louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01002456: Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison
Official title: Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Adrenergic beta-Antagonists
Guideline Adherence
Drug Prescriptions
target dose
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-10-27
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall objective of the proposed pilot study is to begin evaluation of two methods for promoting adherence to guidelines for beta-blocker therapy in heart failure. The design includes site level baseline measurement, feedback, remeasurement after six months, and randomized (by site) comparison samples. The setting is VA sites, with intervention directed at the pharmacy.

Detailed description: Current evidence-based guidelines in VA recommend one of three beta-blockers (carvedilol, metoprolol succinate, or bisoprolol) that have been shown to reduce mortality in heart failure patients with systolic dysfunction, with recommended target doses. However, Pharmacy Benefits Management (PBM) data indicate that prescribing for beta-blockers in heart failure patients that is not in accordance with guidelines is substantial, both in terms of the agent selected and the dose. Sites will be recruited and randomized to two different intensities of intervention to promote adherence to guidelines.

Eligibility criteria: Inclusion Criteria:

* VA sites
* Males and females

Exclusion Criteria:

none

Primary outcomes:
measure: Rate of Adherence to Guideline Prescription
timeFrame: 6 months
Secondary outcomes:
measure: Progress Toward Adherence to Guideline Prescription
timeFrame: 6 months
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: Madeline McCarren, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06864156: Evaluation of MicroRNAs and Vitamin B12 Expression in Subjects with Neurologic Symptoms of Depression, Anxiety and Fatigue in Long COVID-19
Official title: Evaluation of MicroRNAs and Vitamin B12 Expression in Subjects with Neurologic Symptoms of Depression, Anxiety and Fatigue in Long COVID-19
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Long COVID
Long COVID Syndrome
Keywords: anxiety
depression
fatigue
microRNAs
vitamin b12
long covid
Lead sponsor: Instituto Nacional de Rehabilitacion
Sponsor class: OTHER_GOV
First posted: 2025-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with symptoms of depression, anxiety and fatigue after having had COVID-19

Brief summary: At the moment, the number of people with long COVID is unkown because there is still no effective diagnosis. This is why is very important to analyze the most common symptoms, which are: depression, anxiety and fatigue. This project seeks to analyze some blood components of people with long COVID, such as microRNAs and vitamin B12, in order to identify the body processes that changed after COVID-19 and thereby design better therapies and diagnostic methods focused on each of them.

The hypothesis is that the expression of miR-21, -146a and -155 will be overexpressed as well as there will be a deficiency of vitamin B12 in serum in subjects suffering from long COVID with neurological symptoms of depression, anxiety and fatigue.


Eligibility criteria: Inclusion Criteria:

* Subjects with confirmed diagnosis of COVID-19 by SARS-CoV-2 infection by PCR or antigen testing.
* With presence of neurological symptoms of depression, anxiety and fatigue associated with COVID-19 after three months from the first day of acute infection symptoms.

Exclusion Criteria:

* Subjects who have presented symptoms of acute infection in the last twelve weeks.
* Subjects who present diagnostic premorbid neurological alterations.
* Subjects who do not have at least 2 doses of COVID-19 vaccine, with last application date equal or older than 3 months.

Primary outcomes:
measure: Change of microRNA expression between long COVID group and control group
timeFrame: immediately after the blood extraction
measure: Change of vitamin B12 concentration between long COVID group and control group
timeFrame: immediately after the blood extraction
measure: Link the expression of microRNAs with the score obtained in the instruments to evaluate depression, anxiety and fatigue
timeFrame: immediately after the blood extraction
measure: Link the concentration of vitamin B23 with the score obtained in the instruments to evaluate depression, anxiety and fatigue.
timeFrame: immediately after the blood extraction
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Instituto Nacional de Rehabilitación
Study officials:
References:
Clinical trial NCT02552056: The Effect of Integrating CAMH Into PHC and Traditional Healers' Practice in Uganda: a Randomized Controlled Trial
Official title: The Effect of Integrating Child and Adolescent Mental Health Into Primary Health Care and Traditional Healers' Practice: a Randomized Controlled Trial in Eastern Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Mental Health Services
Keywords: Child Adolescent Mental Integration PHC Traditional Healers
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This randomized controlled trial will compare the effect of a CAMH integration package on yield of CAMH cases compared to non-CAMH integrated sites. It will be conducted among nurses, midwives and clinical officers who provide PHC services to children and adolescents in 42 health centers; and eligible traditional healers.

Detailed description: The overall goal of the study is to increase access to mental health services for children and adolescents in Uganda by improving entry through primary health care workers and traditional healers.

The main objective of the study is to measure the effect of integrating child and adolescent mental health (CAMH) into primary health care (PHC) and into traditional healers' services on CAMH case identification in 2 districts in Eastern Uganda, so as to improve entry into mental health services.

The specific objectives are:

1. To estimate the effect of CAMH integration into PHC on case identification, measured by the number of new non- epilepsy CAMH diagnoses.
2. To assess the feasibility and effect of integrating CAMH into traditional healers practice, measured by the number of CAMH referrals from community to clinics per month.
3. To assess the acceptability of CAMH integration among PHC workers and traditional healers
4. To estimate the costs associated with the integration of CAMH into PHC and traditional medicine

Eligibility criteria: Inclusion Criteria:

* 1. Public (government health system) 2. No psychiatric nurse allocated

Exclusion Criteria:

* mhGAP training in the previous 3 years

Primary outcomes:
measure: Proportion of clinics which recorded at least one non-epilepsy CAMH diagnosis in the intervention compared to the control group.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Change in CAMH knowledge pre-and post-training
timeFrame: 5 days
Locations:
Study officials:
References:
citation: Akol A, Makumbi F, Babirye JN, Nalugya JS, Nshemereirwe S, Engebretsen IMS. Does mhGAP training of primary health care providers improve the identification of child- and adolescent mental, neurological or substance use disorders? Results from a randomized controlled trial in Uganda. Glob Ment Health (Camb). 2018 Sep 10;5:e29. doi: 10.1017/gmh.2018.18. eCollection 2018.
Clinical trial NCT06247956: Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer
Official title: A Randomized, Open, Multicenter Phase II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the First-line Treatment of Advanced Gastric and Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced Gastric Adenocarcinoma and Esophageal Squamous Cell Carcinoma
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Objective response rate (ORR) was evaluated to evaluate the efficacy of SHR-8068 combined with adebrelimab and platinum-containing chemotherapy in first-line treatment of advanced gastric and esophageal cancer.


Eligibility criteria: Inclusion Criteria:

1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
2. Aged 18-75 at the time of signing the informed consent;
3. Histologically or cytologically confirmed, unresectable, advanced or recurrent/metastatic adenocarcinoma of the gastric or gastroesophageal junction, or unresectable or recurrent/metastatic esophageal squamous cell carcinoma without radical chemoradiation;
4. At least one measurable lesion consistent with RECIST v1.1;
5. ECOG PS score: 0-1;
6. The organ function level is good;

Exclusion Criteria:

1. Her2-positive patients;
2. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
3. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
4. Previous or co-existing malignant neoplasms;
5. The presence of any active or known autoimmune disease;
6. People who have previously received an organ transplant;
7. Have clinical symptoms or diseases of the heart that are not well controlled;
8. Known allergic reactions to adebrelimab or other monoclonal antibodies or investigational drugs;

Primary outcomes:
measure: ORR based on RECIST v1.1 assessment.
timeFrame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years
Secondary outcomes:
measure: DCR based on RECIST v1.1 assessment
timeFrame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02678156: Assessment of the Performance of LYoplant® ONlay for Duraplasty
Official title: Assessment of the Performance of LYoplant® ONlay for Duraplasty. A Non-interventional, Multi-centre Post Market Clinical Follow-up (PMCF) Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniotomy
Duraplasty
Spinal Surgery
Keywords: Dura mater substitute
Graft
Lyoplant
Lyostypt
Lyoplant onlay
Xenograft
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2016-02-09
Enrollment: 61
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: adult patients

Brief summary: The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing an elective cranial or spinal surgery, probably with the need of a duraplasty using Lyoplant® Onlay
* Written informed consent
* Life expectancy \> 6 months
* Age \> 18 years

Exclusion Criteria:

* Active local or systemic infections
* Open cranial trauma
* Open spina bifida
* Known hypersensitivity to proteins of bovine origin
* Representation by a legal guardian or under involuntary commitment
* Pregnancy
* Participation in another clinical study
* Known primary immunodeficiency

Primary outcomes:
measure: Incidence of re-operation because of Cerebrospinal Fluid leakage
timeFrame: until discharge (approximately 1 week)
Secondary outcomes:
measure: Incidence of re-operation because of Cerebrospinal Fluid leakage
timeFrame: until follow-up (4 ± 2 months)
measure: Incidence of post operative complications
timeFrame: until discharge (approximately 1 week, 4±2 months)
measure: Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage
timeFrame: until discharge (approximately 1 week, 4±2 months)
measure: Intraoperative handling of the device
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
city: Homburg/Saar
country: Germany
facility: Klinik für Neurochirurgie
city: Idar-Oberstein
country: Germany
facility: Klinikum Idar-Oberstein
Study officials:
References:
Clinical trial NCT01505556: Proprioceptive Postural Control and Diaphragm Paresis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Proprioceptive Postural Control
Respiratory Disorders
Chronic Obstructive Pulmonary Disease
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2012-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients from the University Hospital Leuven - Respiratory Disvision

Brief summary: Proprioceptive weighting changes may explain differences in postural control performance. In addition, the respiratory movement has a disturbing effect on postural balance. Postural balance seems to be impaired in individuals with respiratory disorders. Increased risk of falling is reported in individuals with chronic obstructive pulmonary disease. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance.

The aim of the study is to clarify whether proprioceptive postural control is impaired in individuals with diaphragm paresis.


Eligibility criteria: Inclusion Criteria individuals with diaphragm paresis:

* Age: 18-70 years old
* Unilateral or bilateral diaphragm paresis following paresis of phrenic nerve
* Willingness to sign the informed consent

Inclusion Criteria healthy controls:

* Age: 18-70 years old
* Spirometry: FEV1/FVC ≥ 0.7 and FEV1 \> 80%
* Willingness to sign the informed consent

Exclusion Criteria:

* History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
* One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder
* Respiratory disorder other than diaphragm paresis
* Recent diagnosis of cancer
* Significant cardiovascular comorbidity

Primary outcomes:
measure: Proprioceptive postural control
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Simon Brumagne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Thierry Troosters, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Wim Janssens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Marc Decramer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.
Clinical trial NCT01475409: A Study on Changes in IFN-gamma Levels Following Anti-TNF Treatment in Patients Undergoing Serial QuantiFERON-TB Gold In-Tube
Official title: Dynamic Changes in IFN-gamma Plasma Levels Following Anti-TNF Treatment in Patients With Inflammatory Rheumatic Diseases Undergoing Serial QuantiFERON-TB Gold In-Tube Testing: a Prospective Study in a Low Tuberculosis Burden Country
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Rheumatic Diseases
Keywords: anti-TNF
tuberculosis
QuantiFERON-TB Gold In-Tube
tuberculin skin test
rheumatoid arthritis
spondyloarthritis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The screening for latent tuberculosis infection (LTBI) prior to the onset of anti-tumor necrosis factor therapy, as well as a watchful monitoring during the treatment, is strongly recommended. Tuberculin skin test (TST), universally used for this purpose, lacks sensitivity and specificity. The novel screening tools, including QuantiFERON-TB Gold In-Tube (QFT-GIT), have shown a higher specificity compared to TST, but their feasibility in the setting of immunosuppression remains unclear. Aims of this study were to investigate the performance of QFT-GIT and its agreement with TST in patients awaiting anti-tumor necrosis factor (TNF) therapy, and to evaluate the usefulness of serial QFT-GIT during the treatment with biologics to assess whether dynamic changes in interferon (IFN)-gamma levels may be helpful in identifying reactivation of LTBI or cases of newly acquired tuberculosis.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of inflammatory rheumatic diseases
* patients candidates to anti-TNF treatment

Exclusion Criteria:

Primary outcomes:
measure: Change from baseline in IFN-gamma plasma levels following serial QFT-GIT testing during the treatment with anti-TNF agents
timeFrame: From date of randomization (before anti-TNF treatment) until the date of repeated QFT-GIT testing (after 12 weeks and again after 24 weeks) for a total assessment of 7 months.
Secondary outcomes:
measure: Performance of QFT-GIT and its agreement with TST in patients under consideration for anti-TNF agents
timeFrame: From date of randomization (before anti-TNF treatment) until the date of acquisition of QFT-GIT and TST results, for a total of 1 month.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01927809: Genetic Mosaicism in Hirschsprung's Disease
Official title: Genetics of Hirschsprung's Disease - Can Genetic Mosaicism Due to Early Somatic Mutations, Explain Disease Development?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hirschsprung Disease
Keywords: Hereditary Diseases
Colon
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 90
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected in the two participating hospitals. The Erasmus MC - Sophia Children's hospital and the UMC St. Radboud.

Brief summary: Hirschsprung's disease is a complex genetic disorder. The etiology of this disease is not completely understood. It is characterized by the absence of ganglia (nerve cells) in de distal colon. This impairs bowel relaxation which can lead to bowel disfunction, toxic megacolon, ileus and enterocolitis. So far, several genes have been identified that play a role in Hirschsprung's disease. The precise mechanisms however, remain unclear. This study wants to identify new mutations and hopefully clarify more about the etiology of the disease.


Eligibility criteria: Inclusion Criteria:

* All children with Hirschsprung's disease that will receive a corrective pull through procedure

Exclusion Criteria:

* None

Primary outcomes:
measure: New somatic mutation
timeFrame: During surgery (coolection); after inclusion of approx. 25 patients (preliminairy analysis); final analysis after end of the study (approx. 3 years from first inclusion)
Secondary outcomes:
measure: Correlation disease type
timeFrame: At the end of the study (approximately 3 years after inclusion of first patient)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: UMC St Radboud
state: Gelderland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center - Sophia
state: Zuid-Holland
Study officials:
affiliation: Erasmus MC - Sophia
name: Rhiana Garritsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Katherine MacKenzie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00292409: A Study of Aripiprazole in Patients With Schizophrenia in General Psychiatric Practices
Official title: A Prospective Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia and Schizoaffective Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2006-02-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this clinical research study is to evaluate the overall effectiveness of 8 week of aripiprazole treatment.


Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenia or schizoaffective disorder being treated as outpatients,no response to past antipsychotic treatment and patients who symptoms are notoptimally controlled defined as CGI- S\<7

Exclusion Criteria:

* pregnant or breastfeeding,patients at risk for committing suicide,diagnosis of mood disorders, delirium, dementia and other cognitive disorders,patients treatment resistant to otherantipyschotic medications and treatment with a long acting psychotic in which the last dose was within 3 months of treatment phase

Primary outcomes:
measure: Clinical Global Impression-Improvement at endpoint
Secondary outcomes:
measure: Clinical Global Impression scale
measure: Investigator's Assessment Questionnaire
measure: Patient preference of medication at endpoint
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: