louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00738478: Quality of Life After Routine Nasogastric Decompression After Distal Gastrectomy for Gastric Cancer Patients
Official title: Phase III Study for the Significance of Nasogastric Decompression Tube After Curative Distal Gastrectomy for Gastric Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: distal gastrectomy
quality of life
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate whether distal gastrectomy without post-operative nasogastric decompression tube is better in terms of quality of life.

Detailed description: Nasogastric decompression tube is an intra-operative routine in most of the time to facilitate exposure of operative field during elective distal gastrectomy, however, whether it should be retained post-operatively is controversial. Nasogastric decompression tube helps to drain the gastric remnant in case there is edema around the gastrojejunostomy, ileus and delayed gastric emptying, which can theoretically relieve nausea and abdominal distension. However, nasogastric intubation could cause patients discomfort; also it has been shown that it would cause gastroesophageal reflux which may be associated with pulmonary complication.

Eligibility criteria: Inclusion Criteria:

* on the basis of whether distal gastrectomy was anticipated at WMUH for gastric cancer.

Exclusion Criteria:

* patients who were diagnosed inadequacy for this study by a physician.
* patients without an informed consent.

Primary outcomes:
measure: Quality of life
timeFrame: seven days after operation
Secondary outcomes:
measure: complication, hematological data,
timeFrame: the time of discharge
Other outcomes:
Locations:
city: Wakayama
country: Japan
facility: Second Department of Surgery, Wakayama Medical University
Study officials:
affiliation: Wakayama Medical University
name: Mikihito Nakamori, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01671878: Glucose and Insulin Responses to Test Foods
Official title: Characterization of the Postprandial Glucose and Insulin Responses to Test Foods in Lean and Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Response
Insulin Response
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Glycemic Index Laboratories, Inc
First posted: 2012-08-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: In this study, postprandial glucose and insulin responses of different foods will be measured in individuals with varying body weight.


Eligibility criteria: Inclusion Criteria:

* Participants will be non-smoking males or non-pregnant females aged 20-45y, with normal glycemia and in good health. A total of 12 participants will be included, where approximately half will be male \& half female, and half normal weight (BMI \> 19.0 and \< 25.0) and half overweight but not obese (BMI \> 25.0 and \< 30). Thus, no fewer than 5 male, 5 female, 5 normal weight and 5 overweight but not obese subjects will be included. Additional inclusion criteria will include:
* Absence of diabetes, impaired glucose tolerance and impaired fasting glucose, defined as having a fasting plasma glucose \< 5.6 mmol/L (100 mg/dL) AND plasma glucose levels \< 7.8 mmol/L (140 mg/dL) 2h after consumption of a 50 g glucose drink (OGTT will be administered during the screening visit)
* Systolic blood pressure 100-150 mmHg inclusive
* Diastolic blood pressure 60-90 mmHg inclusive
* Resting heart rate 50-90 beats/min inclusive after 3 minute rest
* Able to refrain from eating legumes and drinking alcohol the day before each test session
* Fasting triglycerides \< 2.0 mmol/L (178 mg/dL)
* Fasting HDL cholesterol \> 0.9 mmol/L (35 mg/dL) for males and \> 1.1mmol/L (42 mg/dL) for females
* Fasting LDL cholesterol \< 5.0 mmol/L (193 mg/dL)
* AST and ALT \< 120% of upper limit of normal (ULN)
* hsCRP \< 10 mg/L
* Urea and creatinine \< 150% ULN

Exclusion Criteria:

* failure to meet any one of the inclusion criteria
* age less than 18 or over 45 years
* known history or AIDS, hepatitis, diabetes or a heart condition
* participants using medications or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results
* participants who cannot or will not comply with the experimental procedures or do not follow GI Labs safety guidelines.
* Food allergies of any kind
* General anaesthesia in the month prior to inclusion.
* Smokers

Primary outcomes:
measure: Postprandial Glucose Response
timeFrame: 3 hours
Secondary outcomes:
measure: Postprandial Insulin Response
timeFrame: 3 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories
state: Ontario
Study officials:
affiliation: Glycemic Index Laboratories, Inc
name: Thomas Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06771778: Advancing the Role of the Neonatal Registered Dietitian Nutritionist
Official title: Elevating the Neonatal Dietitian for the Future: Insights From the Experts Themselves
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opinions of the Neonatal Registered Dietitian
Keywords: Neonatal Intensive Care Unit
Neonatal Dietitian Nutritionist
Neonatal Nutrition
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: The Rickard Foundation, Inc.
First posted: 2025-01-13
Enrollment: 253
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current and former Neonatal Registered Dietitian.

Brief summary: This observational study aims to identify the needs, engagement levels, and expertise of NICU RDNs and provide insights into their job satisfaction and career longevity.

This cross-sectional examination was conducted in March - April 2024 using a national, online, IRB-approved survey sent to established Neonatal and Pediatric Dietitian practice groups. A Qualtrics link was provided for current and former NICU RDNs to complete a 10-minute online survey.


Eligibility criteria: Inclusion Criteria: Current and former Neonatal Registered Dietitian(s)

-

Exclusion Criteria:

Practice outside of the USA and Canada.

Primary outcomes:
measure: Exploratory Neonatal Registered Dietitian Opinions
timeFrame: Time Frame: March 28 - April 2, 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Alayne M Gatto, M.S., R.D.N.
role: STUDY_CHAIR
References:
Clinical trial NCT05027178: Stroke Patients Receiving Chiropractic Care Post-rehabilitation
Official title: Phenotypic Comparison of Ischemic and Hemorrhagic Stroke Patients Receiving Chiropractic Care Post-rehabilitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Life University Center for Chiropractic Research is conducting a research study to better understand how 12-weeks of chiropractic care differentially affects the post-rehabilitation brain electrical patterns and body movement patterns of individuals who have experienced hemorrhagic versus ischemic stroke The study will involve visits to the Life University Center for Chiropractic Research (CCR) in midtown Atlanta. During the 12 weeks of focused care, chiropractic visits could be several times a week depending on the care plan. In addition to the chiropractic care, individuals will receive a physical examination and three follow-up assessments. The assessments in the CCR will include a non-invasive evaluation of the brain wave patterns using electroencephalography (EEG), completion of a few surveys, a balance assessment and a movement assessment. Qualified individuals will receive study treatment and care at no cost.


Eligibility criteria: Inclusion Criteria:

* Post stroke rehabilitation

Exclusion Criteria:

* Not experienced sub-arachnoid bleeding within the last 4 weeks, fractures or trauma to the skull, pregnancy, or progressive RA.

Primary outcomes:
measure: Stroke Impact Scale Survey
timeFrame: Baseline
measure: Stroke Impact Scale Survey
timeFrame: 4 weeks
measure: Stroke Impact Scale Survey
timeFrame: 8 weeks
measure: Stroke Impact Scale Survey
timeFrame: 12 weeks
measure: Resting State Electroencephalography
timeFrame: Baseline
measure: Resting State Electroencephalography
timeFrame: 4 weeks
measure: Resting State Electroencephalography
timeFrame: 8 weeks
measure: Resting State Electroencephalography
timeFrame: 12 weeks
measure: Kinematic Assessment of Performance on finger to nose test
timeFrame: Baseline
measure: Kinematic Assessment of Performance on finger to nose test
timeFrame: 4 weeks
measure: Kinematic Assessment of Performance on finger to nose test
timeFrame: 8 weeks
measure: Kinematic Assessment of Performance on finger to nose test
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Life University Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life Univeristy
name: Stephanie Sullivan, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05250778: Nudges on Hospitalist Behavior and Patient Satisfaction
Official title: Room Design Nudge on Hospitalist Bedside Etiquette and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Etiquette, Medical
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Physician behavior plays an important role on patient perception of their care team and on patient satisfaction. Though studies have attempted to impact how physicians interact with their patients through various initiatives, the effect of more subtle nudges on physician behavior have not been studies. As such, the investigators propose a randomized controlled deception trial to evaluate the impact of nudges on hospitalist behavior and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Hospitalist Physicians at Parkland Memorial Hospital who are willing to participate

Exclusion Criteria:

* None

Primary outcomes:
measure: Physician Sitting Rate
timeFrame: During the Observed Physician Encounter
Secondary outcomes:
measure: TAISCH: Tool to Assess Inpatient Satisfaction with Care from Hospitalists
timeFrame: Immediately Following Observed Physician Encounter
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
Study officials:
References:
Clinical trial NCT01904578: The Efficacy of Acupressure on Sleep Quality in Menopausal Women
Official title: The Effect of Acupressure on Sleep Quality in Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Poor Quality Sleep
Keywords: Menopause
Sleep quality
Acupressure
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-07-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 41
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sleep disorder is a common problem in menopausal women and the decrease in the sleep leads to poor daily activity. Traditional Chinese acupressure is a noninvasive, effective and safe technique that can be easily taught to menopausal women so that they apply it as a self-care method and a manager of sleep disruption. The purpose of the present study was to evaluate the effectiveness of acupressure on sleep quality of postmenopausal women.This double blind randomized clinical trial was performed on 120 qualified menopausal women at the age of 41-65 years; and sleep quality was measured with Pittsburgh Sleep Quality Index (PSQI ).Participants were randomly assigned to an acupressure group, a sham acupressure group and a control group by two time randomized method (systematic and simple randomized). These interventions were carried out for 4 consecutive weeks. Participants in acupressure group and sham acupressure group learned to carry out acupressure technique as a self care at home with the simultaneous massage techniques that were to be performed 2 hours before sleep, whereas only conversation was used in the control group. The statistical software package for social science (SPSS) Version 17 was used for data analysis.


Eligibility criteria: Inclusion Criteria:

* spending at least 12 months after amenorrhea or follicle stimulating hormone
* (FSH) Serum level ≥ 40,
* healthy of the pressure points,
* having a full consciousness
* having an acceptable ability of listening
* speaking to receive training
* doing the self- care techniques at home,
* no mental and physical disorders,
* getting a score higher than 5 from the Pittsburgh Sleep Quality Index (PSQI)
* able to sit for about 30 minutes.

Exclusion Criteria:

* having specific eating diets,
* addicted to narcotic drugs,
* using the drugs causing sleep disorders,
* suffering from special disease,
* taking hormonal drugs during 3 last months,
* using herbal medicine to improve the menopausal symptoms,
* BMI higher than 30,
* having the moderate and severe depression based on Beck Depression Inventory,
* feeling of severe tiredness/ fatigue and anxiety,
* having circular job specially night job
* lack of cooperation with researchers.

Primary outcomes:
measure: treatment of quality of sleep
timeFrame: 4 consecutive weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05590078: Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery
Official title: Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Virtual reality
preoperative anxiety
anxiety
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 106
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: This study evaluate the interest of Virtual Reality to reduce the preoperative anxiety in patients who undergo to ambulatory surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.


Eligibility criteria: Inclusion Criteria:

* ASA I-II (classification of the American Society of Anesthesiologists).
* Ambulatory surgery scheduled
* Score STAI YA \> 45
* Affiliated to a social security
* Understanding the study and signing the informed consent

Exclusion Criteria:

* Contraindications for Midazolam
* Patients with disorders not compatible with virtual reality: severe cognitive or psychiatric disorders, blindness, claustrophobia, epilepsy
* Patient with a pacemaker of others implantable medical devices
* patient with burns or wounds on the upper face or scalp
* Visual hallucinations
* Contagious disease by air or indirect contact
* Person unable to express their consent
* Minor patient or patient under curatorship or guardianship
* patient participating in another interventional clinical trial

Primary outcomes:
measure: Change of Anxiety
timeFrame: D0 : baseline and right before going to surgery
Secondary outcomes:
measure: Number of milligrams of midazolam administered
timeFrame: D0 (before surgery)
measure: Percentage of patients with intraoperative remifentanil required
timeFrame: D0 (during surgery)
measure: Pain score
timeFrame: D0 (after surgery)
measure: Morphine dose used
timeFrame: D0 (after surgery in recovery room)
measure: Perioperative care satisfaction score
timeFrame: through study completion, 1 day
measure: Nature and severity of adverse events
timeFrame: through study completion, 1 day
measure: Adverse events related to the virtual reality session
timeFrame: through study completion, 1 day
measure: Virtual Reality Satisfaction Score
timeFrame: through study completion, 1 day
measure: Experience of the caregiver
timeFrame: D0 (before surgery)
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
name: Arnaud FRIGGERI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01368978: Pediatric Diabetics Type 1 Using InsuPatch
Official title: Evaluation of the Effect of lnsuPatch on the Pharmacokinetic and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs Given as a Bolus by Continuous Subcutaneous Insulin Infusion (CSII)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Keywords: TIDM
Lead sponsor: Insuline Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 27
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a prospective, single-center, open label, randomized; two-arms cross over study.

This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.

Detailed description: Twenty(20) type 1 children with Type 1 Diabetics Mellitus (TIDM) who are meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.

The study will consist of an outpatient enrollment visit and two admissions(One clamps with the InsuPatch and one clamp without the InsuPatch) . Each Subject will thus serve as his/her own control.

Eligibility criteria: Inclusion Criteria:

1. Age 12-17 (inclusive)
2. Clinical diagnosis of T1DM at least one year's duration
3. On CSII therapy for at least three months
4. Hemoglobin A1c(HBA1C) values below 10% and above 6.5%
5. Minimum weight requirements of at least 37.9 Kg.
6. Ability to comprehend written and spoken English
7. Body Mass Index z-score below 90%

Exclusion Criteria:

1. Celiac disease, gastroparesis, or other gastrointestinal disorder associated with alerted carbohydrate absorption or intestinal motility.
2. Medication besides insulin known to alter blood glucose, gastric motility, or intestinal carbohydrate absorption
3. Female subjects of reproductive potential who are pregnant or breast feeding
4. Inability to comprehend written and spoken English
5. Any other condition, which in the judgment of the investigators, would interfere with the subject's or parents' ability to provide informed consent or the investigator's ability to perform the study.
6. Hematocrit below 35 or serum potassium below 3.4 (confirmed by two samples)

Primary outcomes:
measure: Efficacy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Eda Cengiz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01244178: Hyperinsulinemic Therapy in Sepsis
Official title: Hyperinsulinemic Therapy in Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Keywords: Sepsis
Insulin
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Insulin regulates blood sugar and acts to suppress inflammation. Hyperinsulinemic Therapy is a protocol for Insulin administration that involves the administration of a calculated higher dose of insulin into the blood stream. This therapy is called dextrose/insulin clamp. It has been shown to be safe and successful in maintaining normal glucose levels.

The objective of the study is to assess if the clamp can achieve a steady and normal blood glucose level in patients admitted to the intensive care unit with sepsis. Furthermore, if the higher insulin dose would lead to a drop in the inflammatory response seen in septic patients.


Eligibility criteria: Inclusion Criteria:

* Admission to the ICU with a diagnosis of Septic shock or Severe Sepsis.

Exclusion Criteria:

* Age less than 18 years old.
* Pregnancy.
* Patients who cannot provide informed consent and there is no surrogate decision maker.
* A delay of more than 24 hours between eligibility and randomization.
* Patients admitted to the intensive care unit for treatment of diabetic ketoacidosis or hyperosmolar state.
* Imminent death.
* Patients who the treating clinicians are not committed to full supportive care. This is confirmed by a documented treatment-limitation order that exceeds a "do-not-resuscitation" order.

Primary outcomes:
measure: Glucose Control
timeFrame: During ICU stay (average one week)
Secondary outcomes:
measure: Inflammatory cytokines and biochemical hormonal response
timeFrame: At randomization then at 6,24, 120 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Riyadh
country: Saudi Arabia
facility: King Khalid Univesity Hospital
Study officials:
affiliation: McGill University
name: Peter Metrakos, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: