louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00073632: Acceptance-Based Treatment for Generalized Anxiety Disorder
Official title: Developing a New Therapy for GAD: Acceptance-Based CBT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anxiety Disorders
Generalized Anxiety Disorder
Lead sponsor: University of Massachusetts, Boston
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-12-03
Enrollment: 50
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: This study will develop and implement an awareness- and acceptance-based for treatment of individuals with generalized anxiety disorder.

Detailed description: Participants in this study are recruited from intakes at the Center for Anxiety and Related Disorders at Boston University. Participants will be randomly assigned to receive either acceptance and mindfulness-based strategies plus cognitive behavioral therapy or no treatment for 16 weeks. The treatment will involve daily practice of mindfulness techniques to help draw attention to and accept various emotional states. Interviews, questionnaires, and depression and anxiety scales will be used to assess participants. Assessments will be conducted post-treatment and at 3- and 9-month follow-up visits.

Eligibility criteria: Inclusion Criteria:

* Generalized Anxiety Disorder (GAD)
* Willing to maintain medication levels and refrain from any additional psychosocial treatment during the course of the study

Exclusion Criteria:

* Bipolar disorder, psychotic disorder, or substance dependence

Primary outcomes:
measure: Clinician Severity Rating from ADIS for GAD
timeFrame: pre, post, 3 mo. f/u, 9 mo. f/u
measure: Penn State Worry Questionnaire
timeFrame: pre-, post-, 3 mo. f/u, 9 mo. f/u
measure: Depression Anxiety and Stress Scales, anxiety and stress subscales
timeFrame: pre-, post-, 3 mo. f/u, 9 mo. f/u
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Anxiety and Related Disorders
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Boston
name: Lizabeth Roemer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Susan M Orsillo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roemer L, Orsillo SM. An open trial of an acceptance-based behavior therapy for generalized anxiety disorder. Behav Ther. 2007 Mar;38(1):72-85. doi: 10.1016/j.beth.2006.04.004. Epub 2006 Oct 24.
Clinical trial NCT05467332: Tracheal Positive Pressure During High Flow Nasal Oxygen Administration in Critically Ill Patients: a Physiologic Study.
Official title: Invasive Measurement of Positive Tracheal Pressure Generated by High Flow Nasal Oxygen Administration in Critically Ill Patients After Extubation: a Physiologic Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Failure
High Flow Nasal Cannula
Critically Ill
Airway Disease
Positive End Expiratory Pressure
Diaphragm Disease
Keywords: intensive care unit, critically ill patient, high flow nasal cannula, PEEP, respiratory failure, non invasive ventilation
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CRITICALLY ILL PATIENTS REQUIRING INVASIVE MECHANICAL VENTILATION FOR AT LEAST 72 HOURS AND READY FOR EXTUBATION.

Brief summary: High flow nasal cannula administration in critically ill patients is frequently used to improve acute respiratory failure or to prevent respiratory failure after extubation.

It acts generating a mild positive pressure in the airways and by reducing respiratory effort of patients.

However to the best of our knowledge, no study to date has directly measured the amount of positive pressure generated in the trachea of patients.

The primary aim, therefore, of this study measures this positive pressure after extubation in critically ill patients.


Eligibility criteria: Inclusion Criteria: CRITICALLY ILL PATIENTS AFTER MECHANICAL VENTILATION LASTED AT LEAST 72 HOURS

* age 18-80 years

Exclusion Criteria:

* COPD stage \>1 according to GOLD classification
* end stage organ disease (liver, kidney, heart, lung)
* neuromuscular disease
* neoplasm
* previous tracheostomy
* obesity with BMI \> 35 Kg/m2
* non collaborative patient

Primary outcomes:
measure: HFNC-PEEP
timeFrame: 3 HOURS
Secondary outcomes:
measure: HFNC-EADI
timeFrame: 3 HOURS
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Cristian Deana
Study officials:
affiliation: Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy
name: Cristian Deana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01530932: Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin
Official title: Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sepsis
tissue oxygenation
tissue perfusion
immune reaction
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sepsis of pulmonary or abdominal origin with admission to the ICU in the first 48 hours of sepsis onset

Brief summary: Sepsis remains a common entity in critical care patients with remarkable mortality. Pulmonary and abdominal infections (with subsequent sepsis) are the most common in the ICU. Despite extended research activities, no differences in patient outcome or organ dysfunction were revealed.

Sepsis is a complex immune reaction phenomenon based on unbalanced activation and suppression. In addition to changes of cytokine levels and immune cell activity, underlying genetic reactions are present. For instance, expression of miRNA (as a potential important step of immune cell activation) is likely changed during systemic and local immune reactions.

The aim of this study is to perform a detailed assay of immune cell activation, to investigate the levels of pro- and antiinflammatory cytokines and the various expression of miRNA depending on the origin of infection in the two most common sides. This means in ICU patients with early pulmonary or abdominal sepsis as well as in healthy controls. Additionally, clinical parameters of organ function, current infection markers as CRP and procalcitonin, cardiovascular function and heart rate variability will be assessed. Parameters of local tissue perfusion in a dynamic testing during forearm ischemia and plasma adenosine concentration will be measured.


Eligibility criteria: Inclusion Criteria:

* sepsis (according to the criteria of the International Sepsis Definition Conference)

Exclusion Criteria:

* pregnancy
* malignancy
* corticoid therapy
* organ transplantation
* renal insufficiency with HD

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Hospital Mannheim
Study officials:
References:
citation: Sturm T, Leiblein J, Clauss C, Erles E, Thiel M. Bedside determination of microcirculatory oxygen delivery and uptake: a prospective observational clinical study for proof of principle. Sci Rep. 2021 Dec 31;11(1):24516. doi: 10.1038/s41598-021-03922-4.
citation: Sturm T, Leiblein J, Schneider-Lindner V, Kirschning T, Thiel M. Association of Microcirculation, Macrocirculation, and Severity of Illness in Septic Shock: A Prospective Observational Study to Identify Microcirculatory Targets Potentially Suitable for Guidance of Hemodynamic Therapy. J Intensive Care Med. 2018 Apr;33(4):256-266. doi: 10.1177/0885066616671689. Epub 2016 Sep 29.
Clinical trial NCT01178632: Therapeutic Effect of an Herbal Medicine on Anxiety
Official title: A Double-blind, Randomized, Controlled, Phase III Study of an Herbal Medicine Association for Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anxiety Disorders
Keywords: Herbal
Phytotherapy
Passiflora
Valeriana
Anxiety
Lead sponsor: Millet Roux
Sponsor class: INDUSTRY
First posted: 2010-08-10
Enrollment: 136
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: Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit.

Detailed description: The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks.

The improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A).

Does the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of generalized anxiety disorder
* HAM-A scale \> 17 and \<30

Exclusion Criteria:

* HAM-A scale \> 30
* Psychotherapy

Primary outcomes:
measure: Hamilton anxiety scale score
timeFrame: Four weeks
Secondary outcomes:
measure: Insomnia gravity index
timeFrame: Four weeks
measure: Clinical global impression rate scale and Patient global evaluation rate scale
timeFrame: Four weeks
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Clinical Pharmacology Unit - Unifac
state: Ceara
Study officials:
affiliation: CLINICAL PHARMACOLOGY UNIT - UNIFAC
name: MARIA ELISABETE A MORAES, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00765232: Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy
Official title: The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy: a Double Blinded Randomized Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nephrectomy
Laparoscopic Donor Nephrectomy
Keywords: laparoscopic
donor
nephrectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 111
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 study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having laparoscopic surgery to donate a kidney.


Eligibility criteria: Inclusion Criteria:

* Patients donating a kidney via laparoscopic donor nephrectomy

Exclusion Criteria:

* History of NSAID allergy
* Asthma
* History of long term opioid use
* Intraoperative blood loss greater than 300 mL
* Postoperative hemodynamic instability
* Active peptic ulcer disease
* Advanced renal impairment (Cr \> 2.0 mg/dL)
* Bleeding diathesis
* Current use of probenecid
* Pregnancy

Primary outcomes:
measure: Pain 'Right Now'
timeFrame: 24 hours after the end of surgery
measure: Morphine Equivalents of Concomitant Pain Medication
timeFrame: 24 hours after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Mitchell R. Humphreys, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grimsby GM, Andrews PE, Castle EP, Nunez R, Mihalik LA, Chang YH, Humphreys MR. Long-term renal function after donor nephrectomy: secondary follow-up analysis of the randomized trial of ketorolac vs placebo. Urology. 2014 Jul;84(1):78-81. doi: 10.1016/j.urology.2014.04.009.
citation: Grimsby GM, Conley SP, Trentman TL, Castle EP, Andrews PE, Mihalik LA, Hentz JG, Humphreys MR. A double-blind randomized controlled trial of continuous intravenous Ketorolac vs placebo for adjuvant pain control after renal surgery. Mayo Clin Proc. 2012 Nov;87(11):1089-97. doi: 10.1016/j.mayocp.2012.07.018. Epub 2012 Oct 8.
Clinical trial NCT01702337: Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine
Official title: Additional Health and Economic Impact of the Bivalent Versus the Quadrivalent HPV Vaccine in Taiwan: Results of a Prevalence-based Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infection
Keywords: Gardasil
Prevalence-model
Cervarix
economic
health
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypothetical group of women vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan.

Brief summary: This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and the quadrivalent HPV vaccine (HPV-2).

Detailed description: This study uses a prevalence-based model (by using efficacy data from each vaccine's respective trials and published cost data for Taiwan) which estimates the differences in lesions, genital warts, cervical cancer and costs from a healthcare payer's perspective prevented between HPV-1 and HPV-2 vaccines during one year (when all women are vaccinated). It also analyses costs from a societal perspective.

Eligibility criteria: Inclusion Criteria:

* Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group).

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: Annual number of lesions prevented by each vaccine
timeFrame: Over a one-year period
measure: Lesion related total cost averted by each vaccine
timeFrame: Over a one-year period
measure: Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine
timeFrame: Over a one-year period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: ADDITIONAL HEALTH AND ECONOMIC IMPACT OF THE BIVALENT VERSUS THE QUADRIVALENT HPV VACCINE IN TAIWAN: RESULTS OF A PREVALENCE-BASED MODEL, Ho. T.H., van Enckevort, P.J. & Demarteau, N. Poster presented at: ISPOR, 4th Asia-Pacific Conference, 5-7 September 2010, Phuket, Thailand.
Clinical trial NCT03847337: Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism
Official title: Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Developmental Delay
Keywords: telemedicine
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-02-20
Enrollment: 144
Sex: ALL
Minimum age (years): 15
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the investigators are trying to find new ways to screen for autism spectrum disorder (ASD) in young children. The investigators want to see if people like pediatricians can screen children for ASD while a psychologist watches on a monitor. The investigators are testing two screening tools. The investigators want to see if they are good at identifying children with ASD and children without ASD. The investigators hope this research will make it easier for families to get answers when there are concerns for ASD.

Detailed description: The investigators will evaluate and compare two telemedicine assessment tools (TELE-STAT and TELE-ASD-PEDS) that could allow parents or naive providers in remote locations to complete an Autism Spectrum Disorder (ASD) risk assessment via telemedicine consultation via an expert psychologist. These tools will be low cost, compliant with privacy rules, easily deployed in community practice settings, and explicitly designed to work within paradigms that may be pragmatically and financially viable for systems of care housing remote clinicians. These telemedicine tools could provide methodologies wherein children could be rapidly linked to and appropriately assessed by ASD experts within practice locations where the children are currently receiving care. In turn, these children, who without such assessment may wait months or over a year in many circumstances to access assessments and interventions, may be able to receive appropriate ASD assessments within days or weeks of screening/surveillance concerns within practice settings where the children are already accessing and familiar with (i.e., minimizing loss to referral and follow-up)

Eligibility criteria: Inclusion Criteria:

* Children who have been diagnosed with autism or developmental delay

Exclusion Criteria:

* Children with genetic disorders
* Children with medical complexities, such as blindness or deafness
* Children whose families do not speak English

Primary outcomes:
measure: Accurate Diagnosis of Autism Via Telemedicine
timeFrame: 1 day
measure: Accurate Diagnosis of Developmental Delay Via Telemedicine
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Zachary E Warren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00095537: BMS-599626 in Patients With Advanced Solid Malignancies
Official title: Phase I Study of BMS-599626 in Patients With Advanced Solid Malignancies, Including Malignancies That Express HER2 at the Maximum Tolerated Dose and/or Recommended Phase II Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Metastases
Keywords: Solid tumors
cancer
HER-2-expressing tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2004-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to identify the highest oral dose of BMS-599626, a drug that is directed against EGFR and HER2 proteins, that can be given safely on a daily schedule of 21 days with a 7 day rest period in patients with cancer who no longer benefit from other commonly used treatments. The study will also test for other proteins that may be affected by BMS-599626; and the level of study drug in the blood will be studied.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of metastatic cancer that has progressed on currently available therapies;
* At least 3 month life expectancy;
* Primary cancer must be solid (non-hematologic);
* Adequate bone marrow, liver \& kidney function;
* Negative pregnancy test.

Exclusion Criteria:

* Serious, uncontrolled medical disorder;
* Individuals not willing or able to use an acceptable method to avoid pregnancy for the entire study period and for at least 3 months after the study;
* Pregnant or breastfeeding women;
* Patients with known brain metastasis;
* Uncontrolled or significant cardiovascular disease;
* Anticancer therapy within 2-6 weeks prior to study drug (depending on the therapy)

Primary outcomes:
measure: Det. the max tolerated dose,biologically active doses & recommended phase 2 dose of BMS-599626 when adm. as a daily oral dose to pts with HER2 expressing-metastatic solid tumors who have progressed on or following standard therapy
Secondary outcomes:
measure: Evaluate the effect of BMS-599626 on biomarkers & predictive markers of HER1/2 in skin metabolic act. through PET imaging & preliminary evidence of anti-tumor act.,determine the effect of gastric acid modifying agents on systemic exposure of BMS-599626
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Local Institution
state: Arizona
city: Tucson
country: United States
facility: Local Institution
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution
state: California
Study officials:
References:
Clinical trial NCT00338637: Measuring the Balance Improvement on Multiple Sclerosis Patients After a Short Training Period With an APOS (All Phase Of Step Cycle) Kit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Sclerosis
Balance
Cerebelar Impairment
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-06-20
Enrollment: 30
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: Randomised double blind study of two parallel groups,one of the groups trained with the full APOS kit (a shoe with an additional bio mechanical device)

The control group trained with the Apos shoe without the bio mechanical device. both groups will be checked at the beginning of the study, one month later and at the end of the study after two months. The tests include neurological test, functional test(FSST,up and go test and berg balance test) gate analysis and quality fo life (rays) test.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Multiple sclerosis Cerebellar impairment EDSS under 4.5 age 18-65 years signed informed consent form

Exclusion Criteria:

* pregnancy
* coronary event in last 6 month
* 30 days or less after acute attack
* steroidal treatment in the last 60 days
* alcohol abuse

Primary outcomes:
measure: functional tests
Secondary outcomes:
measure: gait analysis
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Anat Achiron, Prof.
role: PRINCIPAL_INVESTIGATOR
References: