louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05855837: Appetite Responses to Cereal Products
Official title: Appetite Responses to Cereal Products: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction, Consumer
Lead sponsor: General Mills
Sponsor class: INDUSTRY
First posted: 2023-05-12
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this clinical trial is to investigate appetite responses to 2 cereal products in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-70 years old
* Habitual cereal consumers (at least several times per month)
* Body mass index 18.5-24.9 kg/m2 (based on self-reported weight and height
* Understand and willing to follow the study procedures
* Willing to drink skim milk
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the study
* Willing to abstain from strenuous exercise and consuming alcoholic drinks 24 hours before the test day
* Willing to provide Informed Consent to participate in the study

Exclusion Criteria:

* Pregnant or lactating women, or women who are planning to become pregnant during the study
* Known food allergies, sensitivities, or intolerance to any food or food ingredients
* Participation in another clinical trial for food, investigational drug, nutritional supplement, or lifestyle modification
* Taking medication(s) that affect appetite, metabolism or blood pressure
* Presence of acute diseases or infection
* Presence or history of chronic diseases
* Diagnosed with an eating disorder
* Restraint eaters as determined by score \>4 from the Dutch Eating Behavior Questionnaire
* Lost or gained 5 or more pounds in the past 3 months
* On a weight loss diet or undergoing intermittent fasting
* COVID-19 infection within the past 3 months
* Subjects who do not eat cereal products

Primary outcomes:
measure: Visual Analogue Scale for Hunger 0-240 minutes
timeFrame: 240 minutes
measure: Visual Analogue Scale for Fullness 0-240 minutes
timeFrame: 240 min
measure: Visual Analogue Scale for Satiation 0-240 minutes
timeFrame: 0-240 min
measure: Visual Analogue Scale for Desire to Eat 0-240 minutes
timeFrame: 240 min
measure: Visual Analogue Scale for Prospective Consumption 0-240 minutes
timeFrame: 240 min
measure: Visual Analogue Scale for Satisfaction 0-240 minutes
timeFrame: 240 min
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Remote study, no physical facility
state: Minnesota
Study officials:
References:
Clinical trial NCT00241137: A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg
Official title: A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 3790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this was to evaluate valsartan 320mg compared to valsartan 160 mg in terms of blood pressure reduction in a patient population of mild to moderate hypertensives


Eligibility criteria: Inclusion Criteria:

* • Male or female age between 18-80 years of age, inclusive

  * Diagnosed at enrollment (visits 2) to be mild to moderate hypertensive with a MSDBP \>= 95 and =\< 109 mmHg for non treated patients.
  * Previously treated patients should have a MSDBP =\< 109 mmHg at visit 1 and a MSDBP \>= 95 and =\< 109 mmHg at visit 2.
  * Written informed consent to participate in the study prior to any study procedures
  * Ability to communicate and comply with all study requirements

Exclusion Criteria:

* Severe hypertension (grade 3 of WHO classification; \>= 110 mmHg diastolic and/or \>= 180 mmHg systolic).
* Malignant hypertension
* Inability to discontinue all prior anti-hypertensive medications safely for a period of 2 weeks, as required by the protocol.
* Known history of proteinuria (greater than 0.3 gram per day)
* Female patients who are not either post-menopausal for one year or surgically sterile, and who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Oral contraceptive use is not allowed.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 1.
* Transient ischemic cerebral attack during the last 12 months prior to Visit 1.

Primary outcomes:
measure: Change from baseline diastolic blood pressure after 4 weeks
Secondary outcomes:
measure: Change from baseline systolic blood pressure after 4 weeks
measure: Change from baseline diastolic and systolic blood pressure in patients with a diastolic blood pressure greater than or equal to 90 mmHg at randomization after 4 weeks
measure: Adverse events and serious adverse events at each study visit for 4 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceutical
role: STUDY_DIRECTOR
References:
Clinical trial NCT02429037: P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer
Official title: Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomized Phase 2 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Head and Neck Cancer
Keywords: p53
gene therapy
head and neck cancer
Lead sponsor: Shenzhen SiBiono GeneTech Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2015-04-29
Enrollment: 60
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 objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.

Detailed description: To evaluate benefits of rAd-p53) gene therapy combined with radio- and chemo-therapy in treatment of unresectable, locally advanced head and neck cancer, total of 60 patients with above condition will be randomly assigned to two groups: the experiment group (EG) and the control group (CG). The EG received multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10\^12 viral particles (VP) in a 21-days cycle. Both EG and CG were given radiotherapy at a total dose of 60 Gy and chemotherapy (Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15). The patients will be treated until disease progression, withdrawal from study, or untolerated adverse events. study endpoints are efficacy (Progression-free survival, overall survival) and safety variables.

Eligibility criteria: Inclusion Criteria:

1. histopathologically diagnosed head and neck cancer;
2. unresectable, locally advanced;
3. 18 years or older;
4. with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;
5. with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.

Exclusion Criteria:

1. Serious blood coagulation disorder, bleeding tendency, platelet \< 6 \* 1000000000/L;
2. have serious heart, lung function abnormalities or severe diabetes patients;
3. active infection;
4. severe atherosclerosis;
5. AIDS patients;
6. serious thrombotic or embolic events within 6 months;
7. renal insufficiency requiring hemodialysis or peritoneal dialysis;
8. pregnant or lactating women;
9. mental disorder or disease.

Primary outcomes:
measure: progression-free survival
timeFrame: three years after starting treatment
Secondary outcomes:
measure: Adverse events
timeFrame: from starting study treatment until 30 days after the last study treatment
measure: overall survival
timeFrame: three years after starting study treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu cancer hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT06279637: Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes
Official title: Joint Patient and Caregiver Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (Joint Home-DM-BAT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.

The aims of the study are:

Aim 1: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).

Aim 2: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) Joint Home DM-BAT on patient quality of life.

Aim 3: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on caregiver quality of life and caregiver burden.


Eligibility criteria: Patient Inclusion Criteria:

1. Age ≥50 years of age;
2. Self-identified as Black/African American;
3. Clinical diagnosis of T2DM and poorly controlled, defined as HbA1c ≥8% at the screening visit;
4. Able to communicate in English; and
5. Has an informal caregiver (family member or close friend willing to participate in the study for 6 months.

Caregiver Inclusion Criteria:

1. Willing to attend 4, one-hour sessions with the study participant;
2. Willing to support the study participant for study duration (6 months); and
3. Willing to complete brief baseline, 3- and 6-month assessments.

Patient/Caregiver Exclusion Criteria:

1. Mental confusion at screening assessment suggesting significant dementia;
2. Alcohol or drug abuse/dependency at screening assessment;
3. Active psychosis or acute mental disorder at screening assessment; and
4. Life expectancy \<6 months at screening.

Primary outcomes:
measure: Glycemic Control (Hemoglobin A1C [HbA1C])
timeFrame: Change in baseline HbA1C at 6 months post intervention follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT02210637: Non Attendance at Scheduled Appointments as a Marker of Mortality and Hospital Admission
Official title: Non Attendance at Scheduled Appointments as a Marker of Visits in the Emergency Department, Hospitalization and Mortality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Appointments and Schedules
Outpatient Clinics, Hospital/Economics
Emergency Department
Hospitalization
Mortality
Keywords: Appointments and Schedules
Outpatient Clinics, Hospital/Economics
Emergency Department
Hospitalization
Mortality
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 177083
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We included all requested appointments (random consecutive sampling) between 2012 and 2013 (24 month).

Brief summary: To evaluate the association of non attendance at scheduled appointments with visits in the emergency department, hospitalizations and mortality during one year follow up.

Detailed description: Nonattendance at scheduled appointments at outpatient clinics is a common problem in general medical practice, representing a significant cost to the health care system, and resulting in disruption of daily work planning.Nonattendance at medical appointments has consequences not only for doctors (as it requires a greater use of resources and time), but also for patients, because there may be deterioration in the quality of care, and dissatisfaction associated with delays in obtaining a new appointment

Eligibility criteria: Inclusion Criteria:

* Over 17 years.
* Adults who attended, did not attend a scheduled appointment at the Outpatient care system at the Italian Hospital of Buenos Aires (HIBA)

Exclusion Criteria:

- The refusal to register or to the informed consent process.

Primary outcomes:
measure: All cause mortality
timeFrame: 1 year
Secondary outcomes:
measure: All cause unprogrammed consult to the emergency department
timeFrame: 1 year
measure: All cause unprogrammed admissions to hospital
timeFrame: 1 year
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Capital Federal
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Diego H Giunta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03062137: Finding the Optimal Location for Saturation Measurement During Flexible Bronchoscopy
Official title: Optimal Location of Saturation Measurement During Flexible Fiberoptic Bronchoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Desaturation of Blood
Keywords: bronchoscopy
saturation
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients, adults, undergoing Flexible Fiberoptic Bronchoscopy under sedation

Brief summary: An observational comparison of different locations of saturation measurements during Flexible Bronchoscopy

Detailed description: The study group will include 100 patients undergoing flexible fiberoptic bronchoscopy (FFB).

The patients will receive sedation with Midazolam, Fentanyl and Propofol. All patients will receive supplemental oxygen via nasal cannula (2-4 L/min) before the beginning of the procedure.

In all cases, patients will be monitored using continuous electrocardiography, pulse oximetry (on patients finger), and transcutaneous carbon dioxide and saturation (on patients earlobe), and automated noninvasive blood pressure recordings every 5 minutes. All parameters will be recorded from accepting patient to bed of procedure until 10 minutes after removal of FFB from nasopharynx.

The saturation will be measured in 3 different locations (one pulse is added in other earlobe). additionally, A blood gas sample will be taken during discrepancy between different measurements.

Immediately after the end of procedure, the measurements from 3 different monitors will be printed, and the blood sample be taken to a gas sample machine by the investigator.

Desaturation value and time will be compared between the different locations. The blood arterial saturation will be compared to other measurements taken at the same time.

Eligibility criteria: Inclusion Criteria:

* informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Value changes between locations
timeFrame: Through completion of bronchoscopy procedure an average of 30 minutes
measure: Time changes between locations
timeFrame: Through completion of bronchoscopy procedure an average of 30 minutes
Secondary outcomes:
measure: gap between arterial gas sample and different monitors
timeFrame: Through completion of bronchoscopy procedure an average of 30 minutes
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Pulmonary Institute Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center, Belinson Hospital
name: Mordechai R Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00352937: Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test
Official title: Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Arteriosclerosis
Keywords: Coronary Arteriosclerosis
Tomography, X-Ray Computed
Tomography, Emission-Computed, Single-Photon
Lead sponsor: Providence VA Medical Center
Sponsor class: FED
First posted: 2006-07-17
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients without prior CAD referred for nuclear stress testing

Brief summary: To compare the efficacy of 16-row multi-detector CT (MDCT) with standard myocardial perfusion imaging in detecting coronary artery disease (CAD) in patients without a previously established diagnosis of CAD.

Detailed description: Nuclear stress testing is currently the established non-invasive modality in detecting flow-obstructing coronary artery disease (CAD).

Recently, multi-detector CT (MDCT) has emerged as a new modality that offers a non-invasive means to directly visualize coronary anatomy and any CAD. Studies have shown that MDCT has excellent sensitivity and a high negative predictive value in detecting significant CAD.

The purpose of this study is to compare MDCT with nuclear stress testing for detecting CAD in previously undiagnosed patients.

Eligibility criteria: Inclusion Criteria:

* Referred for a clinical indicated stress SPECT MPI
* Adequate IV access in both arms

Exclusion Criteria:

* History of coronary angioplasty or stent placement
* History of coronary bypass surgery
* Angiographic history of flow-limiting CAD
* Documented history of elevated cardiac markers
* Documented history of injury or infarct on ECG
* Absence of sinus rhythm
* Current history of renal insufficiency
* Known allergy to contrast dye
* Pregnant

Primary outcomes:
measure: Calcium score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence Veterans Affairs Medical Center
state: Rhode Island
Study officials:
affiliation: Providence VAMC
name: Wen-Chih Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence VAMC
name: Victor H Shin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03557437: High Dose of Amoxicillin and Metronidazole Plus Bismuth For Helicobacter Pylori Treatment
Official title: Efficacy of High Dose of Amoxicillin And Metronidazole Plus Bismuth For Helicobacter Pylori Treatment In Naive Patients : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori Therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Amoxicillin and metronidazole （400mg Q.D.S） based quadruple therapy had achieved a high cure rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate the efficacy and safety of the amoxicillin and metronidazole (400mg thrice a day) based triple therapy and the addition of bismuth in the naive patients with helicobacter pylori infection.


Eligibility criteria: Inclusion Criteria:

* Participants with non-ulcer functional dyspepsia or peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with no previous treatment experience

Exclusion Criteria:

* Less than 18 years old
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Within 7 days after completion of therapy
measure: Compliance rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Hong Lu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo L, Ji Y, Yu L, Huang Y, Liang X, Graham DY, Lu H. 14-Day High-Dose Amoxicillin- and Metronidazole-Containing Triple Therapy With or Without Bismuth as First-Line Helicobacter pylori Treatment. Dig Dis Sci. 2020 Dec;65(12):3639-3646. doi: 10.1007/s10620-020-06115-7. Epub 2020 Feb 4.
Clinical trial NCT00818337: Aspirin Responsiveness in Women at Risk for Cardiac Events
Official title: Aspirin Responsiveness in Women at Risk for Cardiac Events: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Disease
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2009-01-07
Enrollment: 36
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this pilot study is to evaluate the prevalence of biological aspirin resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then re-tested for aspirin responsiveness.


Eligibility criteria: Inclusion Criteria:

* Women at least 19 years old
* Taking 81 mg aspirin daily, non-enteric coated, for at least one month for the primary prevention of cardiovascular disease.
* Able and willing to provide informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* Known CHD
* Currently taking clopidogrel or ticlopidine
* Use of heparin, warfarin, or glycoprotein IIb/IIIa inhibitors within previous 96 hours
* Allergy or hypersensitivity to salicylates
* Use of other OTC or prescription analgesics or anti-inflammatory medication in the past two weeks
* Currently participating in another investigational drug or device study

Primary outcomes:
measure: Number of Women Aspirin Resistant
timeFrame: Baseline
Secondary outcomes:
measure: Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: The Cardiac Center at Creighton University
state: Nebraska
Study officials:
References: