louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00428701: An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium
Official title: An Open-Label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium I.V. (Esomeprazole Sodium) 40mg BID for up to 72 Hours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Ulcer
Keywords: stress ulcer
critically ill
gastric acid
gastric aspirates
esomeprazole
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to see if Nexium I.V. can reduce and control stomach acid in mechanically ventilated, critically ill patients in an Intensive Care Unit setting.


Eligibility criteria: Inclusion Criteria:

* Critically ill male or female subjects 18 years or older who have a baseline gastric aspirate pH less then or equal to 4
* Subjects admitted to an ICU requiring mechanically ventilated
* Subjects will have at least one additional stress ulcer risk factor

Exclusion Criteria:

* Anticipated use of pre-pyloric enteral feeding after screening until the end of study
* Physician estimated survival of less then 96 hours
* Anticipation of major surgery within 96 hours of study enrollment

Primary outcomes:
measure: The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
Secondary outcomes:
measure: The secondary objective is to assess time to stable pH greater then or equal to 4 from start of drug
Other outcomes:
Locations:
city: Newark
country: United States
facility: Research SIte
state: Delaware
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
Study officials:
affiliation: AstraZeneca
name: Mark Sostek, MD
role: STUDY_DIRECTOR
References:
citation: Metz DC, Fulda GJ, Olsen KM, Monyak JT, Simonson SG, Sostek MB. Intravenous esomeprazole pharmacodynamics in critically ill patients. Curr Med Res Opin. 2010 May;26(5):1141-8. doi: 10.1185/03007991003694308.
Clinical trial NCT02209701: Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors
Official title: A Phase I Intensive Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors Who Receive Radiation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Head and Neck Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin and major metabolites in head and neck cancer and other cancer patients with solid tumors who receive radiation therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven advanced head and neck cancer or other solid tumors undergoing radiation therapy
* Patients with prior chemotherapy will be considered if chemotherapy occurred more than 30 days prior to this study
* Patients must be receiving concomitant radiotherapy (RT)
* Performance status of ≥ 70% on the Karnofsky performance scale (KPS)
* Must be ≥ 18 years of age
* Expected survival of at least three months
* Written informed consent

Exclusion Criteria:

* Patients who meet any of the following clinical laboratory criteria:

  * Granulocyte count of \< 2000/mm\*\*3
  * Platelets \< 75,000/mm\*\*3
  * Serum creatinine \> 1.5 times the upper limit of normal
  * Bilirubin \> 1.5 times the upper limit of normal
  * Prothrombin time and partial thromboplastin time \> 1.5 times the upper limit of normal
* Women who are pregnant
* Men and women of child-bearing potential who are unwilling to utilize a medically acceptable method of contraception
* Patients who have any known bleeding disorder at the discretion of the investigator
* Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependent chronic obstructive pulmonary disease, or unstable liver or renal disease
* Treatment with granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor or Interleukin-1l within 30 days prior to the start of RT
* Patients who have had prior exposure to mitomycin C or porfiromycin

Primary outcomes:
measure: Assessment of serum concentrations of the analyte
timeFrame: up to 6 hours after drug infusion
measure: Amount of analyte excreted in urine
timeFrame: 0-3 and 3-6 hours after infustion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04140201: Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
Official title: Evaluation of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Retinopathy
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator study evaluate the effect of different lipid lowering agents on the progression of diabetic retinopathy and other reduction of cardiovascular risk of diabetic patients

Detailed description: The investigator study compare the effect of lipid lowering agent on the enhancement of visual acuity and on reduction of macular edema in patients with diabetic retinopathy and also compare their effect on reduction of cardiovascular risk on diabetic patients via assessment of ASCVD risk score

Eligibility criteria: Inclusion Criteria:

* type 2diabetes
* Non proliferative diabetic retinopathy

Exclusion Criteria:

* Uncontrolled glycemic level
* proliferative diabetic retinopathy

Primary outcomes:
measure: The 80 participants will be evaluated through reduction of macular edema
timeFrame: 18 weeks
Secondary outcomes:
measure: The 80 participants will be evaluated through reduction of cardiovascular risk
timeFrame: 18 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02888301: 18F-Clofarabine PET/CT in Imaging Cancer Patients Before and After Interventions
Official title: The Biodistribution of [18F]-Clofarabine in Cancer Patients Before and After Interventions That Increase the Activity of Deoxycytidine Kinase
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malignant Neoplasm
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 12
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: Adult cancer patients under treatment using immune system activating interventions.

Brief summary: This clinical trial studies 18F-clofarabine positron emission tomography (PET)/computed tomography (CT) in imaging patients with cancer before and after treatment with a therapy that activates the patient's immune system (immunotherapy). PET/CT scans give detailed pictures of areas inside the body. 18F-clofarabine is a drug that contains a radioactive substance that is taken up by cells expressing deoxycytidine kinase (dCK), which is highly expressed in activated immune cells, making them light up during PET/CT scans. Doctors also want to know how 18F-clofarabine is distributed throughout the body before and after treatment with immunotherapies.

Detailed description: PRIMARY OBJECTIVES:

I. To determine whether positron emission tomography (PET) using the new imaging agent 18F-clofarabine can be used for imaging cancer, and whether interventions that activate the immune system can change the biodistribution of 18F-clofarabine.

OUTLINE:

Patients receive 18F-clofarabine intravenously (IV) and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy.

Eligibility criteria: Inclusion Criteria:

* Must be able to tolerate PET/CT (i.e. not claustrophobic and able to remain supine)
* No restrictions based on gender or racial/ethnic background

Exclusion Criteria:

* Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge

Primary outcomes:
measure: 18F-clofarabine concentration in cancer tissue
timeFrame: Up to 4 weeks
measure: Change in 18F-clofarabine biodistribution
timeFrame: Baseline to up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Martin Allen-Auerbach
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05398601: Periosteal Electrical Dry Needling in Knee Osteoarthritis
Official title: Effects Of Periosteal Electrical Dry Needling In Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Dry needling
Acupuncture
Mobilization with movement
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 26
Sex: ALL
Minimum age (years): 41
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of periosteal electrical dry needling as an adjuvant to MWM in knee osteoarthritis for pain management, for improvement in functional activities and for ROM (Range Of Motion)

Detailed description: Periosteal stimulation therapy (PST) or periosteal electroacupuncture applies direct electrical stimulation of the periosteum and its associated nerves using parsimoniously applied acupuncture needles over bony prominences. It is an aggressive local treatment for deep pain problems such as OA (osteoarthritis ) .

Mobilization with movement (MWM) is a manual therapy technique that is used most frequently for the management of musculoskeletal conditions. In this technique, the physiological movement is performed in a pain-free manner with accessory glides being applied in the direction towards the opposite of the previously painful movement to have the greatest improvement MWMs has shown promising various therapeutic benefits such as reduction of pain and improved range of motion. Previous evidence has shown the effectiveness of MWM on pain reduction and functional improvement in patients with knee OA.

The rationale for the use of PST in comparison with MWM techniques is to determine the effectiveness of periosteal electrical dry needling for the common use intervention for knee osteoarthritis.

Eligibility criteria: Inclusion Criteria:

1. Age group \>40,
2. Patient who met American college of Rheumatology criteria of Osteoarthritis,
3. Chronic knee pain \> 3 months,
4. Morning stiffness \<30 mins,
5. Crepitation
6. Bony tenderness

Exclusion Criteria:

1. Diagnosed Meniscal injury or Ligamentous injury,
2. History of Intraarticular injection in last 3 months,
3. generalized low back related leg pain,
4. Patients with fear of needles,
5. Patients administered with corticosteroids or receiving any other invasive treatment such as PRP, Stem cell therapy, Ozone therapy
6. History of any surgery of lower extremity in last 6 months
7. Malignancy

Primary outcomes:
measure: WOMAC scale for osteoarthritis
timeFrame: 4 weeks
Secondary outcomes:
measure: NPRS
timeFrame: 4 weeks
measure: 6 min walk test
timeFrame: 4 weeks
measure: Stair climb test
timeFrame: 4 week
measure: Range of Motion
timeFrame: 4 week
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Athlean Physical Therapy Clinic
Study officials:
affiliation: RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
name: KINZA ANWAR, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04727801: A Clinical Data Collection Study of Verily Patch
Official title: A Clinical Data Collection Study of Verily Patch
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Febrile
Afebrile
Lead sponsor: Verily Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2021-01-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 participants (50 febrile and 50 afebrile) will be enrolled at one investigational site. Febrile is defined as having sublingual temperatures of 37.50C or above. Participants that exhibit COVID-19 symptoms and/or COVID-19 diagnosis may be included in the study.

Brief summary: This is a single center, prospective, non-randomized prospective observational data collection study of the Verily Patch. The Verily Patch is an investigational wearable, continuous temperature sensor which will be evaluated against reference oral and axillary temperature measurements to support development activities for the Verily Patch.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Able to read and speak English
* Able to read and understand the Informed Consent Form
* Willing to wear Verily Patch in the axillary region
* Willing to comply with repeated self-measurement of oral and axillary temperatures and willing to record temperature readings
* Have a working smartphone device and willing to use it for study activities
* Willing to install study apps on their personal smartphone
* Willing to comply with all study-related procedures

Exclusion Criteria:

* Pregnant or breastfeeding during study participation
* Have known allergies to medical grade adhesives
* Have known cutaneous hypersensitivity
* Have infection in both axilla
* Have open injury or rash where the study device will be worn
* Have a cardiac pacemaker or other implanted electronic medical device(s)
* Have any additional condition or situation that, in the opinion of the investigator, makes the subject inappropriate for participation in the study

Primary outcomes:
measure: Data collection to support development activities for Verily Patch
timeFrame: Up to 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Verily Life Sciences
name: William Marks, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00842101: Compartmental Overpressures Associated to Reamed Intramedullary Nails
Official title: Effect of Reamed Intramedullary Nails in Tibial Fractures as a Factor of Rising Intracompartmental Pressures: A Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibial Fractures
Keywords: Intramedullary nails
Compartmental syndrome
Fractures
Lead sponsor: University of Andorra
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 80
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: Patients with tibial shaft fractures

Brief summary: The purpose of this study is to determine the effect of reamed intramedullary nails in tibial shaft fractures (as a standard treatment), in raising intracompartmental pressures and therefore determine if they are a risk factor for compartmental syndrome.

Detailed description: Compartmental overpressure is a serious problem in relation to the treatment of tibial shaft fractures. When reamed intramedullary nails are used, the risk of suffering a compartmental syndrome must be in mind of surgeons. Diagnostic of compartmental syndrome could be difficult just after the surgical intervention, because the patient is under conditions of regional anesthesia or opioids and analgesics, which could mask the symptomatology. In fact, when there is a great suspicion of this syndrome, we recommend measuring compartmental pressures; therefore, physicians might apply the term delta-P value, which is the result of the mean arterial pressure minus compartmental pressure. If this one is less than 30 mm Hg, a fasciotomy should be performed even when the clinical diagnostic is not clear.

Eligibility criteria: Inclusion Criteria:

* Tibial shaft fractures treated with intramedullary reamed nails

Exclusion Criteria:

* Tibial fractures treated with other types of fixation or nails not reamed.

Primary outcomes:
measure: intracompartmental pressures
timeFrame: 0-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Escaldes
country: Andorra
facility: Orthopaedic and Trauma Unit. Nostra Senyora de Meritxell Hospital
Study officials:
affiliation: Orthopaedic and Trauma Unit. Andorra´s Hospital
name: JOSE I TORRERO, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06281301: Improving Patient Understanding of Macrosomia
Official title: Improving Patient Understanding of Macrosomia: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macrosomia, Fetal
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 222
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of a graphic based education tool on patient knowledge of macrosomia through the use of a survey and to evaluate knowledge at 1-2 weeks after initial review of the education tool.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* greater than or equal to 36 weeks gestation.

Exclusion Criteria:

* unable to provide informed consent

Primary outcomes:
measure: Number of participants that showed Macrosomia knowledge as assessed by the score on a survey
timeFrame: immediately after intervention (about 5 minutes after intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Kristen Cagino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03768401: Accessible Mobile Health and Wellness
Official title: Accessible Mobile Health and Wellness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Physical Disability
Neurologic Dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Southeastern Minnesota Center for Independent Living
First posted: 2018-12-07
Enrollment: 2
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Can community outreach education help develop self-sustaining wellness and exercise programs, and will associated wellness clinics help persons with a neurological physical disability achieve better well-being?


Eligibility criteria: Inclusion Criteria:

* \[for community participants/caregivers/family members\] Ability to demonstrate clear communication and understanding of English.
* \[for participants with neurological physical conditions\] Neurological physical conditions including cerebral palsy, spinal cord injury, stroke, multiple sclerosis, or similar diagnoses
* \[for educational seminars\] \> 6 years of age.
* \[for wellness/exercise clinic\] 18 65 years of age
* \[for wellness/exercise clinic; participants with neurological physical conditions\] Clearance by primary care or treating physician

Exclusion Criteria:

* \[for participants with neurological physical conditions\] Unstable fractures
* \[for participants with neurological physical conditions\] Uncontrolled hypertension (combined systolic/diastolic \> 140/90 mmHg)
* \[for participants with neurological physical conditions\] Enrollment of individual deemed by study staff to be unsafe

Primary outcomes:
measure: Incidence of new self-sustaining wellness and exercise programs
timeFrame: 3 months post end of wellness clinics
Secondary outcomes:
measure: Efficacy of seminars for individuals with a neurological physical disability
timeFrame: 3 months post end of wellness clinics
measure: Efficacy of seminars for caregivers and clinic staff of patients with neurological physical disabilities
timeFrame: 3 months post end of wellness clinics
measure: Efficacy of wellness clinics
timeFrame: 3 months post end of wellness clinics
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kristin D Zhao
role: PRINCIPAL_INVESTIGATOR
References: