louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03112070: Post-Exercise Hypotension After Water Exercise
Official title: Post-Exercise Hypotension After Water Exercise in Older Women With Hypertension: A Randomized Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postexercise Hypotension
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 24
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hypertension is the most prevalent cardiovascular disease risk factor among individuals 60 years of age and older. Hypertension can be prevented and modified with lifestyle interventions that include regular exercise. Water exercise is widely recommended for older adults for a variety of health benefits, but few studies have assessed the immediate ambulatory blood pressure (BP) response to water exercise, a response termed postexercise hypotension (PEH). We will assess PEH after a session of water aerobics in physically active, older women with hypertension. Twenty-four women will be randomly assign to participate in a 45 min session of moderate intensity, water aerobics (WATER) and a 45 min land control session (CONTROL). All experimental sessions will start at 9 am sharply with 7 days between them. Subjects will left the experiments wearing an ambulatory BP monitor for the next 21 hr.


Eligibility criteria: Inclusion Criteria:

* resting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg documented by a physician;
* 65 to 80 years of age;
* physically active on land but not water (exercising 3 or more days per week as determined by the International Physical Activity Questionnaire long-form).

Exclusion Criteria:

* any febrile condition and/or infectious diseases;
* no other chronic diseases or conditions other than hypertension;
* body mass index (BMI) \> 35 kg/m2;
* active smoker;
* physical or mental limitations that prevent exercising.

Primary outcomes:
measure: Blood pressure measurements
timeFrame: 24-hour ambulatory blood pressure monitoring after water exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Alexandre Lehnen
state: Rio Grande do Sul
Study officials:
References:
Clinical trial NCT01559870: Peri-operative Prediction of Prolonged Stay in the Cardiac Intensive Care Unit for Adult Cardiac Surgery
Official title: Peri-operative Prediction of Prolonged Stay in the Cardiac Intensive Care Unit for Adult Cardiac Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
Cytokine Release Syndrome
Keywords: cardiac surgery
cytokine
clinical scoring system
risk factor
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Khon Kaen University
First posted: 2012-03-21
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients who had undergone elective cardiac surgery with CPB

Brief summary: The purpose of this study is to create a model using intra-operative modified SOFA score and peri-operative clinical factors to predict prolonged stay in the cardiac intensive care unit (CICU) for adult cardiac surgery with heart-lung machine

Detailed description: Cardiac surgery using cardiopulmonary bypass (CPB) is commonly associated with a systemic inflammatory response that exacerbates peri-operative life-threatening complications and multiple organ dysfunction syndromes. These features can prolong the stay in the CICU. Many peri-operative clinical risk factors contribute to those adverse outcomes resulting in prolonged CICU stay. If the investigators can create a model to identify the effects of these intra-operative clinical risk factors to prolonged CICU stay

Eligibility criteria: Inclusion Criteria:

* adult patients who had undergone elective cardiac surgery with CPB

Exclusion Criteria:

* under 18 years of age
* needing emergency surgery
* needing intra-aortic balloon pump

Primary outcomes:
measure: Adjusted odds ratio of peri-operative clinical risk factors in prolonged CICU patients
timeFrame: 24 hours after CPB
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Queen Sirikit Heart Cenrter
city: Khon Kaen
country: Thailand
facility: Queen Sirikit Heart Center
Study officials:
References:
Clinical trial NCT05212870: Investıgatıon Of The Effect Of The Pandemıc Process In Indıvıduals Wıth Chronıc Low Back And Neck Paın
Official title: Investıgatıon Of The Effect Of The Pandemıc Process On Cognıtıve Level, Paın Catastrophızatıon, Physıcal Actıvıty Level And Qualıty Of Lıfe In Indıvıduals Wıth Chronıc Low Back And Neck Paın
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Low Back Pain
Cognitive Level
COVID-19 Pandemic
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic low back and neck pain

Brief summary: There are a limited number of studies examining the difficulty of reaching treatment related to the pandemic process and the general effects of the process in patients with chronic low back and neck pain. However, no study has been found that compares the effects of individuals actively carrying and not carrying the Covid-19 virus. For this reason, the aim of the study is to examine the effects of the pandemic process on the cognitive level, pain catastrophization, physical activity level and quality of life in individuals with chronic low back and neck pain.


Eligibility criteria: Inclusion Criteria:

* Those between the ages of 18-60,
* Having low back or neck pain lasting longer than 3 months,
* Having a history of Covid-19 (At least 6 weeks-post acute),
* Individuals with chronic low back and neck pain without a history of Covid-19 will be included.

Exclusion Criteria:

* Those with an active diagnosis of Covid-19
* Having a rheumatological disease,
* Broken etc. severe deformity that may lead to nerve injury,
* Having a history of spinal surgery,
* Having neurological disease in addition to spinal pathology,
* Having problems such as cancer, diabetes, dementia, organic brain dysfunction,
* Illiterate individuals will not be included.

Primary outcomes:
measure: Pain Severity Assessment- Visual Analog Sacle
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Assessment of Cognitive Level: Montreal Cognitive Assessment Scale (MOCA)
timeFrame: 5 minutes, through study completion, an average of 1 year
measure: Evaluation of Pain Catastrophization Level: Pain Catastrophization Scale
timeFrame: 5 minutes, through study completion, an average of 1 year
measure: Assessment of Physical Activity Level: International Physical Activity Questionnaire (UFAA)-Short Form
timeFrame: 5 minutes, through study completion, an average of 1 year
measure: Quality of Life Assessment: SF-36
timeFrame: 5 minutes, through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT03630770: Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Official title: Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Candida Infection
Premature Infant
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Tufts University
First posted: 2018-08-15
Enrollment: 12
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates whether adding a dietary supplement similar to coconut oil (MCT oil) to feedings in premature infants will reduce the amount of yeast (Candida) detectable in their stool. Infants who have Candida in their stool are eligible to participate. Half of the enrolled infants will have additional MCT oil added to their feedings and half will not.


Eligibility criteria: Inclusion Criteria:

* Premature infant admitted to the Neonatal Intensive Care Unit at Women \& Infants Hospital
* Receiving full enteral feeds of either preterm or transitional formula or fortified breast milk
* Anticipated to have a minimum stay of two weeks

Exclusion Criteria:

* Prior exposure to antifungal drugs

Primary outcomes:
measure: Stool Fungal Burden
timeFrame: Before supplementation, 1 week after supplementation begins, 3 weeks (at conclusion of supplementation)
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital of Rhode Island
name: Joseph M Bliss, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gunsalus KT, Tornberg-Belanger SN, Matthan NR, Lichtenstein AH, Kumamoto CA. Manipulation of Host Diet To Reduce Gastrointestinal Colonization by the Opportunistic Pathogen Candida albicans. mSphere. 2015 Nov 18;1(1):e00020-15. doi: 10.1128/mSphere.00020-15. eCollection 2016 Jan-Feb.
citation: Arsenault AB, Gunsalus KTW, Laforce-Nesbitt SS, Przystac L, DeAngelis EJ, Hurley ME, Vorel ES, Tucker R, Matthan NR, Lichtenstein AH, Kumamoto CA, Bliss JM. Dietary Supplementation With Medium-Chain Triglycerides Reduces Candida Gastrointestinal Colonization in Preterm Infants. Pediatr Infect Dis J. 2019 Feb;38(2):164-168. doi: 10.1097/INF.0000000000002042.
Clinical trial NCT06958770: Combining Electrical Impedance Tomography and Thoracic Ultrasound Toinvestigate Dynamic Changes
Official title: Combining Electrical Impedance Tomography and Thoracic Ultrasound to Investigate Dynamic Changes of Respiratory Effort, and Regional & End-expiratory Lung Volume in Mechanically Ventilated Patients.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ARDS (Moderate or Severe)
Keywords: Chest ultrasound
electrical impedance tomography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Admitted into ICU, diagnosed as moderate or severe ARDS (ICD-10-CM: J80) according to Berlin definition.

Brief summary: 1. To evaluate the dynamic changes of lung ultrasound during electrical impedance tomography (EIT) PEEP titration and across the first week of ARDS.
2. To asses respiratory effort by diaphragmatic function, esophageal pressure, and EIT (Pendelluft phenomenon), and hyperinflammatory biomarkers, to predict P-SILI.
3. To develop predictive models for weaning success based on integrated EELI and thoracic ultrasound.


Eligibility criteria: Inclusion Criteria:

* Adult \>18 y/o.
* Patient intubated and receiving mechanical ventilation \> 24 hours.
* Admitted into ICU, diagnosed as moderate or severe ARDS (ICD-10-CM: J80) according to Berlin definition.

Exclusion Criteria:

* Presence of Implanted Electronic Devices (pacemakers, implantable cardioverter-defibrillators).
* Pregnancy.
* No consent/inability to obtain consent and appropriate legal representative not available.

Primary outcomes:
measure: ARDS
timeFrame: From enrollment to the end of treatment at 1 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Yao-Wen Kuo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02598570: Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma
Official title: An Open-Label, Single-Arm, Multicenter Phase 1 Study Evaluating the Safety and Pharmacokinetics of Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Keywords: Relapsed Lymphoma
Phosphoinositide 3-kinase (PI3K) Inhibitor
Duvelisib
Japanese
Refractory Lymphoma
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Infinity Pharmaceuticals, Inc.
First posted: 2015-11-06
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of lymphoma (excluding lymphoblastic lymphoma)
* Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease for which there is no established therapy
* Eastern Cooperative Oncology Group (ECOG) performance status lower than or equal to 2
* Life expectancy of at least 3 months

Exclusion Criteria:

* Any prior treatment with a PI3K inhibitor or Bruton's tyrosine kinase (BTK) inhibitor
* Ongoing treatment with chronic immune-suppressants
* Overt CNS lymphoma
* Inadequate hepatic, bone marrow, or renal function
* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
* Venous thromboembolic event requiring anticoagulation
* Presence of active systemic infection within 72 hours of treatment
* Human immunodeficiency virus (HIV) infection
* Pregnant or lactating women

Primary outcomes:
measure: Number of participants reporting Treatment-emergent Adverse Events
timeFrame: Throughout the study for approximately 2 years
measure: Maximum Observed Plasma Concentration (Cmax) of Duvelisib
timeFrame: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
measure: Time to Maximum Observed Concentration (Tmax) of Duvelisib
timeFrame: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
measure: Area Under the Plasma Concentration-time Curve (AUC) of Duvelisib
timeFrame: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Throughout the study for approximately 2 years
measure: Overall Survival
timeFrame: Throughout the study for approximately 2 years
measure: Progression Free Survival
timeFrame: Throughout the study for approximately 2 years
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 141826
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 141595
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 141594
Study officials:
References:
Clinical trial NCT03712670: Nutraceutical Support With Omega-3
Official title: Treatment of Exudative Age-Related Macular Degeneration With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Disease
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although evidence have clearly proved that intravitreal injection of vascular endothelial growth factor antagonists prevents vision loss and may even improve visual acuity in patients with neovascular AMD, a significant percentage of patients continue to lose visual acuity. Moreover, monthly intravitreal injections represent a burden for society as well as the caregiver.

Combination therapy with either topical 0.1% pranoprofen or nutraceutical support with AREDS2 formula plus omega-3 might act synergistically with intravitreal injection, offering valuable therapeutic support to aflibercept injections in patients requiring long-term treatment.


Eligibility criteria: Inclusion Criteria:

* provision of written informed consent and compliance with study assessments for the full duration of the study
* age \> 40 years
* presence of treatment-naïve neovascular AMD

Exclusion Criteria:

* any previous intravitreal treatment
* previous laser treatment in the study eye
* myopia \> 7 diopters in the study eye
* concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and advanced glaucoma)
* concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal
* known sensitivity to any component of the formulations being investigated.

Primary outcomes:
measure: Central Retinal Thickness (microns)
timeFrame: 12-month
measure: Visual Acuity (LogMAR)
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.
citation: Age-Related Eye Disease Study 2 (AREDS2) Research Group; Chew EY, Clemons TE, Sangiovanni JP, Danis RP, Ferris FL 3rd, Elman MJ, Antoszyk AN, Ruby AJ, Orth D, Bressler SB, Fish GE, Hubbard GB, Klein ML, Chandra SR, Blodi BA, Domalpally A, Friberg T, Wong WT, Rosenfeld PJ, Agron E, Toth CA, Bernstein PS, Sperduto RD. Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No. 3. JAMA Ophthalmol. 2014 Feb;132(2):142-9. doi: 10.1001/jamaophthalmol.2013.7376.
Clinical trial NCT05576870: Growth Study Using Else Toddler Nutritional Drink vs. a. Dairy Based Toddler Drink (Control) in Healthy Toddlers
Official title: Growth Study Using a Toddler Almond Based Nutritional Drink (Test) vs. a. Formula That Has Been Shown to Support Growth (Control) in Healthy Toddlers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Gain
Keywords: toddler
growth
nutrition
Lead sponsor: Else Nutrition GH Ltd
Sponsor class: INDUSTRY
Collaborators: name: Children's Hosptial of Colorado Aurora, Colorado, United States
name: Laina VTMS
First posted: 2022-10-13
Enrollment: 128
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to investigate the growth of healthy toddlers fed with Toddler almond based nutritional drink (test) vs. a. formula that has been shown to support growth (control) in Healthy Toddlers


Eligibility criteria: Inclusion Criteria:

1. Gestational age between ≥37 weeks + 0 days and ≤41 weeks + 6 days,
2. Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
3. Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
4. Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
5. Consuming and tolerating a cow's milk and almond at time of enrollment (at least 3 age appropriate portions)
6. Consuming and tolerating almond on more than one occasion in age appropriated doses, to ensure no reaction to study formula e.g. 2 teaspoons almond butter in one portion or 500 ml/16 fl oz per day

Exclusion Criteria:

1. Toddler with any positive food allergy test food allergy or intolerance to any foods
2. Participants are under ongoing medical care of a pediatrician which according to the parents will make it difficult to complete the study

Primary outcomes:
measure: Weight gain
timeFrame: 4 months
measure: height velocity
timeFrame: 4 months
Secondary outcomes:
measure: Daily intake
timeFrame: 4 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Children's Hospital of Colorado
state: Colorado
Study officials:
References:
Clinical trial NCT02885142: Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anal Cancer
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Local excision for early rectal cancer has proven its feasibility and oncological safety. Indeed, lymph node invasion does not exceed 1% and 10% in pT1sm1 and pT1sm2 rectal carcinomas respectively. Two procedures are currently performed in these early cancers as well as in preneoplastic lesions. Transanal endoscopic microsurgery (TEM), which has proven its superiority over traditional transanal excision, is a surgical approach associated with a 92% R0 excision rate, a survival comparable to radical anterior resection and a low morbidity. It consists of a full-thickness excision. The second procedure is a recently introduced technique: the endoscopic submucosal dissection (ESD), which encompasses only the mucosa and submucosa. ESD enables endoscopists to achieve higher en bloc resection rates than standard mucosectomy and is associated with a 88% R0 resection rate, which decreases to 65% in the subgroup of European series. Though very promising, the role of ESD remains controversial in malignant lesions with few published reports. There are therefore 2 different techniques with 2 different dissections (full-thickness vs. submucosal) to achieve the same oncological treatment. So far, only one retrospective single-center study including 63 patients has compared TEM and ESD in early rectal cancer without finding any difference between the 2 procedures, and there are no other available studies comparing TEM and ESD for any type of colorectal tumor. The aim of the present research is to compare ESD with TEM for early rectal cancer and rectal adenomas for short- and long-term outcomes.


Eligibility criteria: Inclusion Criteria:

* Presenting with an ERT (i.e. rectal adenoma or rectal carcinoma Tis or staged usT1N0 on endorectal ultrasound) that can be alternately resectable by TEM or ESD
* Histology proved by a preoperative biopsy

Exclusion Criteria:

* " Palliative " excision T2/3/4 or N+
* Preoperative radiochemotherapy (down-staging)
* Metastatic cancer
* Pregnant or breast-feeding women

Primary outcomes:
measure: Number of complete excision for TEM compare to number of complete excision for ESD in rectal carcinomas staged usT1N0 and rectal adenomas.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hôpitaux de Marseille
name: Laura BEYER, MD
role: PRINCIPAL_INVESTIGATOR
References: