louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04292977: Splanchnic and Systemic VLDL-TG and FFA Balance
Official title: Splanchnic and Systemic VLDL-TG and FFA Balance in Individuals With NAFL and NASH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NAFLD
NASH - Nonalcoholic Steatohepatitis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 17
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 8 obese subject men with NAFL (MR spectroskopi, fibro scanner) (BMI \> 28).

- 8 obese subject men with NASH (MR spectroskopi, fibro scanner) (BMI \> 28). age between 40-70 years.

Brief summary: To determine differences between NAFLD and NASH subjects with respect to hepatic FA metabolism (uptake, oxidation, and re-esterification) and hepatic VLDL-TG secretion and peripheral kinetics (oxidation and tissue storage). 8 non-diabetic upper-body obese subjects with NAFLD and 8 with NASH (biopsy proven) will be studied in the overnight fasted state. VLDL-TG stable isotope will be used in combination with hepatic vein catherization to directly measure splanchnic VLDL-TG uptake and secretion. FFA (palmitate) tracers as well as adipose tissue and skeletal muscle biopsies will be used to measure whole-body substrate turnover and flexibility as well as tissue specific substrate handling during fasting and hyperinsulinemic conditions.


Eligibility criteria: Inclusion Criteria:

* 8 obese subject men with NAFL (MR spectroskopi, fibro scanner) (BMI \> 28).
* 8 obese subject men with NASH (MR spectroskopi, fibro scanner) (BMI \> 28). age between 40-70 years. Written consent before the start of the study.

Exclusion Criteria:

* known current disease
* fixed medical drug consumption except antihypertensive drugs and statins. However, pause statins 3 weeks before the examination date Blood donation within the last 3 months prior to the study Participation in experiments involving radioactive isotopes within the last 3 months Alcohol abuse (over 21 items per week for men and 14 for women) Smoking Weight over 130 kg Cancer patients Large intake of medication

Primary outcomes:
measure: Splanchnic and systemic VLDL-TG and FFA balance in individuals with biopsy proven NAFL or NASH
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Skejby
country: Denmark
facility: Arhus University Hospital Department of Endocrinology and Internal Medicine Skejby, Aarhus N, Denmark, 8200
state: Aarhus N
Study officials:
References:
Clinical trial NCT02665377: Prevention of Akute Kidney Injury, Hearttransplant, ANP
Official title: Prevention of Akute Kidney Injury With Human Atrial Natriuretic Peptide in Patients Undergoing Heart Transplant.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Kidney Injury
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective, blinded, placebo-controlled trial. Patients: Adult patients (\>18 years of age) undergoing de novo Htx, with a preoperative GFR \> 30ml/min, not receiving an ABO-incompatible organ with an ischemia time of \> 6 hours. A donor age \> 70 years is an exclusion criteria.

Intervention: Infusion of h-ANP fore five days, starting at the induction of anesthesia.

Outcome: Kidney function, evaluated with serum creatinine day 1-7 and kidney clearance, 4-5 Days after Htx plus after 3 and 12 months.


Eligibility criteria: Inclusion Criteria:

* De novo Htx.
* Preoperative GFR \> 30ml/min/1,73m2.
* \>18 years old.
* Written consent.

Exclusion Criteria:

* Multi organ transplantation or previous heart transplant.
* ECMO
* Donor age \> 70 years.
* Dialysis.
* ABO-incompatible organ.
* Donor heart ischemia time \> 6 tim.
* Known kidney disease.
* Other planed study within 2 mounth.

Primary outcomes:
measure: GFR 4-5 days after Htx
timeFrame: 4-5 days
Secondary outcomes:
measure: GFR 1 year after Htx
timeFrame: 1 year
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska sjukhuset
Study officials:
affiliation: Sahlgrenska universitetssjukhuset
name: Sven-Erik Ricksten, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05947877: Non-Pharmacological Nursing Pain Management for Preterm Infants
Official title: Effectiveness of Interventional Non-Pharmacological Nursing Pain Management for Preterm Infants at Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Keywords: Non-pharmacological Pain Management Strategies
Preterm Infants
NICU
Lead sponsor: University of Baghdad
Sponsor class: OTHER
Collaborators: name: Numan Nafie Hameed
First posted: 2023-07-17
Enrollment: 105
Sex: ALL
Minimum age (years): 32
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized controlled trial will be conducted to examine the effect of non-pharmacological nursing pain management strategies in alleviating pain among preterm infants. The study includes a simple random sample of 105 preterm infants with CGA 32- \< 37 weeks were randomly assigned into five groups: routine care (n = 21), breast milk (n = 21), oral sucrose (n = 21), KMC (n = 21), nesting position (n = 21). PIPP-R will be used to subjectively assess the pain intensity after heel stick, and salivary cortisol measures will be used to objectively assess the pain intensity in NICU at Children Welfare Teaching Hospital/ Medical City Complex in Baghdad City.


Eligibility criteria: Inclusion Criteria:

* Preterm infants whose corrected gestational age from (32 - \<37) weeks of pregnancy,
* Preterm infants who do not experience any painful procedure for last 24 hours.
* Preterm infants who do not receive any sedation for last 24 hours, and clinically required heel stick.

Exclusion Criteria:

* Full-term infants whose gestational age (GA) is \>37 weeks
* Preterm infants who extremely preterm (\< 28 weeks); very preterm (28-\< 32 weeks)
* Preterm infants who are proven or suspected sepsis, major congenital malformations, heart defect, necrotizing enterocolitis (NEC), and neurodevelopmental disability.
* Preterm infants who receive respiratory support {Mechanical Ventilation, Continuous Positive Airway Pressure (CPAP), or high-flow support}
* Preterm infants who are indicated for surgery
* Preterm infants who are contraindicated to oral sucrose
* Twins
* Preterm infants who had a condition that might influence their physiological and responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs.

Primary outcomes:
measure: Premature Infant Pain Profile - Revised
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Nursing- The University of Baghdad
Study officials:
References:
Clinical trial NCT04864977: A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes
Official title: Novel Approach for Basal Insulin Titration: A Proof-of-Concept Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Type 2 Diabetes Treated With Insulin
Keywords: T2D
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate a novel approach for insulin glargine (LY2963016) titration for insulin-naïve adults with type 2 diabetes (T2D)

The study will last about 6 months.


Eligibility criteria: Inclusion Criteria:

* Adults with type 2 diabetes as diagnosed by endocrinologist
* No insulin over past 3 months
* Inadequate glycemic control with A1c ≥8.0% at or within 1 month prior to screening visit
* No history of diabetic ketoacidosis (DKA) or severe hypoglycemia leading to mental status change in the past 6 months
* Willingness and ability to follow the protocol including willingness to commence basal insulin, wear CGM, and communicate with healthcare provider.

Exclusion Criteria:

* Contraindication to use of insulin glargine (e.g., allergy)
* Impaired recognition of hypoglycemia by the participant (as judged by the investigator)

Primary outcomes:
measure: Percentage of Participants with Type 2 Diabetes Who Achieve Nadir Glucose in Range 70-125 milligram/deciliter (mg/dL)
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants with Hemoglobin A1c (HbA1c) at target (<7.0%)
timeFrame: Week 12
measure: Percentage of Participants with time in range (TIR) 70-180 mg/dl ≥70%
timeFrame: Week 12
measure: Percentage of Participants who successfully use Continuous Glucose Monitoring (CGM)
timeFrame: Week 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01387477: Lactate to Treat Hypoglycemia
Official title: Comparison of Two Strategies of Hypoglycemia Correction in ICU
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hypoglycemia
Keywords: hypoglycemia
lactate
glucose
ICU
Lead sponsor: Institut d'Anesthesiologie des Alpes Maritimes
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 0
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: Tight glucose control in intensive care has become a major concern, allowing a reduction in morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which can have severe consequences on the brain. The bispectral index (BIS) is derived from the EEG and measures of brain electrical activity noninvasively. It has already been shown that its value changes according to hypoglycemia and its correction. Furthermore, if the hormonal response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case in ICU patient. The usual treatment of hypoglycemia is based on parenteral infusion of glucose. Btu this can lead to a hyperglycemic rebound that can be deleterious. Lactate is a substrate for gluconeogenesis and an energy substrate during critical situations. It has been shown to improve neurological tests during hypoglycaemia and had cerebral protective properties after a severe head injury. The hypothesis of this study is that sodium lactate is superior than the 30% glucose to correct hypoglycemia in the ICU in terms of glycemic variation, brain function and hormonal response.


Eligibility criteria: Inclusion Criteria:

* hypoglycemia under 0.6 g/L

Exclusion Criteria:

* hepatic failure
* hyperlactatemia above 5 mmol/L

Primary outcomes:
measure: Area under the curve of the glycemia
timeFrame: 30 minutes
Secondary outcomes:
measure: Bispectral index variation
timeFrame: 60 minutes
measure: Maximum change in glycemia
timeFrame: 30 minutes
measure: Changes in growth hormone and cortisol
timeFrame: 180 minutes
measure: Need for glucose infusion for persistent hypoglycemia
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Nice
country: France
facility: Réanimation médico-chirurgicale
Study officials:
affiliation: Nice University Hospital
name: Jean-Christophe Orban, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05586477: Diphenhydramine and Sweating
Official title: Does Diphenhydramine Alter Thermoregulatory Responses During Exercise?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diphenhydramine Causing Adverse Effects in Therapeutic Use
Hyperthermia
Allergic Rhinitis
Sweating
Keywords: thermoregulation
diphenhydramine
anticholinergic
sweating
Lead sponsor: Lakehead University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In 2012, it was estimated that nearly 1 in 4 Canadians suffer from allergic rhinitis. To add, 78% of individuals working in predisposing environments are predicted to develop occupational rhinitis. Currently, the most popular treatment for rhinitis is antihistamine medication such as diphenhydramine, a first-generation antihistamine sold commercially as Benadryl®. Due it its anticholinergic effects, diphenhydramine has been suggested to impair the whole body sweating response during heat stress, potentially leaving consumers at an increased risk of heat-related illness. This randomized control trial approved by Health Canada will investigate whether ingesting extra strength diphenhydramine (50mg) will alter whole-body sweat losses during 60 minutes of exercise.


Eligibility criteria: Inclusion Criteria:

* Able to safely perform \~60 minutes of moderate intensity exercise
* No known hypersensitivity to diphenhydramine
* Not on any prescribed medication
* Body-mass index (BMI) less than 30

Exclusion Criteria:

* Outside 18 - 49 years of age
* Diagnosed with any cardiovascular, respiratory, neurological or metabolic disease
* History of any cardiovascular, respiratory, neurological or metabolic disease
* Unable to exercise for 60 minutes at moderate intensity, or have a musculoskeletal injury
* BMI \> or = 30

Primary outcomes:
measure: Whole body sweat loss
timeFrame: Measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days
Secondary outcomes:
measure: Change in rectal temperature
timeFrame: Measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Lakehead Unviersity
state: Ontario
Study officials:
affiliation: Lakehead University
name: Nicholas Ravanelli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00607477: Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension
Official title: A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Treatment Induced Hypertension
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.


Eligibility criteria: Inclusion Criteria:

* Ongoing treatment for malignancy by at the University of Chicago with any agent with recognized, specific inhibition of VEGF, VEGF-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. These agents include but are not limited to: bevacizumab (Avastin™), sorafenib (Nexavar™), sunitinib (Sutent™), axitinib (AG-013736), and AZD 2171.
* Treatment of hypertension with at least 2 or more anti-hypertensive medications with blood pressure remaining greater than 140/90 mmHg.
* Stable management of other toxicities from the cancer treatments
* Expected to continue current cancer treatments for at least 4 weeks
* 18 years and older
* Ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures.

Exclusion Criteria:

* Concurrent use of hematopoietic supportive treatment with erythropoietin or congeners.
* Current uncontrolled toxicities due to the cancer treatments.
* Patients having known contraindications to hydralazine or minoxidil therapy.
* Any readings of systolic blood pressure \>200 mmHg or diastolic blood pressure \>120 mmHg in the four (4) weeks prior to screening.
* Use of either minoxidil or hydralazine in the six (6) months prior to screening.

Primary outcomes:
measure: Magnitude of Change in Blood Pressure
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Michael Maitland, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05867277: Effect of Music on Nursing Students' Skills, Anxiety
Official title: The Effect of Music on Nursing Students' Skills, Anxiety, Self-Confidence Perception, Vital Sings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music
Keywords: Nursing student
intravenous catheter
anxiety
music
self-confidence
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded study with parallel groups.
Primary purpose: OTHER

Brief summary: Objectives: This study aimed to determine the effect of music on nursing students' skills, anxiety, self-confidence perception, and vital signs.

Detailed description: Design: Single-blinded study with parallel groups. Setting: Faculty of Nursing. Participants: Sixty first-year students who took the Nursing Fundamentals course were randomly assigned to the intervention (n = 30) and control (n = 30) groups.

Methods: Data were collected using the Student Information Form, Subjective Self-Confidence Assessment Tool, and State Anxiety Scale from April 6 to 11, 2022. The students in the intervention group listened to music for 15 min before and during the peripheral intravenous catheter placement skill practice, while no intervention was applied in the control group.

Eligibility criteria: Inclusion Criteria:

* Taking the Nursing Fundamentals Course for the first time
* Not placing an IV catheter before
* Volunteering to work

Exclusion Criteria:

* Being a healthy vocational high school graduate
* Being a foreign student

Primary outcomes:
measure: Anxiety evaluated using the State Anxiety Scale
timeFrame: It was applied 10 minutes after the intervention.
measure: The skill level of the students was evaluated using the "IV Catheter Insertion Skill Checklist"
timeFrame: It was applied 30 minutes after the intervention.
Secondary outcomes:
measure: Students' self-confidence perceptions were determined using a subjective assessment tool.
timeFrame: It was applied 10 minutes after the intervention.
measure: Blood pressure was evaluated with a sphygmomanometer.
timeFrame: It was measured 10 minutes after the intervention.
measure: Pulse was evaluated with a pulse oximeter device.
timeFrame: It was measured 10 minutes after the intervention.
measure: Respiration was evaluated by observation.
timeFrame: It was measured 10 minutes after the intervention.
measure: Oxygen saturation was evaluated with a pulse oximetry device.
timeFrame: It was measured 10 minutes after the intervention.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Turkey, Necmettin Erbakan University
Study officials:
affiliation: Necmettin Erbakan University
name: Serpil SU
role: STUDY_CHAIR
References:
Clinical trial NCT02480777: Expanded Access for Single Patient Treatment of Autologous Human Schwann Cells (ahSC) for Peripheral Nerve Repair
Official title: Expanded Access for Single Patient Treatment of Autologous Human Schwann Cells (ahSC) for Peripheral Nerve Repair
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Sciatic Nerve Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Miami Project to Cure Paralysis
First posted: 2015-06-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The primary purpose of this research study is to determine the safety of injecting ones own Schwann cells as a supplement along with nerve autograft (eg sural nerve) a few weeks after a severe injury to the sciatic nerve has occurred.

Detailed description: The secondary purpose of this research project is to evaluate whether transplanted Schwann cells can enhance recovery of sensory and motor function. Emergency expanded access for a single patient was granted, as the patient was an ideal candidate for sural nerve repair augmented by autologous Schwann cells which could be harvested either from a relatively small segment of sensory nerve or as in this case from local debridement of injured nerve at the epicenter of the nerve injury. The cells were expanded using cell culture techniques and placed along with the sural nerve grafts wrapped by an FDA approved collagen matrix (Duragen). This study is being conducted at the Jackson Memorial and the University of Miami health systems. As a research subject the patient will be in this study for a total of 5 years from the date receiving Schwann cell transplant augmentation of sural nerve autografts.

Eligibility criteria: - single patient with severe sciatic nerve injury enrolled under emergency request

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Allan Levi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: