louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04463407: Effect of a Single Nutritional Intervention Previous to a Critical Period of Fat Gain in University Students With Overweight and Obesity
Official title: Efectividad de Una intervención Educativa Preventiva Previa a Vacaciones de Fiestas Patrias Sobre la composición Corporal, hábitos de alimentación y Niveles de Actividad física en Estudiantes Universitarios: Estudio Aleatorizado Controlado
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Pontificia Universidad Catolica de Valparaiso
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aimed to investigate the effects of a single nutritional preventive session previous to a critical period linked to fat gain in university students with overweight and obesity, emulating a nutritional session of a public health system.


Eligibility criteria: Inclusion Criteria:

* Body mass index \[BMI\] ≥25 kg/m2
* Not having metal plates
* Not studying Nutrition and Dietetics or Physical Education
* Not being pregnant

Exclusion Criteria:

- Presente gastrointestinal problems (vomit or diarrheas) during the three weeks that last the experiment.

Primary outcomes:
measure: Body composition measurements
timeFrame: 3 weeks
Secondary outcomes:
measure: Feeding questionnaires and food guide recommendations
timeFrame: 3 weeks
measure: Feeding questionnaires and food guide recommendations
timeFrame: 3 weeks
measure: Feeding questionnaires and food guide recommendations
timeFrame: 3 weeks
measure: Physical activity level
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Valparaíso
country: Chile
facility: School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile
state: Valparaiso
Study officials:
References:
Clinical trial NCT05777707: Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Esophageal Carcinoma
Official title: Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Locally Advanced Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Esophageal Carcinoma
Neoadjuvant Immunotherapy
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. It also explores predictive biomarkers and potential therapeutic targets for locally advanced esophageal cancer based on plasma metabolomics and peripheral blood immune cell clustering analysis. Each patient received 2-3 cycles of neoadjuvant immunotherapy with programmed cell death 1 (PD-1) blockade in combination with albumin paclitaxel and platinum. Exploratory analysis of plasma metabolomics combined with peripheral blood subsets of immune cells can reveal biomarkers that predict the efficacy and prognosis of patients undergoing neoadjuvant immunotherapy for locally advanced esophageal cancer, which also provide new ideas for the selection of immune adjuvants and therapeutic targets in ICIs combination therapy strategies.


Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years and ≤89 years;
2. pathological histological examination confirmed the diagnosis of esophageal squamous cell carcinoma and esophageal adenocarcinoma;
3. clinical stage II-IVA;
4. adequate organ function;
5. no previous chemotherapy or radiotherapy;
6. voluntarily signed informed consent.

Exclusion Criteria:

1. the presence of concurrent malignancies that interfere with the prognosis of esophageal cancer;
2. patients with immunodeficiency or autoimmune diseases that seriously affect the body's immune system, such as those who test positive for HIV;
3. patients undergoing systemic corticosteroid or other immunosuppressive treatments;
4. patients with a history of allergy to the components of this test drug.

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 24 months
Secondary outcomes:
measure: Pathologic complete remission (PCR)
timeFrame: 4 weeks after surgery
measure: Major Pathologic Response (MPR)
timeFrame: 4 weeks after surgery
measure: Overall survival (OS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Qin li
state: Beijing
Study officials:
References:
Clinical trial NCT05350488: Qualitative Analysis of the Post-Stroke Continuum Among African Stroke Survivors in Alabama
Official title: Qualitative Analysis of the Post-Stroke Continuum Among African Stroke Survivors in Alabama
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke
Disability Physical
Patient Satisfaction
Caregiver Burden
Keywords: Rehabilitation
Post-Stroke Rehabilitation Continuum
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will screen 60-100 individuals with the goal of enrolling a total of 20 AA stroke survivors +/- their identified caregivers. Individuals will be recruited from within the UAB Health System from the acute care neurology stroke service and the PI's stroke recovery clinic. Participants will be separated into 3 groups. Group A will include n=10 participants that are less than 1 year out from their most recent stroke. Group B will include n=10 participants that are greater than 1 year out from their most recent stroke. Group C will include the participants' identified caregivers. Having an available caregiver is preferred but is not required. Therefore, a goal of at least 10 caregivers is set.

Brief summary: This proposal seeks to improve the investigators' post-stroke TOC process through developing an innovative, patient informed and guided solution aimed at addressing the investigators' deep south African American population within the UAB system. The investigators will engage participants in both urban and rural Alabama through informational interviews and work to find common themes to address so that future interventions are useful to their unique needs and desires. This goes beyond simply identifying barriers and endeavors to discovering solutions.


Eligibility criteria: Inclusion Criteria:

1. African American
2. Aged 40 years and older
3. Required home health therapy, outpatient therapy, skilled nursing facility or inpatient rehabilitation
4. Alabama Resident
5. Fluent in English
6. Stroke confirmed by advanced imaging (CT, MRI)
7. Zoom capability (participants can either have video conference ability or can call into Zoom line)
8. Caregivers must be identified by patients as providing a significant portion of care and/or be able to articulate their role as a caregiver

Exclusion Criteria:

1. Did not require home health therapy, outpatient therapy or inpatient rehabilitation
2. Long term residents of skilled nursing facility
3. Severe aphasia
4. Severe cognitive impairments

Primary outcomes:
measure: Feasibility of recruitment and retention
timeFrame: July 1,2022-January 20, 2023
measure: Ability to use Zoom platform
timeFrame: July 1,2022-January 20, 2023
measure: Validity of questions asked to arrive at the themes that will appropriately inform the basis of this proposal
timeFrame: February 2023-May 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01518088: Effects of a Dietary Fiber on Fecal Microbiota and Metabolism
Official title: Effects of a Dietary Fiber on Human Gut Microbiota, Bioactive Metabolites and Blood Glucose Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of the Study is on Gut Health
Lead sponsor: Ingredion Incorporated
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one period, and 30 g per day in the other. In another three-week period, they will consume the same foods, but with no fiber added. Major outcomes will include fermentability of the fiber, as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The caloric value of the fiber will be determined and metabolic measures related to blood glucose control and inflammation will also be taken.


Eligibility criteria: Inclusion Criteria:

* Body mass index from 25 to 35 kg/m2.
* Willing to consume study foods and comply with dietary exclusions and specimen collection

Exclusion Criteria:

* Pregnancy
* Diabetes
* Gastrointestinal disease
* Regular use of pre- or probiotics
* Recent use of antibiotics
* High intake of dietary fiber

Primary outcomes:
measure: Metabolizable energy
timeFrame: 7 days, 3 times
measure: Fermentability
timeFrame: One, eight-hr day, three times
Secondary outcomes:
measure: Fecal microbiota
timeFrame: 2 days, three times, and 7 days, three times
measure: Blood glucose
timeFrame: For eight hours, three times
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA, ARS, Western Human Nutrition Research Center
state: California
Study officials:
affiliation: ARS/USDA, University of California - Davis
name: Nancy Keim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03700788: 2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament
Official title: Use of 2% Chlorhexidine (CHX) as Intracanal Medicament in Endodontic Emergencies and to Compare Its Use and Effectiveness With CaOH2 (CH) Calcium Hydroxide Paste
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Apical Periodontitis
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Pilot Phase III single-blind randomized controlled clinical trial in patients, aged 18 years and older, presenting with symptoms of apical periodontitis. The overall goal is to assess whether 2% Chlorhexidine (CHX) is superior to Calcium Hydroxide in reducing interappointment pain.

Detailed description: This is a Pilot Phase III single-blind randomized controlled clinical trial in patients, aged 18 years and older, presenting with symptoms of apical periodontitis. Patients will be treated with one of two current clinically-used medications, 2% chlorohexidine (intervention) vs. calcium hydroxide (standard-of-care). One week following treatment (+/- 2 days), patients will return for reevaltuion of apical periodontitis symptoms, via patient's pain perception after a bite test.

The primary objective of the proposed study is to determine if there is a difference in 7-day (+/- 2) post-procedure apical periodontitis following randomization to either 2% chlorohexidine vs. calcium hydroxide paste among patients presenting with symptoms of apical periodontitis. Additionally, the investigators will assess the number of adverse events that occur in each treatment group to determine if there appears to be a difference across groups, descriptively.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* symptomatic apical periodontitis (positive to the bite test)
* restorable tooth
* requires root canal therapy
* able to undergo informed consent process
* must be English or Spanish speaker

Exclusion Criteria:

* Cracked tooth
* non-restorable tooth
* no pain medication or antibiotic taken in the past 3 days

Primary outcomes:
measure: 2% Chlorhexidine (CHX) vs CaOH2 (CH) Calcium Hydroxide Paste as an Intracanal Medicament.
timeFrame: 7 days (+/- 2 days) post treatment
Secondary outcomes:
measure: Is 2% Chlorhexidine (CHX) better than Calcium Hydroxide in terms of producing fewer adverse events?
timeFrame: 7 days (+/- 2 days) post treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Herman Ostrow USC School of Dentistry
state: California
Study officials:
affiliation: Director, Advanced Endodontics
name: Rafael Roges, D.D.S.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05561088: Efficacy and Safety of Head Acupuncture After Mechanical Thrombectomy for Acute Ischemic Stroke
Official title: A Single-center, Prospective, Randomized, Controlled Study of Mechanical Thrombectomy Followed by Acupuncture for Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acupuncture
Acute Ischemic Stroke
Mechanical Thrombectomy
Lead sponsor: Xi'an No.3 Hospital
Sponsor class: OTHER_GOV
First posted: 2022-09-30
Enrollment: 272
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: TREATMENT

Brief summary: To evaluate the efficacy and safety of head acupuncture combined with endovascular therapy for cerebral infarction compared with endovascular therapy alone

Detailed description: Control group: Mechanical thrombectomy followed by the guideline recommended treatment for acute ischemic stroke;

Experimental group: After mechanical thrombectomy, head acupuncture and the treatment regimen recommended by the guideline for acute ischemic stroke were administered

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years;
* Patients with acute ischemic stroke who received endovascular treatment within 24 hours of onset;
* 6 \< NIHSS ≤25;
* ASPECT score ≥6 points;
* Signed Informed consent.

Exclusion Criteria:

* CT or brain MRI confirmed intracranial tumor and intracranial hemorrhage;
* Contraindications of contrast media;
* Dementia or mental illness，unable to cooperate with treatment and follow-up;
* The expected survival time was less than 3 months;
* Women who are pregnant, planning to become pregnant or breastfeeding;
* Currently participating in other clinical trials.

Primary outcomes:
measure: Ratio of Modified rankin scale (mRS) score ≤2
timeFrame: 90 days after onset
Secondary outcomes:
measure: National Institute of Health stroke scale(NIHSS) score
timeFrame: 10 days after onset
measure: Modified rankin scale (mRS) score
timeFrame: 90 days after onset
measure: Incidence of cerebral hemorrhage
timeFrame: 7 days after randomization
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi 'an No.3 Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT06798688: In This Study, the Sponsor Would Like to Collaborate with Institution and Investigator to Aggregate Participants Data and to Pilot Its Software Algorithm Using Machine Learning and Threshold Based Methods for Predicting Exacerbations and Deterioration Within a 60 Days Period Post-discharge
Official title: Software Algorithm Using Machine Learning and Threshold Based Methods for Predicting Exacerbations and Deterioration
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD
Lead sponsor: Respiree Pte Ltd
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The enrolment goal is 20 participants with at least 2 documented exacerbations in the past 12 months for a period of 8 weeks each. In addition to the baseline visit and Study on-boarding, there will be 2 follow-ups every month. Participants will be enrolled at discharge (and not designate hospital or ED).

Brief summary: In this study, the sponsor would like to collaborate with Institution and Investigator to aggregate participants data and to pilot its software algorithm using machine learning and threshold based methods for predicting exacerbations and deterioration within a 60 days period post-discharge.


Eligibility criteria: Inclusion Criteria:

1. Subject age 18 or older
2. Receives all primary and specialty care at Institution
3. Participants will be enrolled at discharge (and not designate hospital or ED)
4. A history of one of the following diagnoses:

   a. c. Chronic obstructive pulmonary disease
5. At least two documented exacerbations of the above disease in the past 12 months as defined by the following corresponding criteria:

   a. Chronic obstructive pulmonary disease exacerbation: all three of (1) increase in frequency and severity or severity of cough, (2) increase in volume and/or change of character of sputum production, and (3) increase in dyspnea, and requiring treatment with short-acting bronchodilators, antibiotics, and oral or intravenous glucocorticoids.
6. Participants able to provide informed consent.
7. Participants will be enrolled at discharge (and not designate hospital or ED)

Exclusion Criteria:

1. Participants with neuromuscular diseases and seizures
2. Participants enrolled in hospice care or life expectancy less than three months.
3. Participants living more than 60 miles away from Institution and Investigator
4. Participants with expected out of state travel within a 30-day period or travel to a location with no internet access.

Primary outcomes:
measure: Identifying readmissions using respiratory biomarkers
timeFrame: 60-days
Secondary outcomes:
measure: Validate compliance and usability
timeFrame: 60-days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01414088: The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers in Healthy Young Subjects
Official title: The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers for the Measurement of Sodium and Water Channel Activity in the Nephron in Healthy Young Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephropathy
Keywords: Nephrology
ENaC
NCC
NKCC
Sodium channels
renal biomarkers
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The kidneys have numerous salt and water channels and play a major role in the regulation of sodium and water. We do not know how these channels work in certain water and sodium accumulating medical conditions.

The purpose of this study is to identify and measure the activity in the water and sodium channels by measuring urine biomarkers/proteins in young healthy subjects.

Detailed description: 25 healthy subjects from age 18-45 are recruited.

Subjects will be examined on three examination days. Four days prior to the examination days the subjects will consume a standard diet based on the amount of sodium and calories.

On the examination day subjects are randomised to an infusion with either isotonic saline 23 ml/kg, hypertonic saline 7 ml/kg or glucose 23 ml/kg for a period of 50 minutes.

Renal function is measured by renal clearance of 51Cr-EDTA, urinary sodium, potassium and creatinine.

Urinary NCC, NKCC and ENAC will be measured to evaluate the activity of sodium channels in the nephron.

Eligibility criteria: Inclusion Criteria:

* healthy males and females
* age 18-45
* BMI range 18,5-30,0 kg/m2

Exclusion Criteria:

* hypertension (ie ambulatory BP \>130 mmHg systolic or/and \>80 mmHg diastolic)
* history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic disease.
* alcohol abuse
* drug abuse
* smoking
* pregnancy or nursing
* blood donation within a month prior to examination
* Medical treatment apart from oral contraception

Primary outcomes:
measure: Renal biomarkers
timeFrame: day one
Secondary outcomes:
measure: blood hormones regulating salt, water and blood pressure
timeFrame: day one
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Medicinsk Forskning, Regionshospitalet i Holstebro
Study officials:
affiliation: Medicinsk Forskning, Regionshospitalet i Holstebro
name: Erling B Pedersen, Professor
role: STUDY_DIRECTOR
References:
citation: Jensen JM, Mose FH, Bech JN, Nielsen S, Pedersen EB. Effect of volume expansion with hypertonic- and isotonic saline and isotonic glucose on sodium and water transport in the principal cells in the kidney. BMC Nephrol. 2013 Sep 26;14:202. doi: 10.1186/1471-2369-14-202.
Clinical trial NCT02673788: Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage
Official title: Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Hemorrhages
Mesenchymal Stem Cells
Newborn Infant
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 9
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paitents who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.

Brief summary: This is a follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Patients who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.

Exclusion Criteria:

* Patients who did not enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.

Primary outcomes:
measure: newly developed brain tumor
timeFrame: until 2 years old (corrected age)
Secondary outcomes:
measure: Bayley score (MDI, PDI)
timeFrame: until 2 years old (corrected age)
measure: Cerebral palsy
timeFrame: until 2 years old (corrected age)
measure: Developmental disability
timeFrame: until 2 years old (corrected age)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: