patients with cardiac surgery under CEC

Brief summary: Protamine is currently used during cardiac surgery to neutralize unfractionated heparin (UFH) at the end of extra-corporeal circulation (ECC). The optimal dose of protamine is currently unknown, and the administration of protamine is done empirically.

Protamine and UFH pharmacokinetics are characterized by a large inter-individual variability. A dose of protamine proportional to the amount of UFH administrated during the surgery may be therefore not adapted to most of the patients and exposed them to a risk of under or over dosage.

In this study, research investigators hypothesize that an accurate characterization of the pharmacokinetic/pharmacodynamic (PK/PD) relationship of protamine may help to optimize propose an optimal dosing regimen.


Eligibility criteria: Inclusion Criteria:

* Patients benefiting from scheduled or emergency at the Saint-Etienne University Hospital (coronary artery bypass grafting, valve replacements, aortic dissections).

Exclusion Criteria:

* Patients with a contraindication to UFH
* Patients with a contraindication to protamine
* Patients requiring early resurgery.
* Patients receiving an injection of antithrombin III.
* Pregnant women.
* Patient for whom aprotinin use is planned during surgery.

Primary outcomes:
measure: PK/PD Protamine
timeFrame: 1 day
Secondary outcomes:
measure: PK/PD Protamine
timeFrame: 1 day
measure: postoperative blood loss:
timeFrame: 1 day
measure: ratios between the amount of UFH present at the protamine injection and the dose of protamine administered.
timeFrame: 1 day
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Julien LANOISELÉE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00558168: Electronic Study for Anastrozole Pharmacovigilance Evaluation
Official title: Electronic Study for Anastrozole Pharmacovigilance Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Breast Cancer
Keywords: Anastrazole
safety
early breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 1850
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer


Eligibility criteria: Inclusion Criteria:

* Post-menopausal Early Invasive Breast Cancer Patients who are under anastrazole treatment, who have normal renal and hepatic functions.

Exclusion Criteria:

* Metastatic breast cancer patients, previous hormonal therapy, other malignancies.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kadir Has University Medical School
name: Nejdet Uskent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02161068: Clinical Care of Autosomal Polycystic Kidney Disease: Retrospective Analysis and Prospective PKD Genotyping
Official title: Chart Review/PKD Genotyping
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ADPKD
Keywords: ADPKD
Chart Review
PKD Genotyping
Lead sponsor: The Rogosin Institute
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2014-06-11
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients enrolled in this study will have the diagnosis of ADPKD

Brief summary: This is a retrospective analysis to include demographic, clinical, biochemical, and genetic data that will further explore the natural history of ADPKD and assess the factors that are likely to be associated with the progression of disease and the incidence of complications including progressive chronic kidney disease, cardiovascular disease, and cerebrovascular disease.

Detailed description: To explore questions regarding the natural history of PKD, as well as other, unforeseen issues, a comprehensive database of demographic, clinical, biochemical, and genetic data is required. This descriptive retrospective study can serve as a source of information regarding either the entire ADPKD population, or subsets of patients with specifically targeted characteristics. This will inform future prospective studies that will be designed to address issues regarding the natural history and complications of ADPKD.

The goal of this project is to collect data from a large population of patients with PKD. Based upon the estimated prevalence of PKD (1:500 and 1:1000 live births), it is estimated that there may be 10,000 PKD patients in the New York City area. This sample size far exceeds any database established thus far. As many as 40% of affected PKD patients are reportedly unaware of a family history of this disease, in part because many patients may go undiagnosed until they present with a medical complication (e.g., hypertension, kidney failure). Furthermore, this initiative will provide an opportunity to compare data from racially diverse populations.

Eligibility criteria: Inclusion Criteria:

* Subjects should have a confirmed ADPKD diagnosis.

Exclusion Criteria:

* Unable to provide informed consent for PKD Genotyping.

Primary outcomes:
measure: Natural history of ADPKD
timeFrame: Up to 11 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
Study officials:
affiliation: The Rogosin Institute
name: Jon Blumenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: