louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04724213: Development of an Assessment Tool for Health-related Quality of Life in Children and Adolescents With Pompe Disease
Official title: Development and Validation of a Standardized Assessment Instrument for Health-related Quality of Life (HrQoL) in Children and Adolescents With Pompe Disease (PD): a Joint Effort of Patients, Caregivers and Metabolic Experts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pompe Disease
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2021-01-26
Enrollment: 101
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Health related quality of life (HrQoL), is "the patient's subjective perception of the impact of his disease and its treatment on his daily life, physical, psychological and social functioning and well-being" and thus constitutes a patient reported outcome (PRO) of utmost importance. Generic HrQoL instruments can by definition not capture disease-specific parameters nor are they sensitive enough to detect their changes. In this study, a disease-specific HrQoL questionnaire for children and adolescents will be developed. Patients and parents will be involved in focus groups and interviews to identify relevant contents. The instrument will be tested for validity and reliability.


Eligibility criteria: Inclusion Criteria:

* Patients with PD from age 8 years

  * Parent of patient(s) \< 18 years with PD
  * Able to give informed consent as documented by signature
  * Sufficient command of the German language

Exclusion Criteria:

* - Inability to follow the procedures of the study, e.g. due to language problems or severely reduced health status

Primary outcomes:
measure: Reliability/ validity of questionnaire
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Childrens Hospital Zürich
Study officials:
affiliation: University Childrens Hospital Zurich
name: Martina Huemer, Prof dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04455113: Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU
Official title: Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Hypophosphatemia on Septic Patients
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included all patients admitted to ICU for sepsis, severe sepsis and septic shock.

All patients included except mentioned above exclusion criteria.

Brief summary: Patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of developing morbidities other than that underlying sepsis and more vulnerable to higher mortality rate. Thus, the current study hypothesized that diagnosis and management of hypophosphatemia may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to ICU

Detailed description: The current study was started since June 2018 till Jan 2020 after approval of the study protocol by the Local Ethical Committee. The study intended to include all patients admitted to ICU with or developed severe sepsis or septic shock within 24-hr after admission to ICU.

All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data. Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores. Exclusion criteria included maintenance on immunodepressent therapy for any indication, severe hemorrhagic shock, pregnancy and refusal of nearest relative to sign the written concept for study participation. Children and adulthoods younger than 18 years and patients who were expected to die were also excluded from the study.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data.
* Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores.

Exclusion Criteria:

* Maintenance on immunodepressent therapy.
* Severe hemorrhagic shock.
* Pregnancy
* Refusal of nearest relative to sign the written concept for study participation.

Primary outcomes:
measure: The 28-day ICU mortality rate (28-MR)
timeFrame: 28 days
Secondary outcomes:
measure: The incidence of additional morbidities.
timeFrame: 30 days
measure: The correlation between 28-MR and incidence of additional morbidities and severity of HP.
timeFrame: 28 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT02217813: A Bioequivalence Study Comparing Two Different Tafamidis Formulations
Official title: A Phase 1, Open-label, Randomized, Crossover, Single Dose Study To Determine The Bioequivalence Of Pf-06291826 (Tafamidis) 20 Mg Capsule Manufactured By Catalent Versus Capsule Manufactured By Pii In Healthy Subjects Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis blood concentrations will be measured periodically for one week. After about 20 days, subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis concentrations from the two different formulations will be compared to determine if they are approximately the same.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 Kg and total body weight more than 50 Kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.

Primary outcomes:
measure: Area under the Concentration-Time Curve (AUC)
timeFrame: 168 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 168 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: 168 hours
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 168 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 168 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 168 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06779513: Validation and Assessment of Novel Morphology-Voltage-P-wave Score for Diagnosing Left Ventricular Diastolic Dysfunction in Patients With Hypertension
Official title: Validation and Assessment of Novel Morphology-Voltage-P-wave Score for Diagnosing Left Ventricular Diastolic Dysfunction in Patients With Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with essential hypertension who came to out hospital

Brief summary: This study aimed to assess and validate the diagnostic utility of a novel Morphology-Voltage-P-wave Score (MVP Score) in identifying left ventricular diastolic dysfunction among patients with hypertension.

Researchers will collect information of patient with hypertension and underwent transthoracal echocardiography assessment. The data consist of demographic data, clinical presentation, laboratory, and echocardiography result were collected by two investigators. Then, the data was analyzed by using IBM SPSS Statistics v26.


Eligibility criteria: Inclusion Criteria:

* Essential hypertension

Exclusion Criteria:

* Secondary or resistant hypertension
* LVEF\<55%
* Congenital heart disease
* Infiltrative cardiomyopathy
* Coronary artery disease
* Chronic kidney disease
* Valvular heart disease
* Bundle branch block
* Arrhythmia

Primary outcomes:
measure: Diastolic Dysfunction
timeFrame: Up to 1 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Dr. Kariadi Central General Hospital
state: Central Of Java
Study officials:
References:
Clinical trial NCT04355013: Temperature Monitoring in Cardiac Surgery: Agreement Between Different Clinical Methods
Official title: Temperature Monitoring in Cardiac Surgery: Clinical Study of Agreement Between Different Measurement Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temperature Change, Body
Keywords: Core temperature
Cardiac surgery
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery under cardiovascular bypass

Brief summary: Observational study to compare core temperatures obtained by 6 methods in patients undergoing cardiac surgery under cardiopulmonary bypass.

Detailed description: This study compares the core temperatures obtained by means of different probes placed in nasopharinx, pulmonary artery, arterial outlet, venous inlet, bladder and forehead in patients undergoing cardiac surgery under cardiopulmonary bypass.

Eligibility criteria: Inclusion Criteria:

* Only patients requiring a pulmonary artery catheter were included.

Exclusion Criteria:

* Sepsis or previous fever.
* Previous bladder catheter without termistor
* Deep hypothermic circulatory arrest.

Primary outcomes:
measure: Agreement Between Different Core Temperature Methods
timeFrame: 24 temperature measures per patient recorded at 5-min intervals for each method and averaged using the Bland-Altman method for repeated measures
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: IBSAL
Study officials:
References:
citation: Sastre JA, Lopez T, Moreno-Rodriguez MA, Reta-Ajo L, Rubia-Martin MC, Diez-Castro R. Reliability of different body temperature measurement sites during normothermic cardiac surgery. Perfusion. 2023 Apr;38(3):580-590. doi: 10.1177/02676591211069918. Epub 2022 Feb 8.
Clinical trial NCT01701713: TDCS in Acute Stroke
Official title: Safety Study of Transcranial Direct Current Stimulation in Aphasia Therapy in Acute and Post-acute Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: TDCS
STROKE
APHASIA
NAMING
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Brandenburg Klinik, Bernau, Germany
name: University of Potsdam
First posted: 2012-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the safety of transcranial direct current stimulation in aphasia therapy in acute and post-acute stroke.

Detailed description: TDCS has been shown to have a positive effect on clinical outcome in both motor rehabilitation and aphasia treatment in chronic aphasic patients. In healthy subjects the method sped up reaction times in naming and language learning tasks. In TDCS a weak current is applied to the subjects head increasing excitatory activity which might lead to improved brain function.

Eligibility criteria: Inclusion Criteria:

* first media stroke
* language impairment
* informed consent
* right handedness
* NIHSS \< 20

Exclusion Criteria:

* previous Epilepsy oder epileptogenic events
* epilepsy typical elements in EEG
* hypersensitive skin (head)
* metal implants (head)
* pace maker or other electronic implants
* previous head/brain surgery
* medication reducing seizure threshold
* previous psychiatric events

Primary outcomes:
measure: skin irritation
timeFrame: 2 months
Secondary outcomes:
measure: Improved language
timeFrame: 2 months
Other outcomes:
Locations:
city: Bernau
country: Germany
facility: Brandenburg Klinik Bernau
state: Brandenburg
city: Berlin
country: Germany
facility: Charité, Campus Benjamin Franklin, Dep. of Neurology
Study officials:
affiliation: Center for Stroke Research Berlin (CSB), Charité
name: Gerhard J Jungehuelsing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brandenburgklinik Bernau
name: Michael Joebges, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06728436: Testing the Effects of a Text Message Caregiver Support Intervention for Latinos
Official title: Testing the Effects of a Text Message Caregiver Support Intervention for Latinos
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of Puerto Rico
name: Icahn School of Medicine at Mount Sinai
name: University of Miami
First posted: 2024-12-11
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized clinical trial it to test the efficacy of CuidaTEXT, the first Alzheimer's disease and Related Dementias (ADRD) caregiver support intervention to capitalize on text messaging, among Latinos.

Researchers will compare those who receive the CuidaTEXT intervention to those who do not receive the intervention to see if CuidaTEXT effects Latino caregiver stressors and their negative consequences .

Participants will receive a variety of text messages, from automatic to keyword-drive, regarding ADRD education, social support, self-care, ADRD care management, and behavioral symptoms. Participants will also complete measures regarding depressive symptoms, coping, behavioral symptoms, and preparedness for caregiving.


Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Spanish and English-speaking people who identify as Latino
* Reports providing hands-on care for a relative who has been given a clinical or research ADRD diagnosis and has an Eight-item Informant Interview to Differentiate Aging and Dementia (AD-8) screening score ≥2, indicating cognitive impairment
* Has a score of 7 or higher on the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10)
* Self-reports being able to read and write
* Owns a cell phone with a flat fee, and uses it at least weekly for texting.

Exclusion Criteria:

* Participation in another wellbeing-related clinical trial
* Cohabitation with another participant in the CuidaTEXT R01 Study
* Participants who provide care for a person with ADRD already cared for by another participant in the CuidaTEXT R01 study
* Participant plans to move to another country within seven months

Primary outcomes:
measure: Change in caregiver depressive symptoms
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in caregiver behavioral distress symptoms
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Fairway
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jaime Perales Puchalt, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05263336: Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum
Official title: The Efficacy of Intraoperative ICG Angiography in Assuring Optimal Blood Supply to the Anastomosis in Rectal Cancer Patients Undergoing Laparoscopic Anterior Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: rectal cancer
laparoscopic anterior resection
intraoperative angiography
ICG
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study enrols patients with operative rectal cancer qualified for laparoscopic anterior resection. Patients are given first dose of indocyanine green iv intraoperatively (ICG) before choosing the appropriate site of the anastomosis, and the second dose after performing the anastomosis to confirm adequate blood supply to the anastomotis. The main outcome assessed is the frequency o anastomotic leak in comparison to the group of patients that do not undergo intraoperative ICG angiography.


Eligibility criteria: Inclusion Criteria:

* operative rectal cancer

Exclusion Criteria:

* known allergy toward indocyanic green

Primary outcomes:
measure: Anastomotic leak
timeFrame: Up to two weeks post surgery
Secondary outcomes:
measure: Postsurgical Ileus
timeFrame: Up to 10 days post surgery
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: St John Grande Hospital
state: Lesser Poland
Study officials:
References:
Clinical trial NCT03939936: The Effect of Periodontal Treatment on Psoriasis
Official title: Effects of Non-surgical Periodontal Therapy on Inflammatory Markers of Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Psoriasis
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is a relationship between psoriasis and periodontal disease. This relationship may be double-sided.

Detailed description: The aim of this randomized controlled clinical study was to determine the effect of non-surgical mechanical periodontal treatment on psoriasis. The study population consisted of 92 periodontitis patients with psoriasis who had untreated periodontal disease. Two randomized groups were formed from these patients. Immediate periodontal treatment (test group, n = 46) and delayed periodontal treatment (control group, n = 46). Clinical periodontal measures, saliva interleukin 2, interleukin 6 and secretory immunoglobulin A levels and PASI scores were performed at baseline and 8th week in control and test group.

Eligibility criteria: Inclusion Criteria:

* the presence at least 20 remaining teeth,
* the presence of Stage I or Stage II Periodontitis,
* the presence of diagnosed psoriasis.

Exclusion Criteria:

* patients who had the immune-inflammatory disease and require antibiotic prophylaxis,
* patients who received periodontal treatment prior to 6 months,
* women who were breastfeeding or pregnant,
* patients using medicines such as antibiotics, anti-inflammatory drugs, immune-suppressants.

Primary outcomes:
measure: Proinflammatory cytokines
timeFrame: Baseline and after 8 weeks
Secondary outcomes:
measure: Gingival index
timeFrame: Baseline and after 8 weeks
measure: PASI index
timeFrame: Baseline and after 8 weeks
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Gaziosmanpasa Universty
name: Atiye Ogrum
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04769336: Effectiveness of Point of Care Complete Blood Cell Count Analyzer in Reducing Time to Results
Official title: Effectiveness of Point of Care Complete Blood Cell Count Analyzer in Reducing Time to Results
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laboratory Problem
Lead sponsor: Northwestern Medicine
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients coming for surgery

Brief summary: The current process for getting complete blood cell counts (CBC) results in the operating room during surgery relies on sending blood samples from the operating room to the hospital's central lab. This workflow is complex and often results in handing off the blood sample to 4 or more different staff members before arriving in the lab for analysis. This often causes delayed CBC results, which may lead to inappropriate or delayed clinical decision making. By providing prompt access to CBC results with the use of a point of care CBC analyzer, the clinical workflow efficiency can be significantly improved. This should resulting in better clinical decision making, reductions in costs, increase in patient satisfaction and facilitation of hospital processes.


Eligibility criteria: Inclusion Criteria:

* All English speaking patients, 18 years or older, having surgery in the Lake Forest Hospital operating rooms, with a pre-existing indication for CBC analysis.

Exclusion Criteria:

* All patients not meeting inclusion criteria or protected patient populations, specifically, pregnant women, prisoners, cognitively impaired patients, patients unable to consent, students, employees, and children)

Primary outcomes:
measure: Time to result
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Northwestern Lake Forest Hospital
state: Illinois
Study officials:
References: