louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01219608: Iranian Intensive Care Unit (ICU) Glutamine Study
Official title: Iranian Intensive Care Unit (ICU) Glutamine Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma Patients in ICU
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Isfahan University of Medical Sciences
First posted: 2010-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a double-blinded placebo-controlled block randomized study in intensive care patients comparing enteral glutamine supplementation to placebo. The hypothesis is an improvement of clinical and paraclinical outcomes. The primary endpoint is Infection Probability Score (IPS) and Systemic Inflammatory Response Syndrome (SIRS). Anthropometric measures and serum inflammatory mediators will be compared.


Eligibility criteria: Inclusion Criteria:

* Age 18-60
* No corticosteroids use
* No history of heart, liver and kidney diseases
* Nutrition through nasogastric or orogastric

Exclusion Criteria:

* Patients who will not tolerate enteral nutrition for more than 48 hours
* Patients who are NPO and nutritional support has not started
* Lactating and pregnant women
* Kidney failure during the study
* A history of glutamin supplement use before the study

Primary outcomes:
measure: Infection Probability Score
timeFrame: 10 days after intervention
measure: Systemic Inflammatory Response Syndrome
timeFrame: 10 days after intervention
Secondary outcomes:
measure: Prealbumin
timeFrame: 10 days after intervention
measure: CRP
timeFrame: 10 days after intervention
measure: Serum prealbumin
timeFrame: 10 days after the intervention
measure: Length of stay (LOS)
measure: Bed sores
timeFrame: 10 days after intervention
measure: Mechanical ventilation
timeFrame: 10 days after intervention
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-Zahra Hospital
Study officials:
References:
Clinical trial NCT06123208: Impact of Eating Beans on Metabolism
Official title: The Influence of the Resistant Starch and Protein Content of Pulses on Substrate Oxidation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Overweight
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2023-11-08
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this research is to test how eating a meal containing beans impacts how participants' bodies use food for energy.

Detailed description: The objective of this project is to test whether consuming a whole food that naturally contains resistant starch (RS), such as pulses, increases fat oxidation. The primary hypothesis is that consuming a RS-rich meal in which the RS is derived from a whole food (i.e., pinto beans, pinto bean flour) will increase postprandial fat oxidation to a greater extent than consuming a meal low in RS but containing the same amount of energy and macronutrient content.

Eligibility criteria: Inclusion Criteria:

* BMI \>18.5 or \<30 kg/m2
* Ability to understand and sign the consent form
* Ability of transportation (i.e., participants must be able to provide their own transportation to the Grand Forks Human Nutrition Research Center)
* Non-smoking or use of other tobacco products, including e-cigarettes
* Not taking steroid-based medications; not planning to or currently attempting to gain or lose weight
* All females of childbearing age must be on birth control for a minimum of 3 months prior to start of study

Exclusion Criteria:

* Inability or unwillingness to consume any food item in the test meals
* More than a 10% change in body weight within the past 2 months
* Participation in a weight loss diet/exercise program
* Current or planned pregnancy
* Lactation
* Uncontrolled hypertension (systolic \>160 mmHg or diastolic \>100 mmHg)
* Diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases
* Fasting glucose \> 100 mg/dL or non-fasting (1-2 hours after eating) \>140 mg/dL
* Using medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids, antidepressants)
* Non-English speaking

Primary outcomes:
measure: Acute effects of consuming processed pulse-based food products on substrate utilization
timeFrame: 5 hours after meal consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Shanon Casperson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00576108: A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Shingles
Herpes Zoster
Neuropathic Pain
Lead sponsor: Kalypsys, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects ages 18-85 years
* Previous diagnosis of Shingles (Herpes Zoster) with pain persisting for at least 3 months, but not longer than 5 years, after healing of rash
* Subject with intact skin in the targeted treatment area
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening, a negative urine human chorionic gonadotropin (hCG) test prior to randomization, and must use medically acceptable methods of birth control. All subjects must agree to take every precaution to ensure that pregnancy will not occur during the study.
* Subject must be willing and able to complete screening and study procedures as described int he protocol.
* Subject must voluntarily provide written Informed Consent prior to participation.

Exclusion Criteria:

* Subjects with known hypersensitivity to KD7040 or methylparaben, or previous exposure to KD7040.
* Subjects pregnant, nursing or planning to become pregnant.
* Subjects who are immunocompromised or have clinically significant hematological abnormalities.
* Subjects with system dermatological conditions (e.g., psoriasis, atopic dermatitis) or impaired wound healing.
* Subjects who have had local anesthetic nerve blocks within 48 hours of study entry.
* Subjects having other sever pain which may confound assessment of PHN.
* Subjects who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the Investigator(s) would compromise the subjects' participation in the study.

Primary outcomes:
measure: Worst daily pain
timeFrame: Once daily
Secondary outcomes:
measure: Average daily pain
timeFrame: Once daily
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: United Bioscience Corporation
state: Missouri
Study officials:
References:
Clinical trial NCT02922608: French Survey About Student's Sleep Perturbations Before Simulation Session.
Official title: French National Investigation About Student's Sleep Perturbations Before Simulation Session.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Anxiety
Keywords: Education, Medical
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 1150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents coming to simulation center for high fidelity simulation education program.

Brief summary: High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants.

The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session. The investigators would like to investigate with a survey how much participants had their sleep affected before the simulation session.

Detailed description: High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants.

The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session.

The investigators would like to investigate with a survey how much participants had their quantity and quality of sleep affected before the simulation session.

Eligibility criteria: Inclusion Criteria:

* french talking residents coming to high fidelity simulation

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: modification of the sleeping Leeds test
timeFrame: day 1
Secondary outcomes:
measure: incidence of sleep perturbations
timeFrame: day 1
measure: analysis of demographics and sleep perturbations
timeFrame: day 1
Other outcomes:
Locations:
city: Lyon
country: France
facility: CLESS
state: Rhône-Alpes
Study officials:
affiliation: Cless
name: jean-jacques lehot, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT00637208: Sclerotherapy of Internal Spermatic Veins in Patients With Varicocele and Localized Prostate Cancer
Official title: Selective Retrograde Venography and Sclerotherapy of Internal Spermatic Veins and Associated Venous Bypasses and Retro-Peritoneal Collateral in Patients With Bilateral Varicocele and Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
venography
male patients
Localized microscopic prostate cancer up to Gleason 6 (3+3)
PSA level <14
presence of varicocele
Lead sponsor: Maaynei Hayesha Medical Center
Sponsor class: OTHER
First posted: 2008-03-17
Enrollment: 10
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with varicocele in whon early prostate cancer will be found will undergo venographic embolization of both spermatic veins. The study hypothesis is that this procedure will induce a gradual regression of the prostate volume that may decrease prostate cancer cells. Close follow-up will ensure that necessary therapy will be provided if needed according to clinical criteria. Results in terms of prostate size PSA level and tumor size will be recorded.


Eligibility criteria: Inclusion Criteria:

* Males age 45-75
* Prostate cancer
* Presence of varicocele
* No contraindication for venography

Exclusion Criteria:

* Diseases or medications which prevent interventional vascular procedures

Primary outcomes:
measure: Safety performance of the procedure. The change in tumor size and prostate cancer cells as evaluated by trans-rectal ultrasound and prostate biopsy
timeFrame: one year
Secondary outcomes:
measure: The change in size of the prostate as evaluated by ultrasound Change in PSA value. Reduction of above 20% in nocturia
timeFrame: one year
Other outcomes:
Locations:
city: Bnei Brak
country: Israel
facility: Maaynei Hayesha Medical Center
Study officials:
References:
Clinical trial NCT01889108: Feasibility Study of SPEEDI
Official title: Feasibility Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) for Infants Born Preterm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Premature
Keywords: Premature
Development
Motor
Cognitive
Parent
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 10
Sex: ALL
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed feasibility study will evaluate the investigators ability to conduct a clinical trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature. Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from current early intervention practices in 2 important ways. First it bridges the traditional gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and intensive support for developmental activities when parents are establishing care giving routines. Second, in contrast to wide-ranging intervention provided by current early intervention models, SPEEDI uses an action perception model to target specific behaviors which lead to improved early motor abilities and provide a foundation for learning.\[6\] The purpose of this feasibility study is to extend the investigators preliminary data and evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy of SPEEDI.


Eligibility criteria: Inclusion Criteria:

* infants born preterm at 34 weeks Post Menstrual Age (PMA) or less
* medically stable,
* off ventilator support,
* demonstrate thermoregulation in an open crib by 35 weeks of PMA,
* live within 60 minutes of the hospital, and
* have one parent who is English speaking and willing to participate in the study intervention and assessments

Exclusion Criteria:

* genetic syndrome or
* musculoskeletal deformity

Primary outcomes:
measure: Test of Infant Motor Performance
timeFrame: Change from baseline to the end of intervention at 3 months of adjusted age
measure: Problem Solving Behaviors
timeFrame: end of intervention at 3 months of adjusted age
measure: Reaching
timeFrame: end of intervention at 3 months of adjusted age
Secondary outcomes:
measure: Parent Child Interactions
timeFrame: End of intervention at 3 months of adjusted age
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
References:
Clinical trial NCT02960308: Whole-Neck Computed Tomography Perfusion Scan in Imaging Patients With Head and Neck Tumors
Official title: A Pilot Study of Whole-Neck CT Perfusion With the Toshiba Aquilion ONE ViSION-320 Detector Row CT Scanner for Use in Head &Amp; Neck Tumor Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Neoplasm
Malignant Head and Neck Neoplasm
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-11-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seen at USC/Norris Comprehensive Cancer Center who have confirmed or suspected head and neck tumor (benign or malignant) who are scheduled for contrast CT (standard of care) will be recruited for the study.

Brief summary: This pilot clinical trial studies how well whole-neck computed tomography perfusion scans work in imaging patients with head and neck tumors. Diagnostic imaging procedures, such as whole-neck computed tomography perfusions scans, may provide more information about the blood supply to head and neck tumors which may help doctors plan better treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the difference in whole-neck computed tomography perfusion (WNCTP) parameters (blood volume \[BV\], blood flow \[BF\], capillary permeability \[CP\] and mean transit time \[MTT\]) between head and neck tumor masses (benign or malignant) and adjacent normal skeletal muscle within the same patient.

II. To assess whether the difference in WNCTP parameters between tumor masses and adjacent normal skeletal muscle is different between patients with benign tumor versus (vs.) malignant tumor.

III. To assess the correlation in WNCTP parameters between tumor masses and adjacent normal skeletal muscle.

IV. Determine if more suspicious cervical lymph nodes will be seen using the whole-neck coverage employed in WNCTP compared to the limited coverage of traditional neck CTP.

OUTLINE:

Patients undergo WNCTP scan over 2-3 minutes during standard of care computed tomography (CT).

After completion of study, patients are followed up within 2 days.

Eligibility criteria: Inclusion Criteria:

* Confirmed or suspected head and neck tumor (benign or malignant)
* Scheduled for contrast CT (standard of care)
* No known allergies to contrast material

Exclusion Criteria:

* Known allergies to contrast material
* Pregnant or nursing

Primary outcomes:
measure: Number and site of each suspicious lymph node assessed by WNCTP
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Mark Shiroishi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04131608: Effect of Iron Deficiency Anemia on HBA1C in Patients With Diabetic Foot Ulcer Grade (1and2)
Official title: Effect of Iron Deficiency Anemia on HBA1C in Patients With Diabetic Foot Ulcer Grade (1and2)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron Deficiency Anemia
HBA1C
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients with diabetic foot ulcer grade one and two with or without iron deficiency anemia

Brief summary: Diabetic foot ulcer is the commonest cause of severe limb ischemia in diabetes mellitus And development of anemia is an additional burden to the microvascular complications of diabetes

Detailed description: HBA1C is the predominant Hemoglobin found in HBA1 fraction and it constitutes 5% of total Hemoglobin in normal adults and up to 15%in patients with diabetes mellitus HBA1C is used to diagnose diabetes and to identify individuals that are at high risk for developing diabetes Iron deficiency anemia is one of the most prevalent form of malnutrition affect 1,62 billion people whish correspond to 24,8%of the world population Ferritin is the storage form of iron so it is found to be test for distinguishing those with iron deficiency anemia from those who are not iron deficient

Eligibility criteria: Inclusion Criteria:

* all diabetic patients with diabetic foot ulcer grade one and two above 18 year

Exclusion Criteria:

1. patients with anemia other than iron deficiency anemia
2. Patients on anticoagulants
3. patients with blood disease 4-patients below 18

Primary outcomes:
measure: Iron deficiency detected by Hemoglobin level in g/dl HBA1C level in diabetic patients
timeFrame: Base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kim S, Min WK, Chun S, Lee W, Park HI. Glycated albumin may be a possible alternative to hemoglobin A1c in diabetic patients with anemia. Clin Chem Lab Med. 2011 Oct;49(10):1743-7. doi: 10.1515/CCLM.2011.646. Epub 2011 Jun 17.
citation: American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2010 Jan;33 Suppl 1(Suppl 1):S62-9. doi: 10.2337/dc10-S062. No abstract available.
citation: Kim C, Bullard KM, Herman WH, Beckles GL. Association between iron deficiency and A1C Levels among adults without diabetes in the National Health and Nutrition Examination Survey, 1999-2006. Diabetes Care. 2010 Apr;33(4):780-5. doi: 10.2337/dc09-0836. Epub 2010 Jan 12.
citation: Wolffenbuttel BH, Herman WH, Gross JL, Dharmalingam M, Jiang HH, Hardin DS. Ethnic differences in glycemic markers in patients with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):2931-6. doi: 10.2337/dc12-2711. Epub 2013 Jun 11.
citation: American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014 Jan;37 Suppl 1:S81-90. doi: 10.2337/dc14-S081. No abstract available.
Clinical trial NCT03897608: Quality of Life in Patients With HCV Related Liver Cirrhosis Before and After Direct Acting Antiviral Drugs
Official title: Quality of Life in Patients With HCV Related Liver Cirrhosis Before and After Direct Acting Antiviral Drugs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HCV Related Liver Cirrhosis Direct Acting Antiviral Drugs
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hepatitis C related liver cirrhosis being treatedusing the Egyptian National Guidelines will be enrolled. According to the most updated treatment protocol, patients undergo therapy for a relatively short period (3 to6 months).

Brief summary: To evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection

Detailed description: Hepatitis C has been associated with substantial resource utilization as a result of its effect on the liver as well as other organ systems (the extrahepatic manifestations of HCV). It has been widely reported to have a profound negative impact on patient's health-related quality of life (HRQL).

The reduction of HRQL is probably also due to physical and psychiatric symptoms as a direct consequence of this chronic infection and its sequelae (such as cirrhosis). The chronic inflammation is believed to signal the brain and to give rise to neurovegetative symptoms (e.g. malaise and fatigue) and to amongst others depression and concentration difficulties. Possibly, also the brain itself is infected by HCV . The Egyptian government introduced Sofosbuvir as the first DAAs into Egypt through the government funded National Treatment Program. These agents are highly efficacious with significantly fewer side effects .

To date, there is only one study reported about how Egyptian HCV patients receiving the new DAAs perceive their HRQL. This study is first one to be done in Upper Egypt to assess health-related quality of life of HCV patients receiving direct acting antivirals (DAAs) therapy prior and at the end of therapy

Eligibility criteria: Inclusion Criteria:

* Patients with hepatitis C related liver cirrhosis (diagnosed clinically laboratory and by imaging).
* Age 18 years or older
* Eligible for starting DAAs therapy according to Egyptian National Guidelines will be enrolled.
* Follow up of those patients during and after DAAs therapy (clinically ,laboratory,imaging and with a questionnaire ) to determine HRQL.

Exclusion Criteria:

* Any patient with liver cirrhosis secondary to causes other than chronic HCV infection e. g. auto immune liver disease, PBC
* Coinfection with other viruses as HBV, HIV.
* Had significant psychiatric illnesses (diagnosed by psychiatrist)

Primary outcomes:
measure: Quality of Life in patients with HCV related liver cirrhosis before and after Direct Acting Antiviral Drugs
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: