louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06320275: Fathers' Breastfeeding Self-efficiency
Official title: Examining the Effect of Digital Storying on Fathers' Breastfeeding Self-efficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: FATHER
BREASTFEEDING
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was planned to examine the effect of the education given through digital storytelling method on fathers' breastfeeding self-efficacy perception. The research is in a quasi-experimental design with no pretest-posttest control group.

Detailed description: In the study, intervention and control group data will be collected using the Personal Information Collection Form and the Father Breastfeeding Self-Efficacy Scale.

Personal Information Form: The Personal Information Form was developed by the researchers in line with literature information. There are questions about the socio-demographic characteristics of fathers, the role and responsibilities of fathers during breastfeeding.

Breastfeeding Self-Efficacy Scale for Fathers Short Form: The Breastfeeding Self-Efficacy Scale for Fathers was created by Dennis et al. to measure fathers' self-efficacy in supporting their spouses in breastfeeding, and its Cronbach's alpha value is 0.92.

Eligibility criteria: Inclusion Criteria:

* Not being between 0-6 weeks postpartum, not being married, not being literate

Exclusion Criteria:

-

Primary outcomes:
measure: Breastfeeding Self-Efficacy Scale for Fathers Short Form
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Balcalı
city: Adana
country: Turkey
facility: Çukurova
state: Balcalı
city: Adana
country: Turkey
facility: Çukurova University
Study officials:
References:
Clinical trial NCT02681575: Meta-cognitive Functional Intervention for Adults With ADHD: A Pilot Efficacy Study
Official title: Meta-cognitive Functional Intervention for Adults (Cog-Fun - A) With Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the initial efficacy of a psycho-social, metacognitive-functional intervention for Adults (Cog-Fun - A) with Attention Deficit Hyperactivity Disorder (ADHD).

It is hypothesized that participants in the Cog-Fun - A intervention will demonstrate improvements in measures of executive functioning, occupational performance and quality of life.

Detailed description: The Cog-Fun - A is a structured occupational therapy intervention for promoting self management in adults with ADHD. The protocol comprises three central treatment modules: Adaptive self awareness, executive strategies and skill implementation and multi-context transfer of strategies and skills.

The intervention is administered by occupational therapists on an individual basis, once a week, over 3-4 months.

20 participants will be recruited through community advertising. Sample size was determined based on expected moderate effect sizes. Data will be collected at the onset and completion of the intervention. Data will be analysed using quantitative and qualitative methods.

Adverse events if occur will be reported to supervising psychiatrist and the Helsinki Committee.

Eligibility criteria: Inclusion Criteria:

* ADHD diagnosed by certified medical practitioner
* Adult ADHD Self Report Scale (ASRS) score above cutoff
* BRIEF-A score above cutoff

Exclusion Criteria:

* Diagnoses of severe neurological or psychiatric health condition.
* Instability in pharmacological treatment
* Brief Symptom Inventory (BSI) above cutoff according to Israeli adult norms

Primary outcomes:
measure: Behavioral Ratings of Executive Functions - Adult version (BRIEF-A)
timeFrame: 3-4 months
Secondary outcomes:
measure: Adult ADHD Quality of Life Scale (AaQoL)
timeFrame: 3-4 months
measure: Canadian Occupational Performance Measure
timeFrame: 3-4 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Mount Scopus
state: Yerushalayim
Study officials:
affiliation: HMO
name: Omer Bonne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01048775: Bilateral Bispectral Index (BIS)-Monitoring in Cardiac Surgery Patients
Official title: Investigation on the Diagnostic and Predictive Value of Bilateral Bispectral Index (BIS)-Monitoring in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery Patients
Keywords: bispectral index
cardiac surgery
asymmetry
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 87
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients treated at a University Hospital

Brief summary: The bispectral index (BIS) is derived from a single-channel electroencephalogram (EEG) and provides information on the anaesthetic depth. Recently, a bilateral two-channel EEG-sensor has been introduced to monitor the BIS on both cerebral hemispheres. In some patients significant left-right differences may occur, whereas no relevant side differences are expected in the majority of patients.

The aim of this study is to

* investigate the incidence, duration and degree of left-right BIS differences
* examine the relation between BIS differences and occurrence of cognitive deficits


Eligibility criteria: Inclusion Criteria:

* patients scheduled for cardiac surgery

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: BIS side difference
timeFrame: intra- and postoperative (day 1)
Secondary outcomes:
measure: ADL = Activity of Daily Living
timeFrame: 6 month after surgery
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
Study officials:
affiliation: Dept of Anaesthesiology and Intensive Care Medicine
name: Martin Soehle, M.D., D.E.S.A., D. habil.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soehle M, Dittmann A, Ellerkmann RK, Baumgarten G, Putensen C, Guenther U. Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015 Apr 28;15:61. doi: 10.1186/s12871-015-0051-7.
Clinical trial NCT01783275: The Effect of Exercise on Hepatic Glucose Metabolism
Official title: The Effect of Exercise on Hepatic Glucose Metabolism in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Keywords: Obesity
Type 2 diabetes
Liver
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: It is known that obesity and/or physical inactivity greatly increase a person's risk of developing heart disease and other serious health problems. This is partly because diabetes is associated with inflammation, oxidative stress, and insulin resistance. Diabetes is also associated with high levels of triglycerides in the blood and tissues such as the liver (known as fatty liver or steatosis). This elevation of fat in the liver is known to cause liver insulin resistance and impair the function of the liver and this impairment contributes to the development of diabetes.

Studies have shown that both aerobic exercise and weight loss have beneficial results on insulin resistance. However, the cause of this benefit remains unclear. We know that both aerobic exercise and/or weight loss can improve how muscle responds to insulin. However, it is also known that aerobic exercise and/or weight loss lowers liver fat content, thereby making it possible that the liver's response to insulin is also improved by weight loss and/or exercise training. An improved responsiveness of the liver to insulin could lower blood sugar levels after a meal and it could also lower morning blood sugar levels. However, very little is known about how exercise and/or weight loss improves liver function in people with type 2 diabetes.

Hypothesis 1: Improved hepatic insulin sensitivity, as a result of exercise training will increase the amount of glucose from an oral load that is taken up by the liver in subjects with DM.

Hypothesis 2: Increases in hepatic insulin sensitivity as a result of exercise will cause reductions in EGP during the fasted state, and will improve the suppression of EGP seen in response to hyperinsulinemia.


Eligibility criteria: Inclusion Criteria:

* 40-60 yrs of age
* sedentary lifestyle
* stable weight
* BMI 30 - 40kg/m2
* Hgb A1c \<8.5
* Type 2 diabetes

Exclusion Criteria:

* Use of insulin
* Use of TZDs

Primary outcomes:
measure: Splanchnic glucose uptake
timeFrame: 3 years
Secondary outcomes:
measure: Endogenous glucose production
timeFrame: 3 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jason Winnick, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Naji Abumrad, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06166875: Accuracy of IVCCI as a Measure of CVP
Official title: Accuracy of Inferior Vena Cava Collapsibility Index as a Measure of Central Venous Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IVC Collapsibility Index
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 160
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 patients admitted to ICU

Brief summary: The primary aim of the current study is to examine the accuracy of IVCCI for measurement of CVP and to derive equation or formula to predict CVP from IVCCI.

Detailed description: Hemodynamic monitoring is important in the management of patients in the intensive care unit (ICU) Assessment of the intravascular volume, infusion of fluids or vasoactive drugs and maintenance of an adequate systemic perfusion is essential for reduction of the risk of organ failure and/or mortality.

The use of CVP through central venous catheter is a gold standard method that is extensively used in the ICU as it reflects the filling pressure of the right ventricle (RV) and RV preload.

Central venous cannulation has significant complications such as pneumothorax, hemothorax, arterial puncture, catheter malposition, cardiac arrhythmias, venous embolism, subcutaneous hematoma, and catheter related infection, and it is difficult to use this method in an emergency situation as it requires skilled personnel.

Measurement of IVC index by bedside ultrasound is widely used to assess the intravascular volume in adult patients and has the advantage of being non-invasive, rapid, and reliable for assessing the volume status.

Besides, related measures such as IVC diameter, IVC collapsibility, and IVC to aorta (AO) diameter have been applied clinically to assess the volume status and have been related to CVP.

Eligibility criteria: Inclusion Criteria:

* Age: ≥18 years.
* Sex: Both sexes.
* BMI: \<35
* Patient in whom central venous cannulation is needed for management.
* Spontaneously breathing patients.

Exclusion Criteria:

* Patients with increased intra abdominal pressure.
* Patients who not able to lie supine.
* Patients on mechanical ventilation.

Primary outcomes:
measure: The primary outcome of the current study is to examine the accuracy of IVCCI for measurement of CVP and to derive equation or formula to predict CVP from IVCCI.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesiology, Intensive Care, and Pain Management, Faculty of Medicine, Ain Shams University
Study officials:
References:
Clinical trial NCT01449175: A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema
Official title: A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Pulmonary Obstructive Disease
Emphysema
Keywords: AeriSeal
treatment
device
breathing
COPD
emphysema
polymeric lung volume reduction (PLVR)
biologic lung volume reduction (BLVR)
heterogeneous
homogeneous
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lead sponsor: Aeris Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-10-10
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients participating in the Registry Study must have been enrolled in either Group 4 (homogeneous emphysema) or Group 5 (heterogeneous emphysema) of Aeris' Investigational Study 03-C08-003PLV and completed 48 week follow-up in the AeriSeal post market follow-up Continuation Study (03-C10-001PLV).

Brief summary: The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.

Detailed description: The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced homogeneous or heterogeneous emphysema.

Eligibility criteria: Inclusion Criteria:

* Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.

Primary outcomes:
measure: Change in number of Serious Adverse Events (SAE)
timeFrame: Weeks 48, 96, 120, 144 following treatment
Secondary outcomes:
measure: Change in Vital Signs
timeFrame: weeks 48, 96, 120, 144 following treatment
measure: Change in Oxygen (O2) Use
timeFrame: Weeks 48, 96, 120, 144 following treatment
measure: Change in medications
timeFrame: week 48, 96, 120, 144 following treatment
measure: Change in Pulmonary Function Tests (PFT)
timeFrame: Weeks 48, 96, 120, 144 following treatment
measure: Change in notable radiology results
timeFrame: weeks 48, 96, 120, 144 following treatment
Other outcomes:
Locations:
city: Wein
country: Austria
facility: Otto Wagner Spital Wien
city: Nice
country: France
facility: Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Hemer
country: Germany
facility: LungenKlinik Hemer
city: München
country: Germany
facility: LMU Medizinische Klinik und Poliklinik Klinikum Großhadern
city: Beer Sheeva
country: Israel
facility: Soroka Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
Study officials:
References:
Clinical trial NCT06784375: Personalized Nutrition for Type 2 Diabetes
Official title: Personalized Nutrition Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Nutrition
CGM
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Prospective Randomized Trial
Primary purpose: TREATMENT

Brief summary: This project will compare medical nutrition therapy personalized by continuous glucose monitor (CGM) feedback to control interventions in participants with type 2 diabetes mellitus (T2DM).


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* previous diagnosis of T2DM
* HbA1c of 6.8-8.5%

Exclusion Criteria:

* type 1 diabetes mellitus
* treatment with insulin, sulfonylurea, or meglitinide
* use of nondiabetic medications that affect blood glucose control (such as corticosteroids)
* BMI \<25 kg/m2 or \<23 kg/m2 for participants who self-identify as Asian
* weight change \>5 pounds in the 3 months prior to study enrollment
* estimated glomerular filtration rate \<60 ml/minute/1.73 m2
* pregnancy or immediate plans to become pregnant 8) breastfeeding 9) anemia (which would affect measurement of HbA1c) 10) changes to glucose lowering medications, including change in dose, in the 3 months prior to enrollment 11) presence of any disease that would make adherence to the protocol difficult."

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Anne Bantle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06025175: Low Level Lazer Therapy Effect on Vertebral Artery Blood Flow in Elderly With Cervical Disc Degeneration
Official title: Low Level Lazer Therapy Effect on Vertebral Artery Blood Flow in Elderly With Cervical Disc Degeneration
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Disc Degeneration
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups Group (A) and group(B)
Primary purpose: TREATMENT

Brief summary: This study will include 60 elderly patients with cervical disc degeneration, from both gender who are aged from 60 - 75 years old.

Detailed description: The 60 patients will divided into two groups, with 30 patients in each group. group(A): will receive low level lazer and exercises for three times per week for 12 weeks.

Group (B): will receive only exercises. Resistivity index of both right and left vertebral arteries will be measured before and after the 12 weeks.

Eligibility criteria: Inclusion Criteria:

1. elderly patients with age range between 60 and 75 years old.
2. with cervical disc degeneration.

Exclusion Criteria:

1. patients with uncontrolled hypertension.
2. Patients with uncontrolled diabetes mellitus.
3. Patients with severe cardiac or chest diseases.

Primary outcomes:
measure: Resistivity index of both right and left vertebral arteries
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Shymaa yussuf abo zaid
Study officials:
References:
Clinical trial NCT02587975: Effect of Evogliptin on Bone Metabolism in Human
Official title: Pharmacodynamics Study to Investigate the Effect of Evogliptin on Bone Metabolism in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Osteoporosis
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal healthy women (at least 5 years)
* BMI 18\~30 kg/m2

Exclusion Criteria:

* Presence or history of hypersensitivity or allergic reactions to any drug
* Clinically relevant abnormal medical history or present disease
* Presence or history of drug abuse
* Participation in other clinical trial within 2 months before dose.
* Bood donation during 2 months or apheresis during 1 month before the study.
* Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before dose.
* Use of any drug which can affect bone metabolism such as sex hormones or their receptor related medicine, calcitonin or parathyroid hormone related medicine, systemic corticosteroid, bisphosphate, or etc.
* Smoking of more than 10 cigarettes/days within 3 months before first dose.
* Use of alcohol over 21 units/weeks
* Subject judged not eligible for study participation by investigator.

Primary outcomes:
measure: Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline
timeFrame: Predose and 1, 2, 3, 4, 6, 14, 20, 24 h postdose on Day 1 and Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggi
Study officials:
affiliation: Dongguk University College of Medicine and Ilsan Hospital
name: Namyi Gu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06862375: Weight Loss Through Mayo Clinic Diet
Official title: Weight Loss Through Mayo Clinic Diet; a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of study is to evaluate the efficacy of the Mayo Clinic Diet in clinically significant weight loss (\>5%) versus usual care. We also wish to evaluate the feasibility, barriers to completion, and sustainability of this intervention at the 24, and 52-week marks. Lastly, we aim to study the change in participants body composition and quality of life at the end of this intervention.


Eligibility criteria: Inclusion Criteria:

* Males and females (non-pregnant) 18-64
* BMI \> or = to 25 kg/m2
* Ability to read and understand English. (as the Mayo Clinic Diet book and app are only available in English)

Exclusion Criteria:

* Have a current diagnosis of melanoma or cancer diagnosis
* Currently breastfeeding
* Pregnant, or planned to be pregnant within 6 months
* Have a diagnosis of Type 1 or 2 Diabetes Mellitus
* Had weight loss surgery within the last year
* Currently participating in another lifestyle weight loss program or taking medications for weight loss
* Have lost 5% or more of their weight in the last six months
* Have a history of eating disorders
* Have planned surgery in the next 6 months.

Primary outcomes:
measure: Mayo Clinic Diet- Was It Worth It survey
timeFrame: 12 weeks, 24 weeks
Secondary outcomes:
measure: Mayo Clinic Diet 12-item Short Form health (SF-12) survey
timeFrame: Baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Tamim Rajjo
role: PRINCIPAL_INVESTIGATOR
References: