louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03644953: Hydroxyurea and Transfusion
Official title: Hydroxyurea and Transfusion: Pilot Study of Combination Therapy for Patients With Sickle Cell Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sickle Cell Disease
Keywords: Hydroxyurea
Transfusion
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 14
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single arm, open label study of combination hydroxyurea and simple chronic transfusion.
Primary purpose: TREATMENT

Brief summary: This study will prospectively investigate the feasibility, safety, and transfusion requirements of adding hydroxyurea to simple chronic transfusions for patients with sickle cell anemia already on chronic transfusions.

Detailed description: This is a single-arm, prospective study of hydroxyurea added to simple chronic transfusions, combination treatment termed hydroxyurea and transfusion (HAT). The primary objective of the study is to determine the feasibility of HAT for patients with sickle cell anemia (SCA) currently being treated only with simple transfusions for stroke prevention. Secondary objectives include: to evaluate the safety of HAT and to determine if HAT decreases transfusion requirements in this patient population. Exploratory objectives include: to evaluate with HAT changes in pre-transfusion laboratories and biomarkers of cerebrovascular disease progression, and to describe changes on brain imaging.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of SCA (Hb SS or Sβ0 thalassemia).
2. On simple chronic transfusion therapy for stroke prevention (primary or secondary prevention) for ≥1 year with no plans to stop simple chronic transfusion in the next year.

Exclusion Criteria:

1. Poor adherence to simple transfusion regimen as defined by having an HbS \>45% at any time in the last year AND a transfusion interval \>5 weeks.
2. Treatment with hydroxyurea in the 12 months prior to study enrollment.
3. Abnormal initial laboratory values (temporary exclusions):

   1. Absolute neutrophil count \<1.5 x 10\^9/L
   2. Platelet count \<100 x 10\^9/L
   3. Serum creatinine more than twice upper limit for age
4. Pregnancy or unwillingness to use a medically acceptable form of contraception if sexually active.

Primary outcomes:
measure: Recruitment ratio
timeFrame: 1 year
measure: Retention ratio
timeFrame: 1 year
measure: Hydroxyurea adherence ratio
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of subjects who develop an hemoglobin (Hb) S >45% AND an Hb >11.0 g/dL
timeFrame: 1 year
measure: Volume of red blood cells transfused per patient weight
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
References:
Clinical trial NCT06047353: Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
Official title: Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-09-21
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research is to compare the impact of motivational enhancement therapy (MET), delivered by culturally congruent community health care workers (CHWs) versus usual care patients with previously untreated moderate-to-severe obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy.


Eligibility criteria: Inclusion Criteria

* ≥ 18 years of age
* Moderate-to-severe OSA
* Available to attend study visits and sessions
* Reliable access to a phone

Exclusion Criteria

* Prior or current use of PAP therapy or other treatment (e.g., oral appliance) for OSA
* History of upper airway surgery for OSA
* Moderate to severe insomnia
* Commercial drivers
* Use of non-standard PAP including adaptive servo-ventilation or bi-level positive airway pressure
* Report of motor vehicle accident or near-miss due to sleepiness within the 2 previous years
* Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
* Other sleep disorders (e.g., circadian rhythm disorder)
* Use of supplemental oxygen during wakefulness or sleep
* Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep apnea test
* Resting awake oxygen saturation (SpO2) \< 90%
* Participation in another clinical trial

Primary outcomes:
measure: Number of hours patient adhered to PAP therapy
timeFrame: 3 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 3 months
measure: Mean Glucose Level
timeFrame: 3 months
measure: Epworth Sleepiness Scale Score
timeFrame: 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Naresh Punjabi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01865253: Renal Denervation for Complicated Hypertension
Official title: Renal Denervation for Complicated Hypertension (RDNP-2012-03)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension
Keywords: renal denervation
blood pressure
cardiovascular risk
target organ damage
sympathetic activity
chronic kidney disease
non-compliance
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to:

* intolerance to antihypertensive medication
* inability to take antihypertensive medication due to planned pregnancy
* renal artery stenosis
* chronic kidney disease
* non-compliance to antihypertensive medication

A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study.

The duration of this study is 36 months.


Eligibility criteria: Inclusion Criteria:

* BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
* Intolerance to ≥2 antihypertensive drug classes
* Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy
* Renal artery stenosis
* Chronic Kidney Disease

Exclusion Criteria:

* renal artery anatomy ineligible for treatment
* individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
* female participants of childbearing potential must have negative pregnancy test prior to treatment

Primary outcomes:
measure: Change in average office blood pressure
timeFrame: baseline to 6 months post procedure
Secondary outcomes:
measure: Blood pressure control
timeFrame: baseline to 6 months post procedure
measure: Number of drugs required to reach target blood pressure
timeFrame: baseline to 6 months post procedure
measure: Time to achieve blood pressure target
timeFrame: baseline to 6 months post procedure
measure: Change in sympathetic nerve activity
timeFrame: baseline to 6 months post procedure
measure: Change in left ventricular structure and function
timeFrame: baseline to 6 months post procedure
measure: Change in Quality of life
timeFrame: baseline to 6 months post procedure
measure: Change in serum and urine Biochemistry
timeFrame: baseline to 6 months post procedure
measure: Change in markers of arterial stiffness
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker IDI Heart & Diabetes Institute
state: Victoria
Study officials:
affiliation: Baker IDI Heart & Diabetes Institute
name: Markus P Schlaich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01418053: The Effect of Hot Cataplasm With Caraway Oil in the Treatment of Irritable Bowel Syndrome
Official title: Randomised Controlled Study on the Effect of a Kneipp Hot Cataplasm With Caraway Oil in the Treatment of Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a daily use of a Kneipp hot cataplasm with caraway oil is effective in the treatment of abdominal pain and complaints caused by Irritable bowel syndrome.

Detailed description: see above.

Eligibility criteria: Inclusion Criteria:

* Irritable Bowel Syndrome according to Rom-III
* Subtype Diarrhea or Alternating
* discomfort or pain \> 1 times a week
* discomfort or pain \> 4 on a Visual Analog Scale

Exclusion Criteria:

* Inflammatory bowel diseases (test results necessary)
* Lactose, Fructose Malabsorption (test results necessary)
* Celiac Disease
* Pregnancy or Breastfeeding
* Colectomy or Hemicolectomy \>50cm
* Severe metabolic disorders, hormonal disorders, cardiac or respiratory failure, liver or renal diseases
* severe depression, psychotic or psychiatric disorders, substance abuse
* cancer within the last 5 years
* allergy to caraway
* acute inflammatory diseases

Primary outcomes:
measure: Irritable Bowel Syndrome - Symptom Severity Score
timeFrame: at T2 (Day 21)
Secondary outcomes:
measure: Frequency of abdominal discomfort/Pain
timeFrame: last week of treatment (days 14-21)
measure: Intensity of abdominal discomfort/Pain
timeFrame: last week of treatment (days 14-21)
measure: Quality of life
timeFrame: T2 (Day 21)
measure: Quality of life - ibs specific
timeFrame: T2 (day 21)
measure: Depression and Anxiety
timeFrame: T2 (day 21)
measure: Global improvement
timeFrame: At day 7, 14 and 21
measure: h-BD2
timeFrame: T2 (day 21)
measure: Adequate Relief Score
timeFrame: at day 7, 14, 21
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Klinik für Naturheilkunde und Integrative Medizin
Study officials:
affiliation: University Duisburg-Essen, Chair of Integrative Gastroenterology
name: Jost Langhorst, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauche R, Janzen A, Ludtke R, Cramer H, Dobos G, Langhorst J. Efficacy of Caraway Oil Poultices in Treating Irritable Bowel Syndrome--A Randomized Controlled Cross-Over Trial. Digestion. 2015;92(1):22-31. doi: 10.1159/000398790. Epub 2015 Jun 5.
Clinical trial NCT04579653: Pupillometry and Locus Coeruleus Activation (PuLCA)
Official title: Effects of Various Non-invasion Stimulation Parameters on Pupil Dilation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Visual Impairment
Ocular Illness
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study has a within-subjects design with a randomization of the order of tVNS administered parameters
Primary purpose: BASIC_SCIENCE

Brief summary: This project will apply non-invasive, trans-cutaneous vagal nerve stimulation using various stimulation parameters to young, healthy adults to find the optimal set of parameters to elicit pupil response.


Eligibility criteria: Inclusion Criteria:

* Fluent English speaker with reading and writing proficiency.

Exclusion Criteria:

* Participants with significant visual impairment or ocular illness may be excluded at the discretion of the principal investigator.
* Major medical illnesses including severe neurological illness (e.g. stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia)
* Any history of brain surgery, tumor, intracranial metal implantation, pacemakers, or other implanted devices.
* Current (i.e. within 48 hours of the session) prescription medication or over-the-counter medication use.
* Illicit alcohol or drug use. Caffeine (e.g, coffee, energy drinks) consumption prior to the visit.

Primary outcomes:
measure: Ocular response after transcutaneous nerve stimulation
timeFrame: Visit 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Eric Porges, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06542653: Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion
Official title: Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Atheroscleroses
Keywords: Chronic total occlusion
Percutaneous coronary intervention
Major adverse cardiovascular events
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery. The enrolled patients were divided into 2 groups, i.e., CTO-PCI group (n=187) and CTO-OMT group (n=46). The strategy to perform PCI on CTO patients was dependent on some factors, including co-morbidity, technical challenges, operators' preference

Brief summary: Coronary chronic total occlusions (CTOs) are considered to increase the risk of adverse clinical outcomes. The purpose of this study was to evaluate whether long-term clinical outcomes could be improved by successful percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) in CTO patients.

Detailed description: patients with CTO lesions undergoing PCI at the First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2017 were enrolled. After someone were excluded due to CABG surgery, patients who met the enrollment criteria were divided into successful CTO-PCI group and CTO-OMT group based on the treatment received. The study primary endpoint was major adverse cardiac cerebrovascular events (MACCE), including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke. The secondary endpoint was all-cause death.

Eligibility criteria: Inclusion Criteria:

* patients with at least one coronary CTO lesion at our hospital in between January 2011 and December 2017

Exclusion Criteria:

* (1) patients with ST-segment elevation myocardial infarction (STEMI)
* (2)a history of coronary artery bypass grafting (CABG)
* (3) cardiogenic shock
* (4) malignant tumor. Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery.

Primary outcomes:
measure: major adverse cardiac cerebrovascular events (MACCE)
timeFrame: January 2011 to December 2023
Secondary outcomes:
measure: all-cause death
timeFrame: January 2011 to December 2023
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Leilei Chen
role: STUDY_DIRECTOR
References:
Clinical trial NCT05535153: Reproducibility of the Functional Movement Screen Test
Official title: Reproducibility of the Functional Movement Screen Test in the Normandy Amateur Rugby Player
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locomotor Pain Disorder
Keywords: FMS, rugby
Lead sponsor: Pole Sante Grace de Dieu
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects recruited are rugby players aged 18 to 55, playing or having played in the "Amateur" and "Senior" categories.

Brief summary: The main objective of the study is to determine the inter-evaluator and intra-evaluator reproducibility of the FMS test as an evaluation tool in amateur rugby players.

The secondary objective of the study is to evaluate the abilities of the FMS test as a predictive tool for detecting possible injuries during a sports season in amateur rugby players.

Detailed description: Rugby is a very popular sport in France, since it has more than 300,000 dismissed. The 2023 World Cup will take place in France, and in view of the enthusiasm that is created around the "XV de France" team, there will be a great number of new players. Yet there are many injuries in this sport, despite the adaptations of the French Rugby Federation. The injuries of these amateur players will handicap their performance within their club (an injured player will be injured more easily in the future) and have a impact on their personal and professional life. With this in mind, it would be desirable to have a predictive tool for possible wounds. For this, Agullo et al. had in the previous study "Reproducibility of the Functional Movement Screen (FMS) test in the amateur Rugby player" (ID-RCB: 2018-A03490-55) selected this tool already evaluated in the context of prediction injuries in other sports (hockey or American football). The FMS offers an overall assessment of the subject, based on seven so-called movements fundamentals, combining mobility and stability, making it possible to assess the deficiencies of the individual; a prevention plan will then be adapted to the subject.

Eligibility criteria: Inclusion Criteria:

* Rugby players in the "Amateur" and "Senior" categories
* Must be able to play a match within a week of the FMS test evaluation.

Exclusion Criteria:

* players evolving or having evolved beyond the "Federal 3" division for men or "Federal 1" for women
* Pregnant and breastfeeding women
* People in an emergency situation
* People unable to give their consent (including people under guardianship)
* Patients already involved in another study.

Primary outcomes:
measure: Functional Movement Screen
timeFrame: 1 year
Secondary outcomes:
measure: Functional Movement Screen
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Caen
country: France
facility: PSLA GDD
Study officials:
References:
Clinical trial NCT03876353: University of New Mexico Dental Hygiene
Official title: Efficacy of Flossing in the Removal of Oral Plaque Biofilm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Plaque Biofilm
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate the efficacy of flossing in the removal of oral plaque biofilm.

Detailed description: Flossing is universally recognized in the dental profession as a primary component of oral hygiene. Data supports the correlation between flossing and disease prevention by ways of reducing gingival bleeding, gingivitis, and dental caries.(1, 2) However, a recent AP publication (3) questioning the validity of flossing as an efficacious preventative method has warranted that oral healthcare professionals address certain underlying assumptions about the practice. Specifically, there is a clear gap in the number of clinical effectiveness trials that measure the ability of flossing for the sole purpose of oral plaque biofilm removal. Such studies are urgently needed. At this moment we can only assume flossing's correlation with disease prevention also links flossing with effectively removing oral plaque biofilm. Due to the current research gaps, additional studies must be performed to address the needs highlighted by the absence of substantive research in this field.

Our long term goal is to evaluate if flossing is an effective oral health aid in the removal of oral plaque biofilm. The overall objective of this application is to provide a consistent measurement to confirm whether flossing is an effective oral care technique in removing disease causing oral plaque biofilm . The rationale that underlies this proposal comes from the many professional associations, such as the American Dental Association, American Dental Hygienists' Association, and the U.S. Department of Health and Human Services, that endorse flossing as an effective home care routine in oral disease prevention. Many oral health professionals would argue that flossing is effective in plaque removal, as they have seen the results anecdotally year after year, yet it is clear that additional studies are needed to move what is known anecdotally to what is known scientifically.

Eligibility criteria: Inclusion Criteria:

* Any persons 18 years of age and able to consent

Exclusion Criteria:

A person being edentulous or who have teeth that do not contact Allergy to erythrosine dye (red #3)

Primary outcomes:
measure: measure removal of oral plaque biofilm
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Universsity of New Mexico
state: New Mexico
Study officials:
References: