louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03148145: CalFitness Smartphone-Delivered Physical Activity Intervention With Messaging
Official title: Mobile Phone-Based Physical Activity Intervention on University Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Physical Activity
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal of this study is to test personalized mobile phone-based physical activity interventions among students at the University of California, Berkeley. Most physical fitness applications for smartphones and activity trackers use a constant goal for the number of steps each day. However, if the step goals are dynamically adjusted according to past behavior, then the corresponding goals may encourage individuals to increase their physical activity level. This study consists of a randomized controlled trial in which we are assessing the efficacy of four different algorithms for calculating personalized goals for the number of steps each day and for determining which motivational messages to send each day.


Eligibility criteria: Inclusion Criteria:

* intent to become physically active
* own an iPhone 5s (or newer model)
* willing to keep the iPhone in pockets during the day
* willing to install and use the intervention app every day for 4 months
* ability to speak and read English.

Exclusion Criteria:

* known medical conditions or physical problems that require special attention in an exercise program
* planning an international trip during the next 4 months, which could interfere with daily server uploads of mobile phone data
* pregnant/gave birth during the past 6 months
* severe hearing or speech problem
* history of an eating disorder
* current substance abuse
* current participation in lifestyle modification programs or research studies that may confound study results
* history of bariatric surgery or plans for bariatric surgery in the next 12 months.

Primary outcomes:
measure: Daily Steps Taken Per Day
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
Study officials:
References:
Clinical trial NCT06158945: The Role of Endothelin 1 as a Marker of Renal Impairment in Sickle Cell Disease
Official title: The Role of Endothelin 1 as a Marker of Renal Impairment in Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sickle Cell Disease
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients fulfilling all the following criteria will be included:

Patients with sickle cell disease in the age range of 1-18years

Brief summary: Sickle cell disease (SCD) refers to a group of hemoglobinopathies that include mutations in the gene encoding the beta subunit of hemoglobin. Within the umbrella of SCD, many subgroups exist, namely sickle cell anemia (SCA), hemoglobin SC disease (HbSC), and hemoglobin sickle-beta-thalassemia (beta-thalassemia positive or beta-thalassemia negative). Several other minor variants within the group of SCDs also, albeit not as common as the varieties mentioned above. It is essential to mention the sickle cell trait (HbAS), which carries a heterozygous mutation and seldom presents clinical signs or symptoms. Sickle cell anemia is the most common form of SCD


Eligibility criteria: Inclusion Criteria:

* The patients fulfilling all the following criteria will be included:
* Patients with sickle cell disease in the age range of 1-18years.

Exclusion Criteria:

* Patients diagnosed to have coexistent renal disease before the study

Primary outcomes:
measure: renal affection in sickle cell patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Williams TN, Thein SL. Sickle Cell Anemia and Its Phenotypes. Annu Rev Genomics Hum Genet. 2018 Aug 31;19:113-147. doi: 10.1146/annurev-genom-083117-021320. Epub 2018 Apr 11.
citation: Platt OS. Sickle cell anemia as an inflammatory disease. J Clin Invest. 2000 Aug;106(3):337-8. doi: 10.1172/JCI10726. No abstract available.
citation: Lonergan GJ, Cline DB, Abbondanzo SL. Sickle cell anemia. Radiographics. 2001 Jul-Aug;21(4):971-94. doi: 10.1148/radiographics.21.4.g01jl23971.
citation: Nath KA, Katusic ZS. Vasculature and kidney complications in sickle cell disease. J Am Soc Nephrol. 2012 May;23(5):781-4. doi: 10.1681/ASN.2011101019. Epub 2012 Mar 22.
Clinical trial NCT04622345: Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular Allergies
Official title: A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Allergic Conjunctivitis Using an Allergen Challenge Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-11-09
Enrollment: 41
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 determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of allergic conjunctivitis using an antigen challenge model


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age of either gender and any race
* Able to provide written informed consent and sign the HIPAA form
* Willing and able to follow all instructions and attend all study visits

Exclusion Criteria:

* Able and willing to avoid all disallowed medications during washout and study period

Primary outcomes:
measure: Ocular itching and redness as measured by self reported or investigator assessed numerical scales
timeFrame: 16 hours
Secondary outcomes:
measure: Ocular irritation measures such as chemosis, redness and eyelid swelling as assessed by the investigator on numerical scales
timeFrame: 16 hours
Other outcomes:
Locations:
city: Andover
country: United States
facility: Vanda Investigational Site
state: Massachusetts
Study officials:
References:
Clinical trial NCT04900545: Effect of Genetic Polymorphisms on Response to Beta Blocker Therapy in Egyptian Patients
Official title: Effect of Genetic Polymorphisms on Response to Beta Blocker Therapy in Egyptian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Hypertension
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Beta-Blocker naive Egyptian patient with acute coronary syndrome.

Brief summary: Beta-blockers represent a cornerstone for the treatment of coronary artery disease (CAD). Their protective effect is based on the negative inotropic and chronotropic features, which have been tested in a large number of randomized controlled trials, both in patients with myocardial infarction (MI) and in those with stable angina, demonstrating a reduction of adverse cardiovascular events, a relief of symptoms and a reduction of myocardial ischemia

However, considerable interpatient variability in response to β-blockers has been reported which indicates that a considerable proportion of β-blocker-treated patients do not achieve the warranted cardio protection with β- blockers. This highlights the importance of identifying biomarkers associated with variability in response to β-blockers to improve the current approach for β- blocker selection, which seems to be suboptimal.

This study aims to study the effect of polymorphism in adrenergic beta receptors on beta-blocker response in Egyptian patients.


Eligibility criteria: Inclusion Criteria:

1. Beta-blockers naïve patients
2. Patients been on beta-blocker therapy for at least 4 weeks.
3. Age (18-75) Years old.

Exclusion Criteria:

1. Non-Egyptians.
2. Kidney failure of any stage.
3. Liver failure of any stage.
4. Malignancy.
5. Pregnancy.
6. HR \< 55 beats/min (in the absence of b-blocker therapy).
7. Presence of a cardiac pacemaker.

Primary outcomes:
measure: Adrenergic receptors genes and blood pressure response to beta-blocker
timeFrame: Three months
measure: Adrenergic receptors genes and heart rate response to beta-blocker
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals.
state: Al Qahirah
Study officials:
affiliation: Ains Shams university
name: Nagwa A Sabry, PhD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Mohamed A Saleh, PhD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Amal A EL-Kholy, PhD
role: STUDY_DIRECTOR
affiliation: Ains Shams university
name: Mohamed S Fayed, Bsc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06287645: Color Fundus Photograph With Experts Labelling
Official title: Development of Digital Fundus Images Dataset of Local Population of Pakistan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinal Disease
Diabetic Retinopathy
Lead sponsor: Pakistan Council of Scientific and Industrial Research
Sponsor class: OTHER
Collaborators: name: Al-Ibrahim Eye Hospital
First posted: 2024-03-01
Enrollment: 50000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting the diabetic eye care center at our collaborated hospital will be registered for this study.

Brief summary: This trial aims to provide a digital retinal image dataset from Pakistan, graded by three specialists according to the severity of Diabetic Retinopathy. The dataset aims to improve research and patient care.

Detailed description: This clinical trial aims to address the scarcity of retinal image datasets in Pakistan by providing a comprehensive digital fundus photograph dataset, accompanied by expert grading. The dataset will encompass retinal images from Pakistani individuals, meticulously labeled by three Vitreo Retinal Specialists. These specialists will assess the presence and severity of common retinal disorders, including No Diabetic Retinopathy (No DR), Mild, Moderate, Severe, Proliferative Diabetic Retinopathy, Clinically Significant Macular Edema (CSME), and Advance diabetic Eye Diseases (ADED). Each image will also be evaluated for diagnostic clarity and the presence of any additional findings. Final grading decisions will be reached through unanimous consensus among the graders, ensuring the dataset's reliability and accuracy. This initiative holds promise for advancing ophthalmic research and improving patient care in Pakistan and beyond.

Eligibility criteria: Inclusion Criteria:

* Patients with Type I or Type II Diabetes.
* Patients of age of 20 years or above

Exclusion Criteria:

* The participant is unable or unwilling to comply with study procedures.
* Vulnerable participants (minors, legally detained individuals).
* Prisoners or subjects who are involuntarily incarcerated.

Primary outcomes:
measure: Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale
timeFrame: 1 Visit (1 day)
measure: Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale
timeFrame: 1 Visit (1 day)
measure: Finding inter-rater agreement among the graders
timeFrame: Two Years
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Al Ibrahim Eye Hospital
Study officials:
affiliation: Pakistan Council of Scientific and Industrial Research
name: Ghulam Mustafa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00484445: Transfer to Another Health Care Facility Following Critical Illness
Official title: Transfer to Another Health Care Facility Following Critical Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfer to a Health Care Facility After Critical Illness
Keywords: Chronic critical illness
Functional status
Outcomes
Post-ICU
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: The John A. Hartford Foundation
name: American College of Chest Physicians
name: Association of Subspecialty Professors
First posted: 2007-06-11
Enrollment: 548
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to an urban medical intensive care unit.

Brief summary: The purpose of this study is to identify acute and chronic medical conditions that are identifiable early in the course of critical illness that are associated with transfer to another health care facility (versus to home) upon hospital discharge.

Detailed description: Many patients who survive critical illness are unable to return home upon hospital discharge and require prolonged or permanent care in other health care facilities. It would be useful to clinicians, researchers, patients, and patients' families to be able to identify early in the course of critical illness those patients who are at increased risk for this outcome. Currently, few data exist regarding the risk factors for this outcome. This study examines a cohort of survivors of critical illness to identify factors associated with transfer to another health care facility upon hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Admission to the University of Chicago Medical Intensive Care Unit during the following periods: July 1997 to February 1998, November/December 2001, and March/April 2002.

Exclusion Criteria:

* Death during the index hospitalization.
* Residence in another health care facility 2 weeks prior to admission.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Hospitals
state: Illinois
Study officials:
affiliation: University of Chicago
name: Brian K Gehlbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02249845: Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children
Official title: Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dehydration
Keywords: dehydration
children
gastroenteritis
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 108
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Small children with acute diarrhoea admitted to the pediatric ward.

Brief summary: The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale, Gorelick scale) among small children.

Detailed description: The eligible patient admitted to the hospital with acute diarrhea, after given written consent for participation in the study by the child's parents, will be clinically assessed. Dehydration syndromes noted by physician will be recorded in special form (in attachment). Than, the child will be weighted on a standard scale.

The next body mass evaluation will take place, when patient's clinical condition will by classified as good by the attending physician and the child will be at least 24 hours after finishing intravenous or probe rehydration therapy.

Eligibility criteria: Inclusion Criteria:

* age: 1 - 36 months for CDS scale; 1 month - 5 years old for WHO scale and Gorelick scale
* hospitalisation caused by acute diarrhea (acute diarrhea -increase in the frequency of evacuations ≥ 3 in 24 hours; with or without fever or vomiting)
* duration of symptoms under 5 days
* parents' written consent for child's participation in the study

Exclusion Criteria:

* Dehydration caused by other mechanisms than acute diarrhea, for example dehydration caused by:

  * acidosis
  * kidney failure
  * heart failure
  * chronic liver disease
  * respiratory failure
  * condition after surgery

Primary outcomes:
measure: CDS scale evaluation
timeFrame: all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)
measure: WHO scale evaluation
timeFrame: all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)
measure: Gorelick scale evaluation
timeFrame: when all data will be collectedall necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Pediatrics, Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Anna Falszewska, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01274845: Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome
Official title: Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meconium Aspiration Syndrome
Keywords: Meconium aspiration syndrome
Heliox
Mechanical ventilation
Newborn
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 8
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study: to assess the effect of short-term mechanical ventilation with heliox in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance and respiratory function parameters.


Eligibility criteria: Inclusion Criteria:

* meconium aspiration syndrome diagnosed based on clinical and radiological findings,
* respiratory failure requiring mechanical ventilation

Exclusion Criteria:

* congenital malformations or congenital genetic syndromes,
* persistent pulmonary hypertension of the newborn (PPHN) requiring inhaled nitric oxide treatment

Primary outcomes:
measure: Changes in acid-base balance and oxygenation
timeFrame: Parameters recorded first at the baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.
Secondary outcomes:
measure: Changes in respiratory parameters
timeFrame: Parameters recorded first at baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Neonatology at Poznań University of Medical Sciences
Study officials:
affiliation: Department of Neonatology at Poznań University of Medical Sciences
name: Tomasz Szczapa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01764945: Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions
Official title: Relative Bioavailability of BI 201335 (Capsule) Compared to Three Different Oral Solutions of BI 201335 Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Four-way Crossover Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the current study is to investigate the relative bioavailability of two different doses of BI 201335, administered as soft gelatine capsule in comparison to the equivalent doses of three different oral solution per dose of BI 201335.


Eligibility criteria: Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditions

Primary outcomes:
measure: AUC0-∞
timeFrame: -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after administration of faldaprevir on Day 1.
measure: Cmax
timeFrame: -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.
measure: AUC0-tz
timeFrame: -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1220.46.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT04102345: Lavender vs Zolpidem Sleep Quality During Diagnostic PSG
Official title: Lavender vs Zolpidem: Sleep Quality During Diagnostic Polysomnography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Sleep
Keywords: aromatherapy
diagnostic sleep study
zolpidem
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized, pragmatic, clinical study.
Primary purpose: OTHER

Brief summary: In this pragmatic, clinical study the investigators propose that lavender aromatherapy is comparable to Zolpidem (Ambien) in improving the quality of diagnostic sleep studies.


Eligibility criteria: Inclusion Criteria:

* Age \>=18 years
* In-center diagnostic or split night sleep study (PSG)

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Sleep Efficiency
timeFrame: 1 day
Secondary outcomes:
measure: Number of Participants With A Successful Polysomnogram (PSG)
timeFrame: 1 day
measure: Wake After Sleep Onset (WASO)
timeFrame: 1 day
Other outcomes:
measure: Total Sleep Time (TST)
timeFrame: 1 day
measure: Sleep Onset Latency
timeFrame: 1 day
measure: Rapid Eye Movement (REM) Sleep Onset Latency
timeFrame: 1 day
measure: Stage 3/4 Sleep Percentage
timeFrame: 1 day
measure: Arousal Index
timeFrame: 1 day
Locations:
city: Maplewood
country: United States
facility: Regions Hospital Sleep Center
state: Minnesota
Study officials:
affiliation: Medical Director, Regions Hospital/HealthPartners Sleep Center
name: Charlene E McEvoy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: