louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00768001: Genetic Analysis of Liver Cancer
Official title: Genetic Analysis of Liver Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Cancer
Hepatitis B
Hepatitis C
Hepatobiliary Cancers
Hepatobiliary Cancers Liver
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-10-07
Enrollment: 41
Sex: MALE
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: liver cancer patients

Brief summary: Liver cancer is a leading cause of cancer deaths worldwide. While the molecular pathogenesis of liver cancer has been extensively studied, less is known about how the molecular biology of liver cancer influences clinical outcome and treatment response. We are developing a translational research program that will characterize molecular changes in liver cancer. We plan to use molecular information obtained from studying liver tumor tissues to develop new diagnostics and treatment regimens for patients with these cancers. The experimental approach will require freezing fresh tumor tissues obtained from surgical procedures, which will be subsequently used for analysis of DNA, protein and mRNA expression. Many patients with liver cancer are referred to the Stanford Liver Tumor Board for consultation and treatment recommendations. We propose to gather tissue samples from those who subsequently undergo biopsy, liver resection surgery, or transplant surgery.


Eligibility criteria: Inclusion Criteria:3.1.1 Male or female patients 18 years of age and above. 3.1.2 Patients diagnosed with liver cancer based on biopsy or serum alpha-fetoprotein level, associated with characteristic hypervascular liver tumors on triphasic spiral CT scan or MRI. Patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia. Patients with metastatic tumor from anther organ, such as metastatic colon cancer.

3.13 Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:3.2.1Female patients who are pregnant or nursing will be excluded from the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Samuel So
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02942901: Clinical Evaluation of PET-CT for Staging of Colorectal Lung Metastases
Official title: Clinical Evaluation of PET-CT for Staging of Colorectal Lung Metastases - a Prospective Monocentric Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: PET-CT
pulmonary metstasectomy
Lead sponsor: Lung Clinic Heckeshorn
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pulmonary metastases eligible for pulmonary metastasectomy

Brief summary: Surgery has been available for the treatment of pulmonary metastases in metastatic colorectal cancer and promising overall survival was observed in retrospective studies with selected patients. This study investigated whether the preoperative FDG- PET/CT scan influences survival in this patient group. Furthermore, we tried to identify other prognostic factors associated with overall survival and progression-free survival.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years with pulmonary metastases eligible for pulmonary metastasectomy

Exclusion Criteria:

* Second primary cancer within the last 2 years (exception basal cell carcinoma of the skin)
* Pregnancy,
* Drug addiction,
* Renal dialysis

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years
Secondary outcomes:
measure: Number and sites of metastases detected by PET-CT
timeFrame: 3 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Lung Clinic Heckeshorn at HELIOS Hospital Emil von Behring
Study officials:
References:
citation: Pastorino U, Veronesi G, Landoni C, Leon M, Picchio M, Solli PG, Leo F, Spaggiari L, Pelosi G, Bellomi M, Fazio F. Fluorodeoxyglucose positron emission tomography improves preoperative staging of resectable lung metastasis. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1906-10. doi: 10.1016/s0022-5223(03)00211-3.
Clinical trial NCT01486901: Bioequivalence of Two Insulatard® Formulations in Healthy Subjects
Official title: A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulatard® (600 Nmol/ml) and Insulatard® (1998 Nmol/ml) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive
* Non-smoker, defined as no nicotine consumption for at least one year
* Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

* Previous participation in this trial or other clinical trials within the last 3 months
* Body weight above 87.5 kg
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant)
* History of alcohol or drug abuse

Primary outcomes:
measure: Area under the serum insulin concentration-time curve (AUC 0-24 hours)
measure: Maximum serum insulin concentration (Cmax)
Secondary outcomes:
measure: Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)
measure: Time to maximum serum insulin concentration (tmax)
measure: Terminal serum insulin half life (t½)
measure: Adverse events
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04010201: A Registered Cohort Study on Brain Calcification
Official title: A Registered Cohort Study on Brain Calcification
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Calcification
Keywords: brain calcification
natural history
genetics
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: Chang Gung Memorial Hospital
First posted: 2019-07-08
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Brain calcification patients who are diagnosed in the First Affiliated Hospital of Fujian Medical University

Brief summary: Brain calcification is a common neuroimaging feature in patients with metabolic, neurological, or developmental disorders, infectious diseases, traumatic or toxic history, as well as in otherwise normal older people. To understand the clinical and genetic characteristics of brain calcification, we establish a cohort of brain calcification to follow up patients with brain calcification.


Eligibility criteria: Inclusion Criteria:

* Patients with brain calcium deposit(s) based on examinations of CT scans
* Patients with total calcification score(TCS) greater than the physiological threshold
* Relatives of brain calcification patients.
* Unrelated healthy controls
* Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

* Brain calcification caused by specific secondary factors such as infection, poisoning, and trauma
* Participants declining or unable to comply with trial procedures and visit schedule

Primary outcomes:
measure: The incidence of hereditary brain calcification
timeFrame: Up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology, First Affiliated Hospital Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT00855101: A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults
Official title: An Open-Label, Intravenous (6/4 Mg/Kg Q12h) To Oral Switch (200 Mg Q12h), Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Healthy Male And Female Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics and safety of voriconazole intravenous oral adults
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to assess the plasma concentration-time profile of voriconazole in adults receiving 7-day intravenous treatment and 6.5-day oral treatment. This study is also to assess the safety profile of voriconazole during the treatment period.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects from 18 and 55 years old.
* Body weight between 40 kg (88 lbs) and 100 kg (220 lbs).

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, ocular, neurologic, or allergic disease.
* Subjects with any condition possibly affecting drug absorption, eg, gastrectomy.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.

Primary outcomes:
measure: The pharmacokinetics of voriconazole following an intravenous to oral switch regimen in healthy adults
timeFrame: 14 days
Secondary outcomes:
measure: The safety and tolerability of voriconazole following an intravenous to oral switch regimen in healthy adults
timeFrame: 14 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00506701: Effect of Tadalafil in Chronic Obstructive Lung Disease Patients Suffering From Secondary Pulmonary Hypertension
Official title: Pilot Study to Investigate the Effect of Tadalafil on Secondary Pulmonary Hypertension in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Obstructive Lung Disease
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2007-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tadalafil may lower the pulmonary artery pressure in patients with Chronic Obstructive Lung Disease and secondary pulmonary hypertension and thereby improve patients quality of life.

Detailed description: Twenty outpatients with Chronic Obstructive Lung Disease (COPD) and secondary pulmonary hypertension are treated in a cross-over design with Tadalafil or placebo for 4 weeks. Primary effect parameter is 6 min. walking test.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Chronic obstructive lung disease

Exclusion Criteria

* Patients with asthma

Primary outcomes:
measure: Change in 6 min. walking test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev University Hospital
Study officials:
affiliation: University of Copenhagen
name: Lars C Laursen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03108001: Glowing and Expecting Follow Up
Official title: Glowing and Expecting Follow Up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 514
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Former Glowing and Expecting study participants aged 5 to 14 years of age.

Brief summary: This study will help us learn more about how a mother's health during pregnancy may influence her child's growth and development later in life.

Detailed description: This study will follow participants who participated in the Glowing and Expecting study. 514 people who are 5 to 14 years of age who agreed to be contacted for future studies will be part of this study.

Eligibility criteria: Inclusion Criteria:

* Former Glowing and Expecting study participants aged 5 to 14 years of age

Exclusion Criteria:

* Participants who were dropped from the Glowing and Expecting studies.

Primary outcomes:
measure: Child's growth and development
timeFrame: up to age 14
measure: Child's metabolism and physical activity
timeFrame: up to age 14
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
References:
Clinical trial NCT00139867: A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease
Official title: A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets, in subjects with stable Parkinson's disease.

Detailed description: See approved Package Insert for Adverse Event information.

Eligibility criteria: Inclusion Criteria:

* Stable Parkinson's Disease

Exclusion Criteria:

* Not using carbidopa/levodopa tablets

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Schwarz
state: Wisconsin
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01831167: Effect of Dynamic Light Application on Performance of ICU Nurses
Official title: Effect of Dynamic Light Application on Performance of ICU Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sustained Selective Attention
Divided Attention
Keywords: dynamic light application
sustained attention
divided attention
nursing
Lead sponsor: Jeroen Bosch Ziekenhuis
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In two sessions of four days nurses will be exposed to dynamic lighting and normal (reference) lighting. Through the psychological tests T.O.D.A. (Test or divided attention) and T.O.S.S.A. (Test of sustained selective attention), then the focus tested. These two tests run both 5 times. The investigators also ask to fill out: 3 questionnaires, fatigue and mood, sleep and Questions of Life.


Eligibility criteria: ICU nurses working 32 hours/week or more

Primary outcomes:
measure: score on Test of Divided Attention
timeFrame: march 2013
measure: Test on Sustained Selective Attention(TOSSA)
timeFrame: to april 2013
Secondary outcomes:
Other outcomes:
Locations:
city: ''s-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
Study officials:
affiliation: Jeroen Bosch Ziekenhuis
name: Koen Simons, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00177567: Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study
Official title: Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Manic Depression
Elderly
Late-Life
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 60
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 collect pilot data on the feasibility of recruiting, eliciting informed consent, assessing, treating, and following patients aged 60 and older with bipolar mood disorders.

Detailed description: Study specific aims are:

* to establish a recruitment, referral, and collaborative network for elderly bipolar patients, in collaboration with the NIMH funded STEP-BD
* to establish an outpatient treatment clinic at the Bellefield Towers site of the NIMH funded Intervention Research Center for Late Life Mood Disorders
* to implement standardized care pathways compatible with STEP-BD treatment algorithms for mood stabilizing pharmacotherapy.
* to document short- and long-term treatment response with respect to affective symptoms, sleep, general life functioning, cognition, treatment-emergent side effects
* to establish the clinical infrastructure necessary for randomized controlled clinical trials and for clinical research training in bipolar mood disorders of late-life.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of Bipolar Disorder
* Folstein Mini-Mental Status Exam score of 18 or higher

Exclusion Criteria:

* Medical condition that precludes the use of both lithium and depakote
* If mood disturbance is deemed an organic mood disorder (i.e., iatrogenic, secondary to medication)
* If refuse to designate someone who the study staff can contact about bipolar symptoms, concerns about the subject's health, in an emergency, and/or inability to reach the subject.

Primary outcomes:
measure: The percent of subjects remitting from their index affective episode, the time to remission, the percent of partially and non-remitting patients, the incidence of relapse during continuation treatment, and of recurrence during maintenance treatment
Secondary outcomes:
measure: Measures of affective symptoms, functional status, side effects, and cognition tracked over acute, continuation, and maintenance phases of treatment.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsubrgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Charles F Reynolds III, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03986567: The "Notijoves" Randomised Controlled
Official title: Impact of New Communication Technologies and Gamification in the Promotion of Partner Notification of Sexually Transmitted Infections Among Young People: The "Notijoves" Randomised Controlled
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sexually Transmitted Diseases
Keywords: Mobile Applications
Contact Tracing
Game Theory
Adolescent
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Català d'Oncologia
First posted: 2019-06-14
Enrollment: 416
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background:

Increase of sexually transmitted infections (STIs) as well as increased use of new information and communication technologies (ICTs) among young people in Catalonia triggers the idea of designing a mobile phone application to promote partner notification.

Objective:

Design a web based tool adapted to Mobile phones for partner notification of STI among youngsters 16 to 24 years old and evaluate its role in increasing the "patient referral" partner notification.

Methods:

This is a multicentre randomised controlled trial with a proportional stratification of the sample by centre and random allocation of participants to the three arms of the study (simple web based intervention, game web based intervention and control). This study is conducted by midwives, gynaecologists and physicians in the sexual and reproductive areas of the primary health care centres.

The study population is: 1- All youngsters 16 to 24 years old diagnosed with one of the three curable STIs, (Syphilis, gonococcus and chlamydia). 2- All partners of those diagnosed with the previous STIs, independently of their state of infection.


Eligibility criteria: Inclusion Criteria:

* 16 to 24 years old diagnosed with one of the three curable STIs, (Syphilis, gonococcus and chlamydia).
* All partners of those diagnosed with the previous STIs, independently of their state of infection.

Exclusion Criteria:

* Already participated in the study within its length

Primary outcomes:
measure: Effectiveness of partner notification: number of partners notified out of number of cases diagnosed
timeFrame: 2 months after diagnose
Secondary outcomes:
measure: yield of early diagnosis and treatment of those exposed and infected;
timeFrame: 3 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Catalan Institute of Health (Ics)
state: Barcelona
Study officials:
affiliation: CATALAN INSTITUTE OF HEALTH (ICS)
name: GEMMA FALGUERA PUIG, PhD
role: PRINCIPAL_INVESTIGATOR
References: