louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00673166: Evaluation of Local Mechanisms for Staff Motivation to Reduce Hospital Mortality
Official title: Evaluation of Local Mechanisms for Staff Motivation to Improve Treatment and Reduce Mortality Due to Malaria at the Paediatric Ward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospital Mortality
Malaria
Keywords: Staff motivation
Hospital mortality
Perception of quality of care
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Statens Serum Institut
First posted: 2008-05-07
Enrollment: 900
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We observed in a randomised intervention trial in Bissau that mortality due to malaria could be reduced by half by adding a small monetary incentive to the staff and strict follow-up of a standard protocol for available drugs. The Government and donors are not able to sustain such incentives. We intend to evaluate whether strict organisation of a cost recovery system and the use of part of the funds for staff incentives would improve performance of the staff and contribute to reduction of hospital and post-discharge mortality.

Detailed description: A committee will organise collection and use of the money, and decide on incentives to be paid to the staff based on performance indicators. All children \< 5 years of age admitted to the ward will be registered and followed-up until two months after the consultation. Data on the level of mortality before and after the study period will be collected. Furthermore, interviews on quality perception of the parents will be carried out before and after the study.

Eligibility criteria: Inclusion Criteria:

* Children under five years of age admitted to the ward
* Parents of these children

Primary outcomes:
measure: Overall hospital and malaria mortality
timeFrame: One year
Secondary outcomes:
measure: Parent's perception of the quality of care received
timeFrame: One year
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Paediatric department at the national hospital
Study officials:
affiliation: Bandim Health Project & Gates Malaria Partnership
name: Amabelia Rodrigues, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biai S, Rodrigues A, Gomes M, Ribeiro I, Sodemann M, Alves F, Aaby P. Reduced in-hospital mortality after improved management of children under 5 years admitted to hospital with malaria: randomised trial. BMJ. 2007 Oct 27;335(7625):862. doi: 10.1136/bmj.39345.467813.80. Epub 2007 Oct 22.
citation: Sodemann M, Veirum J, Biai S, Nielsen J, Bale C, Skytte Jakobsen M, Gustafson P, Aaby P. Reduced case fatality among hospitalized children during a war in Guinea-Bissau: a lesson in equity. Acta Paediatr. 2004 Jul;93(7):959-64.
Clinical trial NCT01620866: A Eye Movement Desensitization Reprocessing (EMDR) Study in Bipolar Traumatized Patients
Official title: A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
PTSD
Keywords: EMDR
bipolar disorder
trauma
subsyndromal symptoms
PTSD
Lead sponsor: FIDMAG Germanes Hospitalàries
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR), an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning, quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.


Eligibility criteria: Inclusion Criteria:

* Bipolar I or II disorder following DSM-IV criteria
* Instable, subsyndromal course defined as at evaluation baseline (HAMD \> 8 \< 15 and/or YMRS \> 7 \< 14)
* Good adherence to pharmacological treatment
* Major or minor traumatic life-events
* EMDR therapists \> 3 years experience
* Able to sign informed consent

Exclusion Criteria:

* Major affective episode in last 3 months
* Active drug abuse/dependency
* Neurological disease
* Suicidal thoughts/ideation
* Prior treatment EMDR
* DES \> 25

Primary outcomes:
measure: The primary outcome of this study is a statistically significant reduction in the YMRS and/or HDRS in the EMDR group compared with the TAU group.
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: The EMDR group improves statistically significant in trauma load when compared to TAU.
timeFrame: 3 months and 6 months
measure: The EMDR group improves statistically significant in cognitive tests when compared to TAU.
timeFrame: 3 months and 6 months
measure: The EMDR group improves statistically significant in functioning when compared to TAU.
timeFrame: 3 months and 6 months
measure: The EMDR group improves statistically significant in quality of life when compared to TAU.
timeFrame: 3 months and 6 months
measure: Plasma levels of BDNF was statistically higher in the EMDR group after intervention when compared to TAU.
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: FIDMAG
Study officials:
affiliation: FIDMAG Germanes Hospitalàries
name: Benedikt L Amann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kauer-Sant'Anna M, Tramontina J, Andreazza AC, Cereser K, da Costa S, Santin A, Yatham LN, Kapczinski F. Traumatic life events in bipolar disorder: impact on BDNF levels and psychopathology. Bipolar Disord. 2007 Jun;9 Suppl 1:128-35. doi: 10.1111/j.1399-5618.2007.00478.x.
citation: Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.
Clinical trial NCT00306566: Safety and Immunogenicity of a Melan-A VLP Vaccine in Early Stage Melanoma Patients
Official title: A Phase IIa Study to Evaluate Safety, Tolerability, and Immunogenicity of a Melan-A VLP Vaccine in HLA-A2 Positive Patients With Stage II Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Melanoma
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2006-03-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to monitor a specific cellular immune response in melanoma patients at an early stage of the disease, that have been vaccinated with a Melan-A VLP vaccine.


Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent
* Able and willing to complete all protocol requirements
* Age: 18 years and older
* Histological confirmed stage II melanoma
* HLA-A\*0201 haplotype
* Expected survival of at least 6 months
* ECOG performance status of 0 or 1
* Full recovery from surgery
* Adequate organ and bone marrow functions
* Sexually active males should use adequate contraception throughout the study period and 3 months thereafter.
* Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine.

Exclusion Criteria:

* Pregnant or nursing
* Use of an investigational drug within 30 days before enrolment
* Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ.
* Major surgery within 4 weeks prior to enrollment.
* Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug (e.g. steroids, antihistamine drugs; topical or inhalational steroids are permitted).
* Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders.
* Serum tests positive for HIV, HBV, HCV.
* Active autoimmune diseases or severe allergies.
* Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
* Blood donation or loss of \> 500mL within 8 weeks prior to inclusion.
* Abuse of alcohol or other recreational drugs.
* Previous vaccination with a Melan-A analog peptide.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Pluridisciplinaire d'Oncologie & LICR, CHUV
state: Vaude
Study officials:
affiliation: Centre Pluridisciplinaire d'Oncologie & LICR, CHUV
name: Danielle Lienard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01661166: A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy
Official title: A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Laparoscopic Prostatectomy )
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Adenocarcinoma
Keywords: Male adult subjects
aged 30-90 years
RARP
American Urological Association symptom score greater than 7 will be included
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 3
Sex: MALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will assess the incidence of Overactive Bladder/Detrusor Overactivity (OAB/DO) post-operatively in patients post robotic assisted radical prostatectomy (RARP) and to investigate whether fesoterodine will alter the incidence of OAB/DO in these patients. Additionally, the correlation between OAB symptoms and urodynamic DO will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Men aged 30 to 90 years old with prostate adenocarcinoma who have already made their treatment selection of RARP, and only men with an AUA symptom score greater than 7 will be included. All subjects must be able to read and comprehend fully the informed consent.

Exclusion Criteria:

* Men with prostate neoplasms other than adenocarcinoma
* Subjects receiving other treatments for prostate cancer will be excluded.
* Any subject with a preexisting bladder disease will be excluded.
* Subjects with acute urinary retention and/or deceased gastrointestinal motility.
* Subjects with glaucoma.
* Subjects with hepatic or renal impairment.
* Subjects taking CYP3A4 Inhibitors (e.g.ketoconazole, itraconazole, clarithromycin).
* Subjects with myasthenia gravis
* Subjects who are unwilling or unable to complete the subject questionnaires
* Subjects, who in the opinion of the investigator, would be non-compliant with the majority of the visits scheduled or study procedures.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: David Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01947166: Pancreatic Resection, Malnutrition and Readmission
Official title: Pancreatic Resection, Malnutrition, and Readmission: Assessment and Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Malnutrition
Keywords: Whipple
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Whipple procedure is associated with increased readmission rates for infection, pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop an evidence based perioperative nutrition plan to improve patient outcomes. The study has two specific aims including evaluation of feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a standard perioperative nutritional plan on primary outcome of readmission rate and secondary outcomes of readmission cause, length of stay for initial hospitalization and/or readmission, post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying), and nutritional status (PG-Subject Generated Assessment scores, BMI, albumin, pre-albumin, and method of oral intake). Categorical variables including readmission rate, readmission cause, post-surgical complications and nutritional status will be compared by chi-square test between intervention and control group. Length of stay for initial hospitalization and readmission will be compared by non parametric Wilcoxon test between two groups. Descriptive statistics will be used to describe the sample. There are no risks to the study participants.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years of age)at Duke Cancer Center
* Malignant pancreatic disease, undergoing surgical resection with pancreaticoduodenectomy (Whipple)
* Able to read and speak English.

Exclusion Criteria:

* Patients receiving preoperative enteral nutrition
* Inability to tolerate preoperative oral intake

Primary outcomes:
measure: Feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple as measured by percentage of adherence to nutritional protocol
timeFrame: Up to week 6
measure: Readmission Rate
timeFrame: Up to week 6
Secondary outcomes:
measure: Readmission cause
timeFrame: Up to week 6
measure: Length of stay for initial hospitalization and/or readmission
timeFrame: Up to week 6
measure: Post surgical complications
timeFrame: Up to week 6
measure: Nutritional status
timeFrame: Up to week 6
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Kara L Penne, RN, MSN, ANP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00670566: Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients
Official title: Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-05-02
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the antihypertensive efficacy of a fixed combination of Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive patients.

The secondary objective is to get systolic blood pressure and diastolic blood pressure goal attainment rate from CoAprovel in Chinese hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* Essential hypertensive patients
* Moderate to severe Patients with uncontrolled blood pressure (systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg for untreated, systolic blood pressure ≥150mmHg, diastolic blood pressure ≥95mmHg for treated on monotherapy).
* Patients are willing to discontinue previous antihypertensive medicine

Exclusion Criteria:

* Pregnant or lactating women, or women of child bearing potential without contraceptive method.
* Hypersensitivity to any component of the products or other sulfonamide derived substances.
* Secondary hypertension.
* Severe renal impairment (Creatinine Clearance ≤30ml/min)
* Severe hepatic impairment, biliary cirrhosis and cholestasis.
* Refractory hypokalemia, hypercalcaemia.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of patients with controlled blood pressure
timeFrame: At month 3
Secondary outcomes:
measure: Adverse events
timeFrame: Throughout the study period
measure: Systolic and Diastolic Blood Pressure
timeFrame: At month 3 versus baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Mei Mao
role: STUDY_DIRECTOR
References:
Clinical trial NCT00742066: Role of AT1-receptor Blockers in Insulin-induced Vasodilation.
Official title: Insulin-induced Microvascular Activity in Patients With Essential Hypertension: a Possible Role for Angiotensin II AT1-receptor Blockers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Insulin Resistance
Microcirculation
Keywords: Hypertension
Insulin resistance
Microcirculation
Angiotensin II receptor blocker
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-08-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study we hypothesize that blocking the angiotensin II AT1-receptor improves the insulin-induced microvascular dilatation. Objectives: 1. Does blockade of the angiotensin II AT1-receptor improve the insulin-induced microvascular effects in hypertensive patients. 2. Does blockade of the angiotensin II AT1-receptor impair the insulin-induced microvascular effects in normotensive control subjects?


Eligibility criteria: Inclusion Criteria:

hypertensive subjects:

1. 18-60 years
2. Caucasian
3. untreated hypertension \>140/90mmHg.

normotensive subjects:

1. 18-60 years
2. Caucasian
3. Blood pressure \<140/90 mmHg.

Exclusion Criteria:

1. Obesity (BMI\>27kg/m2)
2. Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
3. Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA
4. Smoking
5. Alcohol use \>4U/day
6. Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)
7. Pregnancy
8. Wearing contact lenses

Primary outcomes:
measure: functional recruitment of capillaries in the skin
timeFrame: July 2009
Secondary outcomes:
measure: perfused capillary density in the nailfold
timeFrame: July 2009
measure: Endothelium- (in)dependent vasodilatation of finger skin microcirculation
timeFrame: July 2009
measure: Density of arterioles, capillaries and venules in the bulbar conjunctiva.
timeFrame: July 2009
measure: Diameter of arterioles and venules in the bulbar conjunctiva
timeFrame: July 2009
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
state: P.O. Box 5800
Study officials:
affiliation: Univeristy Hospital Maastricht
name: CDA Stehouwer, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00092066: A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
Official title: A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Vitamin D Deficiency
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 717
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety, tolerability and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during the treatment of osteoporosis in men and postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Men or postmenopausal women who are osteoporotic

Exclusion Criteria:

* Vitamin D deficiency
* Other disease of bone or mineral metabolism
* Digestive disease causing malabsorption
* Other significant medical conditions that are not adequately treated

Primary outcomes:
measure: Proportion of patients with Vitamin D insufficiency (defined as serum 25-hydroxyvitamin levels <15 ng/mL) after 15 weeks of treatment.
Secondary outcomes:
measure: Proportion of patients with vitamin D deficiency (serum 25-hydroxyvitamin D levels <9 ng/mL) after 15 weeks of treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Recker R, Lips P, Felsenberg D, Lippuner K, Benhamou L, Hawkins F, Delmas PD, Rosen C, Emkey R, Salzmann G, He W, Santora AC. Alendronate with and without cholecalciferol for osteoporosis: results of a 15-week randomized controlled trial. Curr Med Res Opin. 2006 Sep;22(9):1745-55. doi: 10.1185/030079906x120913.