louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06770777: Development And Evaluation of An Adaptive Web-Based Intervention for COPD
Official title: Development And Evaluation of An Adaptive Web-Based Intervention for Whole Health Support For Patients With Chronic Pulmonology Obstructive Disease (COPD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: asynchronous
whole health support
website based intervention
implementation
access to whole health care
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Narrative-based tiered asynchronous psychosocial and behavioral whole health support for people adjusting to living with COPD. The intervention is administered by experienced LCSWs under the PI's supervision.

Detailed description: This study will advance health access equity for people with Chronic Obstructive Pulmonary Disease (COPD) by providing an asynchronous, patient-led, web-based, adaptive, flexible, and tiered intervention that easily integrates into the daily lives of both providers and patients living with COPD. This intervention includes health navigation education, health and behavior coaching, and narrative, strengths-based mental and behavioral health support. COPD is a complex chronic illness with multiple domains to study whole person support. Not only because of the significant impact of a lack of whole person support for people living with COPD but also because COPD shares many of the same symptomology and impact on daily living as other significant chronic illnesses such as heart failure, some neurological disorders, and some types of cancer (5-7). The lessons learned from studying COPD whole person support can be applied to other similar symptomatic burdensome chronic illnesses that also suffer from fragmented care.

Eligibility criteria: Inclusion Criteria:

* Has access to the internet once per week
* Has been diagnosed with COPD and is being seen at the ECHCS VA Medical Center or the University of Colorado Pulmonology clinics

Exclusion Criteria:

* Not in a conflicting research study

Primary outcomes:
measure: Personal Health Questionnaire- 9 item (PHQ9)
timeFrame: 0 months, 3 months
Secondary outcomes:
measure: Generalized Anxiety Disorder-7 items (GAD7)
timeFrame: 0 months, 3 months
Other outcomes:
measure: St George Respiratory Questionnaire (SGRQ)
timeFrame: 0 months, 3 months
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
References:
Clinical trial NCT06144177: Induction in the Dark
Official title: Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anesthesia Induction
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 240
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will enroll children ages 2-6 who are undergoing an elective outpatient surgical procedure under general anesthesia. They will be randomized to one of the following groups and assessed for preoperative anxiety, mask acceptance, and behavioral changes in the following week.

1. darkened room and star projector with parental presence;
2. preoperative midazolam 0.5 mg/kg by mouth and parental presence; or
3. parental presence alone.


Eligibility criteria: Inclusion Criteria

* Age 2 to 6 years old
* American Society of Anesthesiologists physical status I-II
* Outpatient elective surgical procedures
* Undergoing general anesthesia
* Parent or guardian willing to be present during induction

Exclusion Criteria

* History of previous surgery
* Fear of the dark
* Contraindication to inhalational mask induction of general anesthesia such as allergy to inhalation medication, NPO violation, active nausea or vomiting, severe GERD, etc.
* Severe developmental delay
* Severe obvious, preoperative anxiety
* Patients currently using psychiatric medications
* Non-English speaking

Primary outcomes:
measure: Mask acceptance
timeFrame: during induction evaluated up until the start of the scheduled surgery
Secondary outcomes:
measure: Perioperative anxiety
timeFrame: Measured preoperatively, then measured again during the entry to operating room.
measure: Parental satisfaction of induction experience
timeFrame: evaluated after child's induction is complete up until the end of surgery
measure: Post-Operative Emergency Delirium
timeFrame: from PACU arrival until discharge
measure: Behavioral Changes
timeFrame: Day 1 Post-Op and Day 7 Post-Op, up to 30 days post-operatively
measure: Time to PACU discharge
timeFrame: time in recovery, up to 30 days post-op
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Natalie Barnett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05083377: Clozapine Use Pattern in the Province of Seville
Official title: Clozapine Use Pattern in the Province of Seville
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia and Related Disorders
Keywords: clozapine
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been prescribed (initially or regularly) clozapine during 2018, based on the casuistry provided by the Pharmacy service of the different hospitals.

Brief summary: CLOZAPINE USE PATTERN IN THE PROVINCE OF SEVILLE

Detailed description: Subjects with a diagnosis of schizophrenia (F20 of ICD-10) under treatment with clozapine in the province of Seville. The use of clozapine, variability between centers and treatment modification will be identified.

Eligibility criteria: Inclusion Criteria:

Patients who have been prescribed (initially or regularly) clozapine during 2018, based on the casuistry provided by the Pharmacy service of the different hospitals.

Exclusion Criteria:

* Parkinson's disease
* Dementia

Primary outcomes:
measure: Identify the pattern of clozapine use in the province of Seville
timeFrame: year 2018
Secondary outcomes:
measure: Analyze the variability between centers or professionals
timeFrame: year 2018
measure: Analyze the changes in the course of the disease since the prescription of clozapine
timeFrame: year 2018
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: benedicto.crespo.sspa@juntadeandalucia.es
name: Benedicto Crespo Facorro, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02539953: Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypotension
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: One in ten patients on rivaroxaban therapy have dizziness and reductions in blood pressure. The investigators intend to monitor the ambulatory blood pressure of such patients in order to assess whether this is a true haemodynamic effect.


Eligibility criteria: Inclusion Criteria:

* Aged 18-75 years
* Able to provide written, informed consent
* Taking rivaroxaban for any indication within the license of the drug, both once daily and twice daily dosing can be included
* Have measurable rivaroxaban levels on at least one occasion (this will be in line with standard of care, there will be no extra blood samples for the study)
* Not taking concomitant medication that can affect rivaroxaban metabolism (including amiodarone, dronedarone, -azole antifungals, protease inhibitors)
* On no antihypertensive or vasoactive medication
* Have a baseline BP recording taken in clinic

Exclusion Criteria:

* Unable to provide written, informed consent
* Presence of concomitant medication that may alter rivaroxaban levels and confound results (see above)
* Unwilling to undergo ambulatory blood pressure monitoring
* Contraindication to ambulatory blood pressure monitoring

Primary outcomes:
measure: Average blood pressure readings
timeFrame: 48 hours
Secondary outcomes:
measure: Correlation of blood pressure readings to rivaroxaban dosing
timeFrame: 48 hours
measure: Correlation of blood pressure readings to symptomatology
timeFrame: 48 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
Study officials:
affiliation: King's College Hospital NHS Trust
name: Roopen Arya, MBChB FRCP
role: STUDY_CHAIR
References:
Clinical trial NCT00150553: Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
Official title: A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: Validus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 102
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: The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.


Eligibility criteria: Inclusion Criteria:

* DSM-IV criteria for bipolar I disorder
* Screen YMRS score =\> 16
* Women of childbearing potential agree to take adequate precautions against contraception

Exclusion Criteria:

* Hospitalization required for treatment of psychiatric symptoms
* Patients who meet DSM-IV for ultra-rapid cycling
* History of serious suicide attempt requiring medical intervention

Primary outcomes:
measure: Score on Young Mania Rating Scale (YMRS) at 12 weeks
Secondary outcomes:
measure: Time to remission
measure: Clinical Global Impressions Scale - Bipolar Version
measure: HAM-D and MADRS scales for depression
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00779753: Determination of Lysine Requirement in the Parenterally Fed Neonate
Official title: Determination of Lysine Requirement in the Parenterally Fed Neonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenteral Lysine Requirements
Parenteral Feedings
Keywords: Parenteral Feeding
Neonate
Lysine
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to establish the parenteral lysine requirements for neonates.

Detailed description: It is important to identify the appropriate level of lysine requirements for parenterally fed neonates as this amino acid is the limiting amino acid in the diet of neonates. Feeding lysine at requirement improves the likelihood that other amino acids will be utilized appropriately for building proteins. In addition, lysine plays a major role in calcium absorption, development of muscle proteins and in the production of hormones, enzymes and antibodies. We believe that the lysine requirement will be 158 mg/kg/day which is significantly lower than the current 267 and 327 mg/kg/d that is found in the current Trophamine and Primene parenteral solutions.

Eligibility criteria: Inclusion Criteria:

* Clinically stable neonates on TPN
* minimum of 2.5 g/kg/d protein and 85 - 90 kcal/kg/d)
* Post conception age of ≥ 34 weeks gestation and appropriate for gestational age
* Weight of ≥ 1.5 kg
* NPO or ≤10% of total protein requirement consumed enterally

Exclusion Criteria:

* Infants on mechanical ventilators, supplemental oxygen or who are receiving medications that would alter protein or energy metabolism (ie. corticosteroid therapy, etc)

Primary outcomes:
measure: Oxydation of the Indicator Amino Acid L-[1-13C] phenylalanine will be measured through urine samples to determine urinary phenylalanine enrichment
timeFrame: 2 days
Secondary outcomes:
measure: Breath samples will be collected for the measurement of CO2 enrichment in expired air
timeFrame: 2 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto, Canada
name: Karen Chapman, RN, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chapman KP, Elango R, Ball RO, Pencharz PB. Splanchnic first pass disappearance of threonine and lysine do not differ in healthy men in the fed state. J Nutr. 2013 Mar;143(3):290-4. doi: 10.3945/jn.112.168328. Epub 2013 Jan 16.
citation: Chapman KP, Courtney-Martin G, Moore AM, Langer JC, Tomlinson C, Ball RO, Pencharz PB. Lysine requirement in parenterally fed postsurgical human neonates. Am J Clin Nutr. 2010 Apr;91(4):958-65. doi: 10.3945/ajcn.2009.28729. Epub 2010 Feb 17.
Clinical trial NCT05388253: Comparison of Static Stretching and Deep Kneading Massage Among Plantar Fasciitis Patients
Official title: Comparison of Static Stretching and Deep Kneading Massage Among Plantar Fasciitis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fasciitis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Comparison of Static Stretching and Deep Kneading Massage Among Plantar Fasciitis Patients

Detailed description: To find out the better type of intevention in Static Stretching and Deep Kneading Massage for the betterment of Plantar Fasciitis Patients

Eligibility criteria: Inclusion Criteria:

* A person with phytoplitis by a doctor, physiotherapist or orthopedic surgeon.
* Determine the patient's age between 40 and 60 years.
* The patient's fracture, fracture, most cancers and various metabolism disorders are not used. Male and female victims can be involved.

Exclusion Criteria:

* Inflammatory arthritis patients.
* Nerve distortions
* Another disease caused in the case of March.
* Patients with various basic muscle problems and the effects of red science
* Does not use the patient's latest records and footprint.

Primary outcomes:
measure: Static Stretching Among Plantar Fasciitis Patients
timeFrame: 6 Months
Secondary outcomes:
measure: Deep Kneading Massage Among Plantar Fasciitis Patients
timeFrame: 6 Months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hospitals
Study officials:
References:
Clinical trial NCT00674453: The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation
Official title: The Effect Of Lasofoxifene On Local Mediators Of Bone Resorption In The Prevention Of Postmenopausal Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Loss
Keywords: Osteoporosis
lasofoxifene
bone density
bone markers
Lead sponsor: Ligand Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 51
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the study is to demonstrate the effects that lasofoxifene has on serum markers of bone metabolism.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women over 50 years who have low bone mineral density.

Exclusion Criteria:

* Women who are under 50 years of age, are premenopausal, or who currently have osteoporosis are excluded.

Primary outcomes:
measure: Change in bone mineral density of the lumbar spine.
timeFrame: 2 years
Secondary outcomes:
measure: The secondary outcomes are the levels of cells and proteins in the blood that provide information about the health of bone, along with change in bone mineral density of the hip and forearm.
timeFrame: 2 years
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03040453: Immunological Response After Ablative Therapy in the Liver
Official title: Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Immune Response
Keywords: Irreversible electroporation
Microwave ablation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not eligible for liver transplant or liver resection. At our Hospital two different methods are used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible electroporation, where the tumor cells are exposed to an electrical field and nano-pores are formed in the cell membranes and the cells go into apoptosis (programed cell death).

Previous studies have shown effects on the immune system after ablative therapies.

The purpose of this study is to compare the immunological response after the wo different methods of killing the tumor cells.


Eligibility criteria: Inclusion Criteria:

* Hepatocellular carcinoma, maximum 3 lesions, maximum 30 mm in any cross section diameter
* Physically fit to undergo general anaesthesia
* Fully understand swedish instructions regarding the study

Exclusion Criteria:

* Atrial fibrillation (for irreversible electroporation)
* Pacemaker (for irreversible electroporation)
* \>3 lesions
* \> 30 mm in any cross section diameter

Primary outcomes:
measure: Immunological response
timeFrame: Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90
Secondary outcomes:
measure: Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months.
timeFrame: Follow-up every three months for one year with CT scan.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Surgery and Urology, Danderyd Hospital
Study officials:
affiliation: Karolinska Instituet
name: Jacob Freedman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03564353: Investigating Memory in Healthy Subjects Using Transcranial Direct Current Stimulation
Official title: Investigating Memory in Healthy Subjects Using Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: transcranial Direct Current Stimulation (tDCS)
memory
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of four groups: (1) tDCS targeting location 1 paired with memory task (2) tDCS targeting location 2 with memory task (3) tDCS targeting location 3 paired with memory task (4) tDCS targeting location 4 paired with memory task
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate whether we can improve associative memory performance in healthy subjects, by applying transcranial Direct Current Stimulation (tDCS) during a verbal paired-associate learning task

Detailed description: Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer's disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.

Transcranial Direct Current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has demonstrated to accelerate learning and improve memory in some studies. To investigate whether it is possible to improve associative memory using tDCS, the performance in a Verbal Paired-Associate memory task of 4 groups targeting different areas will be compared.

Eligibility criteria: Inclusion Criteria:

* Age: 18-35 years
* Native English Speaker

Exclusion Criteria:

* History of severe head injuries, epileptic insults, or heart disease.
* Severe psychiatric disorders and severe untreated medical problems.
* acquainted with the foreign language used in the learning task
* Contraindications for tDCS (pregnant women, implanted devices)

Primary outcomes:
measure: Associative Memory Assessed by a Verbal Paired-Associate Test
timeFrame: Baseline and 1 week after the tDCS
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: The University of Texas of Dallas
state: Texas
Study officials:
References: