louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03595254: Digital Cognitive Behavior Therapy Program for Suicide Prevention
Official title: Thrive-Montana: A Computerized Cognitive Behavior Therapy (cCBT) Program to Reduce Depression, Anxiety, Suicidal Ideation and Behaviors for Rural Montanans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Depression
Anxiety
Lead sponsor: Montana State University
Sponsor class: OTHER
Collaborators: name: Montana Department of Public Health and Human Services
First posted: 2018-07-23
Enrollment: 725
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized waitlist controlled trial (first ?? participants) Open trial (following ?? participants)
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of Thrive, a computerized cognitive behavior therapy program, to reduce depression and anxiety symptoms and to reduce suicidal thinking among adults. The first 450 participants will participate in a randomized waitlist controlled trial. The remaining 550 participants will be provided the program immediately upon enrolling

Detailed description: The efficacy of Thrive has been studied among patient and community populations and has shown to effectively reduce depression and anxiety symptoms among adults with moderate to severe depression symptoms at baseline.

This study will examine whether Thrive can also reduce suicidal thinking for persons exhibiting at least moderate depression symptoms. The first phase of the study will implement a randomized waitlist controlled trial. The second phase of the study will examine the effects in a open trial. Outcome assessments will occur at baseline, 4- and 8-weeks (12- and 16-weeks for the waitlist group) with a 6-month follow-up assessment for all participants.

Eligibility criteria: Inclusion Criteria:

* Montana resident
* 18+ years old
* Have regular access to broadband internet
* PHQ-9 score greater than 4

Exclusion Criteria:

* No Montana residency
* \< 18 years old
* No broadband internet access
* PHQ-9 score less than 5

Primary outcomes:
measure: Concise Health Risk Tracking
timeFrame: 2 Weeks
Secondary outcomes:
measure: Generalized Anxiety Disorder Scale-7
timeFrame: 2 Weeks
measure: Work and Social Adjustment Scale
timeFrame: 1 Year
measure: Connor-Davidson Resilience Scale - Abbreviated Version
timeFrame: 1 month
measure: Patient Health Questionnaire-9
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Montana State University
state: Montana
Study officials:
References:
Clinical trial NCT01156454: Specimen X-Rays of Removed Axillary Lymph Nodes to Guide Pathological Sampling
Official title: Specimen X-Rays of Removed Axillary Lymph Nodes to Guide Pathological Sampling (GPS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: sentinel lymph node dissection
radiology
X-ray identification of nodes in a surgical specimen
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Tenenbaum Family Foundation
First posted: 2010-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males or females of all races and ethnicities, must be equal to or greater than 18 years of age, scheduled for breast cancer surgery that includes sentinel node biopsy and/or axillary dissection

Brief summary: X-ray mapping of sentinel lymph nodes and/or axillary tissue will assist pathologists in their ability to identify the number and location of lymph nodes as well as more accurately section lymph nodes contained in surgical specimens.


Eligibility criteria: Inclusion Criteria:

Males or females of all races and ethnicities

* ≥ 18 years of age
* Must be scheduled for breast cancer surgery which includes a sentinel lymph node biopsy and/or axillary dissection

Exclusion Criteria:

• Any person whose final pathology could be compromised in any way by the X-ray procedure

Primary outcomes:
measure: Identification of lymph nodes
timeFrame: Within the first 30 minutes after specimen is removed from the body
measure: Identification of affected area in node
timeFrame: Within the first 30 minutes after specimen is removed from the body
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: UAMS
name: V. Suzanne Klimberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson CB, Korourian S, Badgwell BD, Fincher RL, Dell CM, Don Bice C, Boneti C, Westbrook KC, Klimberg VS. Sensitivity of axillary specimen x-ray to predict nodal count and positivity. Ann Surg Oncol. 2011 Oct;18(11):3181-6. doi: 10.1245/s10434-011-1959-x. Epub 2011 Aug 23.
Clinical trial NCT01126554: ICG- Liver Test Versus New Biomarkers as Prognostic Markers in Critically Ill Patients
Official title: ICG- Liver Test Versus New Biomarkers as Prognostic Markers in Critically Ill
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Keywords: Prognostic value
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Brahms AG
First posted: 2010-05-19
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients of a 10 bed ICU unit

Brief summary: Comparison of ICG liver testing with copeptin and SAPS II score as prognostic markers in critically ill patients.

Detailed description: Comparison of different marker for length of stay in the ICU in critically ill patients.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the ICU

Exclusion Criteria:

* Not able to understand German

Primary outcomes:
measure: prolonged length of stay in the ICU (pLOS) more than 3 days
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Surgical ICU, University Hospital Zurich
Study officials:
affiliation: CIM
name: Markus Béchir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zoller B, Spanaus K, Gerster R, Fasshauer M, Stehberger PA, Klinzing S, Vergopoulos A, von Eckardstein A, Bechir M. ICG-liver test versus new biomarkers as prognostic markers for prolonged length of stay in critically ill patients - a prospective study of accuracy for prediction of length of stay in the ICU. Ann Intensive Care. 2014 Jul 8;4:19. doi: 10.1186/s13613-014-0019-7. eCollection 2014.
Clinical trial NCT00905554: Warm Water for Unsedated Colonoscopy
Official title: Warm Water Irrigation Versus Standard Air Insufflation for Unsedated Colonoscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: sedation
warm water
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2009-05-20
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation.


Eligibility criteria: Inclusion Criteria:

* adult outpatients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

* refuse to initiate colonoscopy without routine sedation
* inadequate bowel preparation
* incapacity to give informed consent

Primary outcomes:
measure: Number of Patients Undergoing Complete Unsedated Colonoscopy
timeFrame: 6-9 months
Secondary outcomes:
measure: Evaluation of Pain and Tolerability Scores
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Como
country: Italy
facility: Valduce Hospital
state: CO
Study officials:
References:
citation: Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
Clinical trial NCT05151354: Attachment, Patient Self-disclosure and Psychotherapy Outcome
Official title: Attachment as a Moderator of the Relationship Between Patient Self-disclosure and Psychotherapy Outcome: Separating Within- From Between-patient Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychotherapy
Attachment
Self Disclosure
Treatment Outcome
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 1500
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: The study population consists of patients undergoing inpatient treatment at the university hospital Heidelberg.

Brief summary: This study investigates whether within- and between-patient effects of attachment moderate the association between self-disclosure and psychotherapy outcome.

Detailed description: Participants are recruited at the University Clinic Heidelberg at the beginning of their (usually) 8-week inpatient treatment. After informed consent, patients routinely fill out weekly questionnaires on attachment, self-disclosure, and symptom severity.

This study is the first to disentangle stable, trait-like (between-person) effects of both attachment and self-disclosure from within-person changes over the course of treatment. The study investigates whether (changes in) attachment moderate the association between (changes in) self-disclosure and psychotherapy outcome.

Eligibility criteria: Inclusion Criteria:

* patients of at least 18 years of age
* treated at the inpatient unit of a hospital for psychosomatic medicine
* provided measurements of symptoms, attachment style, and self-disclosure for at least one measurement occasion

Exclusion Criteria:

* bipolar, acute psychotic or substance abuse disorders

Primary outcomes:
measure: Symptom Checklist Short Form (SCL-K11)
timeFrame: for each participant: weekly assessment for 8 weeks of inpatient psychotherapy. Data will be reported for 7 years of continous study enrollment (2014 - 2021)
Secondary outcomes:
measure: Relationship Questionnaire 2 (RQ-2)
timeFrame: for each participant: weekly assessment for 8 weeks of inpatient psychotherapy. Data will be reported for 7 years of continous study enrollment (2014 - 2021)
measure: Inpatient and day clinic experiences questionnaire (IDES)
timeFrame: for each participant: weekly assessment for 8 weeks of inpatient psychotherapy. Data will be reported for 7 years of continous study enrollment (2014 - 2021)
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Heidelberg
name: Ulrike Dinger, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02800954: Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma
Official title: Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
bone lesions
Macrophage-Colony Stimulating Factor
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The Primary objective of this study is to compare serum levels of Macrophage-Colony Stimulating Factor (M-CSF) in a population of patients with multiple myeloma (MM), in a population of patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and in a control population.


Eligibility criteria: Inclusion Criteria:

For the multiple myeloma group

* confirmed diagnosis of de novo multiple myeloma according to the International Myeloma Working Group criteria
* bisphosphonate therapy for more than 60 days,
* signature of the informed consent form,
* patients over the age of 18 years. For the monoclonal gammopathy of undetermined significance (MGUS) group
* confirmed diagnosis of MGUS according to the International Myeloma Working Group criteria
* signature of the informed consent form,
* patients over the age of 18 years. For the healthy control group
* signature of the informed consent form,
* subjects over the age of 18 years.

Exclusion Criteria:

* patients with thyroid or parathyroid disease,
* osteomalacia, rheumatoid arthritis, Paget's disease, osteoporosis,
* bisphosphonate therapy for less than 60 days,
* absence of informed consent,
* patients under the age of 18 years.

Primary outcomes:
measure: Serum Macrophage-Colony Stimulating Factor (M-CSF) levels
timeFrame: Day 1
Secondary outcomes:
measure: Tumour osteolysis
timeFrame: Day 1
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Beauvais
country: France
facility: CH Beauvais
city: Saint Quentin
country: France
facility: Ch Saint Quentin
Study officials:
affiliation: CHU Amiens
name: Valéry SALLE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00172354: Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest
Official title: Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Arrest
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Out-of-hospital cardiac arrest (OHCA) is an important issue for the emergency physicians and co-workers. How to improve the return of spontaneous circulation (ROSC) rate and prognosis of these patients challenges the emergency team. When encounters stress, the hypothalamus of human releases corticotropin releasing hormone, which in turn stimulates the pituitary gland to release ACTH. Then ACTH acts on the adrenal gland to release glucocorticoid to against stress. Foley PJ et al found the dogs with bilateral adrenalectomy had lower ROSC rate during resuscitation than those without surgery\[1\]. Karl H. Linder et al showed OHCA patients had high serum vasopressin and ACTH level but low serum cortisol level. Besides, the serum cortisol level had a negative correlation with collapse duration (no CPR duration)\[2\]. Studies also revealed the successfully resuscitated patients had higher serum ACTH and cortisol level than non-resuscitated ones\[2,3\]. In addition, the serum cortisol level was found to be correlated with short term survival rate and hemodynamic status in resuscitated OHCA patients\[3\]. Animal study also showed mice receiving higher dosage of hydrocortisone had higher ROSC rate and lower epinephrine requirement than those receiving lower dosage of hydrocortisone or normal saline.

\<Reference\>

1. Foley PJ, Tacker WA, Wortsman J, Frank S, Cryer PE.;" Plasma catecholamine and serum cortisol responses to experimental cardiac arrest in dogs."Am J Physiol 1987;253:E283-9
2. Lindner KH, Strohmenger HU, Ensinger H, Hetzel WD, Ahnefeld FW, Georgieff M.;" Stress hormone response during and after cardiopulmonary resuscitation."Anesthesiology 1992;77:662-8
3. Schultz CH, Rivers EP, Feldkamp CS, Goad EG, Smithline HA, Martin GB, Fath JJ, Wortsman J, Nowak RM.;"A characterization of hypothalamic-pituitary-adrenal axis function during and after human cardiac arrest."Crit Care Med 1993;21:1339-47
4. Smithline H, Rivers E, Appleton T, Nowak R.;"Corticosteroid supplementation during cardiac arrest in rats."Resuscitation 1993;25:257-64


Eligibility criteria: Inclusion Criteria:

* Out-of-hospital cardiac arrest

Exclusion Criteria:

* pregnancy
* younger than 18 years old
* trauma
* concurrent steroid use
* ECMO use in resuscitation
* allergy to steroid

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Chiarman of NTUH emergency department
name: Wen-Jone Chen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05763654: PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascular and DFU
Official title: Multicenter, Long-term, Single-arm and Observational PMCF Study on the Safety of Linovera Emulsion for the Prevention of Stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers (PRELINEM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pressure Ulcer
Lead sponsor: B. Braun Medical SA
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Already described in Inclusion and Exclusion criteria

Brief summary: To assess the safety of Linovera® Emulsion in the prevention of Grade I Pressure ulcers, Vascular and Diabetic Foot Ulcers.

To assess the performance of Linovera® Emulsion for the prevention of stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers.

Detailed description: Diverse parameters are to be used to assess the safety and efficacy of Linovera® Emulsion for the prevention of stage 1 pressure ulcer, vascular and diabetic foot ulcers.

This study is designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity as a part of our Post Market Surveillance (PMS).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Signed informed consent
* Patients with the possibility to participate during up 6 month follow-up.
* At least one of these criteria:
* Patients with medium, high or very high risk of amputation due to a vascular or diabetic foot illness.
* Patients with medium, high or very high risk of developing a pressure ulcer due to any neuropathic foot pathology
* Patients with medium, high or very high risk of developing a pressure ulcer following Braden Scale.

Exclusion Criteria:

* Age \< 18 years
* Known allergies and/or hypersensitivity to any component of Linovera® Emulsion.
* Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures.
* Patients in the terminal stage or receiving chemotherapy.
* Patients with more than 3 active pressure ulcers.

Primary outcomes:
measure: Number of adverse events
timeFrame: 1 month
Secondary outcomes:
measure: Number of participant developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers
timeFrame: 1 month
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
Study officials:
References:
Clinical trial NCT01221454: Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure
Official title: Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Failure Resulting From Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Failure
Keywords: ABMSC
Allogenic bone marrow mesenchymal stem cells
Liver Failure
Transplantation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver failure caused by hepatitis B infection. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores, MELD scores and clinical symptoms were also observed simultaneously.


Eligibility criteria: Inclusion Criteria:

* Aged 16\~65 years.
* Serum HBsAg positive for over six months.
* Meet the diagnostic criteria of liver failure:

Exclusion Criteria:

* History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
* Prothrombin time is over 30s.
* Cirrhosis caused by other reasons except HBV infection.
* Severe problems in other vital organs(e.g.the heart,renal or lungs).
* Liver tumor on ultrasonography, CT or MRI examination.
* Pregnant or lactating women.
* Imaging evidences of vascular thromboses.

Primary outcomes:
measure: Liver Function
timeFrame: 12 months
Secondary outcomes:
measure: Immune function
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00619554: A Study on the Intraject Instructions for Use
Official title: Zogenix Intraject Instructions for Use Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers from the community

Brief summary: This study is designed to create an instruction set simple enough to be understood by migraine subjects as they were experiencing miagraine attacks.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Written Informed Consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: