louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01483495: Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry: a Pilot Study
Official title: Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia-Ischemia, Brain
Signs and Symptoms
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2011-12-01
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective surgery

Brief summary: The brain is such a metabolically active organ that it consumes about 20% of oxygen burned every minute by an average adult even though it only contributes about 2% of the body weight. As a result, the brain produces a disproportionately high amount of CO2 every minute in comparison with the rest of the body.

Detailed description: The researcher can use Diffuse Optical Spectroscopy Imaging, cerebral non-invasive oximetry instrument, to determine cerebrovascular reactivity during surgery procedure. Specifically, the cerebral tissue O2 saturation can measure by Diffuse Optical Spectroscopy Imaging can use for cerebral blood flow in the evaluation of cerebrovascular reactivity.

Adequate brain perfusion is critical not only to supply oxygen and nutrients but also to wash out metabolic end products including CO2. Blood flow depends on perfusion pressure and vascular bed resistance. It is well known that multiple physiological and pathological factors affect cerebral vasculature, and the resistance to blood flow. The cerebrovascular responsiveness to those factors determines how well the brain can maintain and adjust its perfusion.

Eligibility criteria: Inclusion Criteria:

1. Male or Female 20 years of age and older
2. Female non-pregnant
3. Subject scheduled for elective surgery under general anesthesia with intubation.
4. Subject who is able to give informed consent.

Exclusion Criteria:

1. Less than 20 years old of age
2. Pregnant woman
3. Subjects currently diagnosed with severe hypertension, myocardial ischemic disease, symptomatic valvular disease(s), symptomatic arrhythmia, uncompensated congestive heart failure, intracranial aneurysm.

Primary outcomes:
measure: Brain blood flow
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI Beckman Laser Institute
state: California
Study officials:
affiliation: Beckman Laser Institute
name: Bruce Tromberg, PhD
role: STUDY_DIRECTOR
affiliation: Anesthesiology Perioperative Care
name: Lingzhong Meng, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06804395: CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management
Official title: CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Risk
Keywords: Cancer Prevention
Cancer Risk
Cancer Early Detection
Cancer High Risk
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are at risk for cancer or who have taken the Hennessy Institute cancer risk assessment (I.e participated in their cancer prevention program)

Brief summary: Early diagnosis of cancer allows for better treatment outcomes, higher survival rates, and lower costs of care. It is shown that cancer monitoring for cancer in at-risk populations is a key component in early diagnosis. The HMH Hennessey Institute for Cancer prevention and Applied Molecular Science (HICAP) is a newly founded institute, providing clinical services for cancer screening and risk assessment to the community, as well as research in cancer risk and prevention. The CanScan registry will prospectively collect data from participants in the form of questionnaires. The registry will also capture data that is collected as per non-research assessments, for participants who consent to participate. The registry will facilitate better understanding of cancer risk, screening, and diagnostics.


Eligibility criteria: * Adults ( 18 and older)
* Ability to provide own consent
* Must meet at least one of the below criteria, Indicating an increased risk for cancer, any of the following:

  * Family or personal history suggests a familial/hereditary disorder known or suspected of predisposition to cancer.
  * Personal factors associated with an increased risk for cancer include benign breast disease, polyps, tobacco use, etc.as defined by the investigator.
  * Family members of participating individuals.
* Any participant in the HICAP program regardless of cancer risk

Primary outcomes:
measure: Rate of Pathogenic Germline Variants (PGV)
timeFrame: 10 years from study initiation as defined based on the date the first patient was enrolled.
Secondary outcomes:
measure: Incidence of Cancer
timeFrame: 10 years from study enrollment.
measure: Genetic Risk Score (GRS)
timeFrame: 10 years from study enrollment
measure: Environmental and Lifestyle Factors
timeFrame: 10 years from study enrollment
measure: Impact of Early Detection and Prevention on Cancer Outcomes
timeFrame: 10 years from study enrollment
Other outcomes:
Locations:
city: Totowa
country: United States
facility: Hennessy Institute for Cancer Prevention and Applied Molecular Medicine
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Elias Obeid, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04613895: Treatment Effect According to Timing of Administration of DWP14012 40 mg
Official title: A Multi-Center, Open-label, Randomized Trial to Evaluate the Efficacy and Safety Based on Timing of Administration of DWP14012 in Patients With Erosive Esophagitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erosive Esophagitis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
Collaborators: name: Hanyang University
First posted: 2020-11-03
Enrollment: 186
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.

Detailed description: Subjects will provide written informed consent for study participation and then undergo appropriate screening. Subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to either before meal group or after meal group. Subjects will be stratified into two groups according to Los Angeles classification grades (LA grades) A/B or C/D, as determined by upper gastrointestinal (GI) endoscopy. Subjects will visit the site at Week 2 for endoscopic assessment. Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment. Subjects whose mucosal breaks have not healed will continue to receive IPs for an additional 2 weeks and will visit the site for endoscopic assessment at Week 4.

Eligibility criteria: Inclusion Criteria:

* Adults between 19 and 75 years old based on the date of written agreement
* Those who have been diagnosed with erosive esophagitis of LA Grade A-D on the upper gastrointestinal endoscopy
* Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days

Exclusion Criteria:

* Those who have undergone gastric acid suppression or gastric, esophageal surgery
* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease

Primary outcomes:
measure: healing rate at 4 week
timeFrame: 4 week
Secondary outcomes:
measure: healing rate at 2 week
timeFrame: 2 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
Study officials:
References:
Clinical trial NCT00738855: Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO)
Official title: Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small Bowel Obstruction
Keywords: Adhesions
Oral contrast
Exploration
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2008-08-21
Enrollment: 100
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: Mini abstract :

Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups. Eight episodes in eight patients were excluded. Gastrografin group showed a significant decrease of both the time between admission and operation and that of hospital stay .The need for surgery was reduced but statistically insignificant.

Detailed description: Abstract

Background:

Many published studies have shown that Gastrografin can be used for diagnosis post operative acute small bowel obstruction (ASBO) and assessing the need for surgical intervention .However,the studies have reported conflicting results hence the aim of our study to test this hypothesis.

Patients and methods :

Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups in a double blinded fashion. Eight episodes in eight patients were excluded due to protocol violation. In Gastrografin group,100 ml of the dye administered through a nasogastric tube and complete obstruction has been considered if the contrast failed to reach the colon on the 24-hour film. Patients were operated on only if they developed signs of strangulation or failed to improve within 48 hours.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to our surgical department by postoperative SBO were considered for inclusion in this trial.

Exclusion Criteria:

* Age less than 18 years
* Large bowel obstruction
* Recent (within 4 weeks) abdominal surgery
* Ileus
* Cancer peritonitis
* Peritonitis
* Strangulation symptoms and signs
* Obstructed abdominal wall or groin hernia
* Subtotal or total colectomy
* All patients in whom the final diagnosis was not SBO

Primary outcomes:
measure: resolving
timeFrame: 48 hours
Secondary outcomes:
measure: non resolving
timeFrame: 48 hours
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
affiliation: Mansoura University Hospital
name: amir fikry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University Hospital
name: ayman mohamed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01331655: Clinical Study of a Conventional and Flexible Extended Oral Contraceptive of EE/DRSP With or Without Metafolin in Latin America
Official title: A Multicenter, Open-label, 3-arm, Active-controlled, Parallel-group, 1-year Study to Investigate the Efficacy and Safety of a Flexible Regimen of the Combined Oral Contraceptive, With and Without 0.451 mg Levomefolate Calcium (BAY98-7071 and BAY86-5300, Respectively) Versus the Standard 24 + 4 Regimen With Levomefolate (BAY98-7071 + BAY86-7660) and to Assess Compliance With a Device (CADDY) in Healthy Women Who Desire Contraception
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this three-arm study is to evaluate the effect of a flexible extended regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance with daily pill intake when the investigational product is provided in a blister package or a compliance aiding dispenser with a pill reminder function. The third treatment arm will be a reference comparator arm of a standard 24+4 regimen of the identical hormone combination.


Eligibility criteria: Inclusion Criteria:

* Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection

Exclusion Criteria:

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
* Body mass index (BMI) \>/= 30.0 kg/m2
* Presence or a history of venous or arterial thrombotic/thromboembolic events
* Repeated measurements of systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg
* Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous combined oral contraceptive (COC) use
* Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
* Severe dyslipoproteinemia
* Malignant or premalignant disease
* Uncontrolled thyroid disorder
* Chronic inflammatory bowel disease

Primary outcomes:
measure: Number of bleeding days
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Difference in the number of missed tablets between Arms A and B
timeFrame: Approximately 1 year
measure: Bleeding pattern and cycle control parameters
timeFrame: Approximately 1 year
measure: Number of cycles per subject
timeFrame: Approximately 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02231255: Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease
Official title: Switch Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 1216
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Idiopathic Parkinson's disease patients recruited at office-based neurologists, psychiatrist or special neurology clinics

Brief summary: Documentation of the effect of an direct or overlapping switch from another dopamine agonist to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions


Eligibility criteria: Inclusion Criteria:

* Patients with Idiopathic Parkinson's disease who are planned to undergo a switch from another dopamine agonist to Sifrol®

Exclusion Criteria:

* Neurologists and psychiatrists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®

Primary outcomes:
measure: Reason for switch of therapy and reason for using Sifrol®
timeFrame: up to 8 weeks
measure: Type of switch (abrupt or overlapping)
timeFrame: up to 8 weeks
measure: Changes in motor function by means of 5-points rating scale
timeFrame: up to 8 weeks
measure: Changes in psychopathological memory disturbances by means of 5- point rating scale
timeFrame: up to 8 weeks
measure: Changes in psychopathological thought disorder disturbances by means of 5- point rating scale
timeFrame: up to 8 weeks
measure: Changes in psychopathological depression disturbances by means of 5- point rating scale
timeFrame: up to 8 weeks
measure: Changes of mood on seven visual analogue scales (VASs)
timeFrame: up to 8 weeks
measure: Equivalent doses of Sifrol®
timeFrame: after 8 weeks
measure: Global assessment of efficacy by investigator on a 5-point rating scale
timeFrame: after 8 weeks
Secondary outcomes:
measure: Number of patients with adverse drug reactions
timeFrame: up to 8 weeks
measure: Assessment of tolerability by investigator on a 5-point rating scale
timeFrame: after 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01657955: Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia
Official title: Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Leukemia
Neoplasms
Lead sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether bendamustine is effective in the treatment of initial treatment of Chronic Lymphocytic Leukemia (CLL).


Eligibility criteria: Inclusion Criteria:

* Patients must have a diagnosis of CLL;
* No prior or no standard treatment for CLL;
* Binet stage B, C or symptomatic stage A;
* Needs treatment to control diseases;
* (Eastern Cooperative Oncology Group)ECOG performance status ≤ 2
* Life expectancy ≥3 months
* Written informed consent

Exclusion Criteria:

* Patients were diagnosed with or treated for malignant tumors other than CLL (including active central nervous system lymphoma) within one year prior to entering the study
* Transformation to Richter's syndrome, or prolymphocytic leukemia(PLL)
* Autoimmune hemolytic anemia requiring glucocorticoid therapy
* Autoimmune thrombocytopenia requiring glucocorticoid therapy
* Alanine aminotransferase(ALT)\>3 times upper limits of normal value, Aspartate aminotransferase(AST)\>3 times upper limits of normal value, Total bilirubin(TBIL)\>2 times upper limits of normal value, serum creatinine\>1.5 times upper limits of normal value;
* Other serious Concomitant diseases which affect participation of this study(uncontrolled diabetes, gastric ulcer, cardiac and pulmonary diseases, at active phases of autoimmune diseases;
* Serious or uncontrolled infections;
* Central nervous system dysfunction with clinical symptoms;
* Patients received major surgery within 30 days prior to study entry;
* Pregnant or lactating women
* Allergic to study drug or mannitol
* Participation in any other clinical trials within 3 months prior to study entry

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 24 months
Secondary outcomes:
measure: Progress free survival(PFS)
timeFrame: 24 months
measure: Duration of Response (DR)
timeFrame: 24 months
measure: Overall Survival(OS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Hematologic hospital of Chinese academy of medical sciences
Study officials:
affiliation: Hematologic Hospital of Chinese Academy of Medical Sciences
name: Lu G Qiu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03968055: Remote Monitoring of CGM Data in Pediatric Patients with Newly Diagnosed Type 1 Diabetes (T1D)
Official title: The Use of Continuous Glucose Monitor Technology and Remote Monitoring to Change Clinical Outcomes Following New Diagnosis of Type 1 Diabetes in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 1 Diabetes
Keywords: pediatrics
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine if increased targeted contact between patients and the care team can improve diabetes outcomes in the 1st year after diagnosis. We will be using the GluVue platform to remotely view continuous glucose monitor (CGM) data.

Detailed description: Based on alerts from GluVue, care team members will proactively reach out to patients and their families for more frequent dose adjustments. We will assess if remote monitoring facilitates contact between the care team and patients and improves glycemic control.

Eligibility criteria: Inclusion Criteria:

* All individuals within one month of T1D diagnosis seen at the Stanford Children's Diabetes Clinic
* Individuals who plan to receive follow up care at the Stanford Children's Diabetes Clinic
* Individuals who agree to CGM data integration into the electronic medical record (EMR) for remote monitoring
* Age: birth to \< 21 years of age

Exclusion Criteria:

* Diabetes diagnosis other than T1D
* Diagnosis of diabetes \> 1 month prior to initial visit
* Individuals with the intention of obtaining diabetes care at another clinic
* Individuals who do not consent to CGM use, CGM data integration, or remote monitoring
* Individuals \> 21 years of age

Primary outcomes:
measure: Contacts with the care provider
timeFrame: 1 year
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: 1 year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Priya Prahalad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prahalad P, Ding VY, Zaharieva DP, Addala A, Johari R, Scheinker D, Desai M, Hood K, Maahs DM. Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Type 1 Diabetes: the Pilot 4T Study. J Clin Endocrinol Metab. 2022 Mar 24;107(4):998-1008. doi: 10.1210/clinem/dgab859.