louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00605722: A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.
Official title: A Single Arm, Open Label Study of First Line Treatment With Tarceva Plus Avastin on Progression-free Survival in Patients With Advanced or Metastatic Liver Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 51
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: This single arm study evaluated the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer. Patients were treated with Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks. The anticipated time on study treatment was until disease progression, and the target sample size was \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, ≥ 18 years of age;
* advanced or metastatic liver cancer;
* ≥ 1 measurable lesion, not previously treated with local therapy within 4 weeks of enrollment.

Exclusion Criteria:

* prior or concomitant systemic anti-cancer treatment for advanced disease;
* patients at high risk of variceal bleeding;
* clinically significant cardiovascular disease;
* major surgery, open biopsy, or significant traumatic injury within 4 weeks of study start.

Primary outcomes:
measure: Percentage of Participants With Progression-free Survival (PFS)
timeFrame: Week 16
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Event driven (median follow-up 12 months)
measure: Disease Control Rate (DCR)
timeFrame: Event driven (median follow-up 12 months)
measure: Time to Tumor Progression
timeFrame: Event driven (median follow-up 12 months)
measure: Progression-free Survival (PFS)
timeFrame: Event driven (median follow-up 12 months)
measure: Overall Survival (OS)
timeFrame: Event driven (median follow-up 12 months)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 107 Weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
city: Manila
country: Philippines
city: Kueishan
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01242722: Evaluation of Left Ventricular Autothreshold, Phase Two
Official title: Evaluation of Left Ventricular Autothreshold, Phase Two
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
auto threshold
pacing
CRT-D recipients
Left Ventricular (LV) evoked response signals
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be a sample of patients with COGNIS CRT-D devices and bipolar LV leads.

Brief summary: This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.

Detailed description: ELEVATE 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold (LVAT) feature.

Eligibility criteria: Inclusion Criteria:

* Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without a right atrial lead
* Patients who have an active LV bipolar lead
* Patients who have an active right ventricular (RV) defibrillation lead
* Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
* Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Patients who have a COGNIS CRT-D that has less than or equal to one year of battery life remaining
* Patients who are pacemaker-dependent
* Patients who will not tolerate a pacing pause of up to 6 seconds
* Patients who have a unipolar LV pace/sense lead, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
* Patients with pre-existing leads other than those specified in this investigational plan
* Patients with a pre-existing unipolar pacemaker
* Patients who are unable or unwilling to maintain a supine or sitting position for 40-50 minutes
* Patients enrolled in any concurrent study, without Boston Scientific written approval
* Women who are pregnant

Primary outcomes:
measure: Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing
timeFrame: At least 24 hours post CRT-D implant
Secondary outcomes:
Other outcomes:
Locations:
city: Stuebenville
country: United States
facility: Regional Cardiovascular Medical Center
state: Ohio
Study officials:
affiliation: Virginia Commonwealth University Health System
name: Kenneth L Ellenbogen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01753622: Physical Exercise Program in Obese and Overweight Pregnant Women
Official title: Effect of a Supervised Exercise Program in Obese and Overweight Pregnant Women on Outcomes and Level of Depression. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: Overweight, obese, pregnant, depression, outcomes
Lead sponsor: Technical University of Madrid
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity and overweight have become an epidemic in the world and its prevalence between pregnant women is especially dangerous. Having a high Body Mass Index (BMI) is also associated with depression disorders and its serious complications during this period.

Detailed description: The aim of our study is to assess whether a specific exercise program during pregnancy has a positive effect on maternal mood and other pregnancy outcomes.

Eligibility criteria: Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish
* Giving birth at Hospital Universitario de Fuenlabrada
* Having a Body Mass Index (BMI) greater than 24.9

Exclusion Criteria:

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not being regular in physical exercise program (minimum adherence 80%)
* Younger than 18 years old

Primary outcomes:
measure: Change from level of depression at the end of the pregnancy
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Maternal gestational weight gain
timeFrame: 40-42 weeks
measure: Maternal outcomes
timeFrame: After labor
Other outcomes:
measure: Fetal weight
timeFrame: After labor
Locations:
city: Madrid
country: Spain
facility: Universidad Politecnica de Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Rubén Barakat, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00708422: Effects of Travatan Z and Xalatan on Ocular Surface Health
Official title: Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and Xalatan®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Keywords: Ocular surface health
OSDI
TFBUT
Glaucoma
Ocular hypertension
Corneal staining
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye).
* Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1.
* IOP controllable and stable on the study medication alone (both eyes).
* Believed to have ocular surface disease (OSD).
* Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye.
* Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs.
* Current use of punctual plugs.
* Women of childbearing potential not using reliable means of birth control.
* Women who are pregnant or lactating.
* Suspected or diagnosed with Sjogrens's syndrome.
* Current use of any brand of artificial tears containing BAK.
* Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
* Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1.
* Current use of contact lenses within 30 days of Visit 1.
* Participation in any other investigational study within 30 days prior to Visit 1.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)
timeFrame: 12 weeks (Day 84)
Secondary outcomes:
measure: Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
timeFrame: 12 weeks (Day 84)
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Judy Vittitoe, RN, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03151122: The Effect of a Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants
Official title: The Effect of Nurse-led Continuous Support Program on Neurodevelopment of Preterm Infants and Psychological Well-being of the Parents: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Infant
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 140
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to establish a continuous nurse-led integrated support program and to exam its impact on preterm infant neurodevelopment.

Research hypotheses include:1. The continuous nurse-led integrated support will have significant impact on preterm infant neurodevelopment; 2.The support program will also have positive effect on parent psychological well-being.

Detailed description: The objective of the study is to establish the continuous nurse-led integrated support program as well as exam its impact on neurodevelopmental health of preterm infants.

Research hypotheses:

1. Compared to control group, the preterm infants in the interventional group will experience significantly better performance on neuromotor, cognitive and social-emotional function at corrected age of 3 month;
2. In comparison with those receiving routine support, parents receiving nurse-led continuous support will have significantly higher parental self-efficacy and exhibited better psychological well-being;
3. Maternal parenting self-efficacy will mediate the relationship between nurse-led support and preterm infant neurodevelopment.

Eligibility criteria: Inclusion Criteria:

* Preterm infants born between 28-36 weeks of gestation;
* Parents residing in the same region for at least 5 years; .Parents agree to participate in the study.

Exclusion Criteria:

* infants with severe perinatal brain injury;
* infant with congenital anomalies

Primary outcomes:
measure: Infant neuro-development assessed by the Ages and Stages Questionnaire (ASQ)
timeFrame: infant neuro-development will be measured at 3 months of corrected age.
Secondary outcomes:
measure: Maternal psychological well-being
timeFrame: assess when infants reach 1 month of corrected age.
measure: Parental self-efficacy assessed by the Parenting Ladder Scale
timeFrame: assess when infants reach 3 month of corrected age
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan University School of Health
name: Chuan-Hua Yu
role: STUDY_CHAIR
References:
Clinical trial NCT03208322: Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults
Official title: Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include all patients receiving at least 1 dose of DCV and ASV at the selected sites during the specified 24 month study period. Included patients will be:

* At least 18 years of age with CHC, Genotype(GT)-1
* Treatment-naïve and treatment-experienced (null or partial) responders
* Intolerant to interferon (IFN)
* With or without cirrhosis

Brief summary: The primary objective of the study is to determine the number of adverse events (AEs) reported by chronic hepatitis C (CHC) patients receiving at least 1 dose of daclatasvir (DCV) and asunaprevir (ASV) at the 2 sentinel sites and that have been reported through the Mexican Health Authority's AE surveillance system during a specified 24-month study period. The secondary objective is to describe AEs reported by CHC patients receiving treatment with DCV and ASV treated by doctors at participating sentinel sites for the National Pharmacovigilance Center (CNFV) in Mexico during a specified 24-month study period.


Eligibility criteria: For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* at least 18 years of age with CHC, GT-1
* treatment-naïve and treatment-experienced (null or partial) responders
* intolerant to interferon (IFN)
* with or without cirrhosis

Exclusion Criteria:

* patients who received DCV and ASV as part of a clinical trial
* patients who received DCV and ASV for any indication other than that which is locally approved
* contraindications included in the approved Mexican prescribing information

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: The number of adverse events (AEs) reported by patients treated with at least one dose of daclatasvir (DCV) and at least one dose of asunaprevir (ASV) and reported to the Health Authority (HA) during a specified period.
timeFrame: 24 months
Secondary outcomes:
measure: The adverse events (AEs) reported to the Health Authority (HA) during a specified period in table format identifying the report number, patient Identification number, and type of adverse event (AE).
timeFrame: 24 months
Other outcomes:
Locations:
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Magdalena De Las Salinas
country: Mexico
facility: Local Institution
state: Distrito Federal
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06581822: Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation
Official title: Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bipolar Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 68
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: Patients diagnosed with bipolar disorder but not yet treated with lithium, where there is a decision by the patient and the responsible doctor to start lithium treatment. Patients are recruited in specialized care.

Brief summary: Previous studies indicate an association between severe psychiatric disorders, such as bipolar disorder, and increased risk of venous thromboembolism. However, to which extent this association is influenced by lithium treatment is currently unknown. In this prospective cohort study, the investigators aim to investigate the effect of bipolar disorder and lithium treatment on coagulation and the counterpart fibrinolysis.

Detailed description: The investigators will analyse differences in coagulation

* using a case-control design where cases are bipolar patients not yet treated with lithium, and controls are healthy volunteers (Swedish ethical review authority Dnr 2023-05799-02, PI Kristoffer Månsson, KI).
* using a prospective cohort design, following the patients over time.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with bipolar disorder but not yet treated with lithium, where there is a decision by the patient and the responsible doctor to start lithium treatment.

Exclusion Criteria:

* Inability to give informed consent

Primary outcomes:
measure: Extracellular vesicles
timeFrame: From enrollment to end of examination at 2 years
measure: Hemostatic potential
timeFrame: From enrollment to end of examination at 2 years
Secondary outcomes:
Other outcomes:
measure: Plasma proteins of coagulation- or fibrinolysis-related processes
timeFrame: From enrollment to end of examination at 2 years
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
Clinical trial NCT01627522: Evaluation of Finastride Effect in Different Dosage on the Amount of Perioperative Bleeding in Transurthral Resection of Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Benign Prostate Hyperplasia
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preoperative use of finastride will decrease the amount of perioperative blood loss during and after TURP

The effect of finastride on decreasing the amount of perioperative blood loss during and after TURP is dose dependent

Finastride will decrease microvascular density in prostate tissue and this effect is dose dependent


Eligibility criteria: Inclusion Criteria:

* Patients with BPH that require TURP

Exclusion Criteria:

* Previous prostate surgery
* Prostate Cancer
* Coagulopathy
* The use of NSAIDs, Anticoagulants, Antiplatelet drugs
* CRF/ESRD

Primary outcomes:
measure: Perioperative Hb Drop
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Faghihi Hospital
state: Fars
Study officials:
References:
citation: Aminsharifi A, Salehi A, Noorafshan A, Aminsharifi A, Alnajar K. Effect of Preoperative Finasteride on the Volume or Length Density of Prostate Vessels, Intraoperative, Postoperative Blood Loss during and after Monopolar Transurethral Resection of Prostate: A Dose Escalation Randomized Clinical Trial Using Stereolog Methods. Urol J. 2016 Mar 5;13(1):2562-8.
Clinical trial NCT03490422: Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors
Official title: Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpitis
Pulp Exposure, Dental
Pulp and Periapical Tissue Disease
Keywords: pulpotomy
permanent teeth
deep caries management
risk factors
clinical indicators for pulpotomy
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 53
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Trial evaluated the extent of pulp survival following pulpotomy in the permanent tooth pulp exposed by caries and identify potential risk factors for pulpal complications.

Detailed description: Healthy patients ≥ 21 years old were recruited with informed consent. Inclusion criteria were symptomatic and asymptomatic periodontally sound teeth, positive response to pulp sensibility tests, pulp exposure by caries with bleeding, haemostasis achieved within 10 minutes and normal apical tissues. Under local anaesthesia and rubber dam isolation, caries was removed before pulpotomy. Pain complaint, clinical and radiographic data were collected during recalls for up to 3 years.

Eligibility criteria: Inclusion Criteria:

Patient factors:

* Male and female at least 21 years of age
* Healthy and ambulant
* Mild diseases only and without substantive functional limitations
* Able to return for scheduled recalls

Tooth factors:

* Deep caries leading to pulp exposure
* With or without pre-operative spontaneous and/or aggravated pain
* Positive response to Cold and Electric Pulp Tests
* Positive bleeding on pulp exposure
* Haemostasis within 10 minutes
* Intact and continuous periodontal ligament space and dental lamina dura on radiograph

Exclusion Criteria:

Patient factors:

* Younger than 21 years of age
* Pregnant female
* Poorly controlled systemic diseases e.g. diabetes mellitus, hypertension

Tooth factors:

* Extensive tooth structure loss requiring post and core retained restoration
* Uncontrolled periodontal disease
* Cracked tooth
* Traumatized tooth
* Haemostasis not achieved within 10 minutes

Primary outcomes:
measure: Change in radiographic apical status
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NUHS
name: Victoria Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References: