louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03863431: The Influence of Overfeeding Different Macronutrients on Whole-body Insulin Sensitivity
Official title: The Influence of Overfeeding Different Macronutrients on Whole-body Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulin Resistance
Type 2 Diabetes
Glucose Metabolism Disorders
Metabolic Disease
Keywords: High-fat diets
High-carbohydrate diets
Glycaemic control
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate the effect of high-carbohydrate vs. high-fat overfeeding (130% of energy requirements) on whole body insulin sensitivity.

Following habitual diet, participants will be randomly allocated to either a high-carbohydrate or a high-fat diet intervention for 14-days. On days 0, 7 and 14 participants will undergo anthropometric and metabolic testing (primarily an oral glucose tolerance test \[OGTT\]).


Eligibility criteria: Inclusion Criteria:

* 18-40 years
* BMI = 18.5-29.9 kg/m2
* Male or female
* Physically active (\> 3 x 30 min moderate exercise per week)
* Non-smoker (including the use of vaporisers and e-cigarettes)
* Healthy (determined by the School's standard health questionnaire)
* No cardiometabolic or inflammatory illness

Exclusion Criteria:

* Outside of age-range
* Outside BMI range
* Inactive (\< 3 x 30 min moderate exercise per week)
* Smoker
* Taking medication
* History of cardiometabolic or inflammatory illness
* Vegetarian/ vegan (as the high-fat diet is based on animal fats)
* Other dietary restrictions which prevent consumption of the experimental diet
* Consumption of probiotics within last 3 months (these influence the gut microbiota)
* Participation in another clinical trial
* Those with known or suspected food intolerances, allergies or hypersensitivity
* Women who are known to be pregnant or who are intending to become pregnant over the course of the study

Primary outcomes:
measure: Whole-body insulin sensitivity index
timeFrame: The change between pre-, during and post- dietary interventions: Assessed on days 0, 7 and 14
Secondary outcomes:
measure: Body Mass Index
timeFrame: Day 0, Day 7, Day 14
measure: Fasting plasma glucose concentration
timeFrame: Day 0, Day 7, Day 14
measure: Fasting serum insulin concentration
timeFrame: Day 0, Day 7, Day 14
measure: Fasting plasma lipid profile (for example total and HDL cholesterol and TAG concentrations; all measured in mmol/L)
timeFrame: Day 0, Day 7, Day 14
measure: Indirect calorimetry
timeFrame: Day 0, Day 7, Day 14
measure: Subjective appetite ratings
timeFrame: Day 0, Day 7, Day 14
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: School of Sport, Exercise and Health Sciences
state: Leicestershire
Study officials:
affiliation: Loughborough University
name: Carl Hulston, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06689631: Mucociliary Clearance Techniques for Acute Bronchiolitis
Official title: Efficacy of Mucociliary Clearance Techniques in Non-hospitalised Infants with Acute Bronchiolitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Bronchiolitis Due to Respiratory Syncytial Virus
Bronchiolitis Acute
Bronchiolitis Acute Viral
Keywords: mucociliary clearance
respiratory physiotherapy
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 70
Sex: ALL
Minimum age (years): 28
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of mucociliary clearance techniques in non-hospitalised infants with a first episode of mild to moderate acute bronchiolitis.


Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of first episode of acute Bronchiolitis.
* Acute Bronchiolitis with mild (ESBA score = 1-4) or moderate (ESBA score =5-9) severity according to the ESBA.
* Informed consent signed by parents or legal guardians.

Exclusion Criteria:

* Infants previously diagnosed with chronic respiratory disease.
* Previous episodes of wheezing.
* Presence of any type of contraindication to receive Respiratory Physiotherapy treatment.

Primary outcomes:
measure: ESBA
timeFrame: 1 session (45 minutes)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gonzalez Bellido V, Velaz Baza V, Esteo MDCJ, Carballo RG, Colombo A, Zaldivar JNC, Donadio MVF. Safety of airway clearance combined with bronchodilator and hypertonic saline in non-hospitalized infants with acute bronchiolitis. Arch Pediatr. 2021 Nov;28(8):707-711. doi: 10.1016/j.arcped.2021.09.007. Epub 2021 Oct 5.
Clinical trial NCT03521531: Burden and Medical Care of Sarcoma in Germany
Official title: Burden and Medical Care of Sarcoma in Germany: Nationwide Cohort Study Focusing on Modifiable Determinants of Patient-Reported Outcome Measures in Sarcoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: Quality of Life
Sarcoma
Patient Reported Outcomes
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 1309
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: All sarcoma patients treated, diagnoses or been in aftercare in a German hospital or medical practice.

Brief summary: The main objective of the study is to assess the treatment situation of sarcoma patients in Germany and to investigate their potential influence on Quality of Life (and other Patient Reported Outcomes) of the affected persons. Impaired quality of life domains and factors associated with it are to be identified.

To this end, a national network of sarcoma treatment specialists and a structure for patient recruitment will be established. This care network is intended to reflect the current situation of the treatment of sarcoma patients in Germany.


Eligibility criteria: Inclusion Criteria:

* patients with sarcoma diagnosis according to International Classification of Diseases for Oncology (ICD-O) and World Health Organisation (WHO) classification

Exclusion Criteria:

* not mentally able to fill out questionaires
* not able to till out questionaires in German

Primary outcomes:
measure: Quality of Life - EORTC QLQ-C30
timeFrame: 1 year
Secondary outcomes:
measure: Pain - Intensity (BPI)
timeFrame: 1 year
measure: Psychological Distress - PHQ-4
timeFrame: 1 year
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Dresden
state: Saxony
Study officials:
affiliation: Technical University Dresden, Medical Faculty
name: Markus Schuler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Technical University Dresden, Medical Faculty
name: Jochen Schmitt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eichler M, Hentschel L, Singer S, Hornemann B, Hohenberger P, Kasper B, Andreou D, Pink D, Jakob J, Arndt K, Kirchberg J, Richter S, Bornhauser M, Schmitt J, Schuler MK. Distress in soft-tissue sarcoma and gastrointestinal stromal tumours patients-Results of a German multicentre observational study (PROSa). Psychooncology. 2022 Oct;31(10):1700-1710. doi: 10.1002/pon.6009. Epub 2022 Aug 18.
Clinical trial NCT00816231: Drug /Cue Interactions In Alcohol-Tobacco Comorbidity
Official title: Drug /Cue Interactions In Alcohol-Tobacco Comorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: Prevention Intervention
Alcohol
Tobacco
Nicotine
Craving
Cue Reactivity
Cross Cue Reactions
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-01-01
Enrollment: 244
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine how people react to different combinations of alcohol and nicotine.

Detailed description: The present project will improve and expand upon previously published work in several ways. First, Study 1 will assess reactivity to alcohol and smoking cues in the same session. Second, both studies will include within-subjects design factors to manipulate alcohol and nicotine intake, as well as cue types. Third, craving indices will represent three important response domains: subjective, physiological, and behavioral (e.g., Niaura et al., 1991). Fourth, each study will evaluate a range of drinkers and smokers, which will provide maximal information concerning influences on alcohol and smoking cue reactivity across various subject populations. The proposed studies are not only important from a theory development perspective, but they will provide an excellent foundation for future laboratory-based and clinical research.

Eligibility criteria: Inclusion Criteria:

* English speaking persons who exhibit a range of alcohol consumption and smoking patterns.
* Signed written consent form.

Exclusion Criteria:

* Females who are pregnant, nursing, or not using effective methods of birth control will be excluded from participating.

Primary outcomes:
measure: Psychophysiological Reactivity Assessment
timeFrame: approximately 5 weeks per participant
Secondary outcomes:
measure: Alcohol Self-administration Assessment
timeFrame: approximately 5 weeks per participant.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: David Drobes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01784731: User Charges for General Practitioner Services in Denmark
Official title: Brugerbetaling i Almen Praksis (In Danish: User Charges for General Practitioner Services)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Consequences of User Charges
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled with a general practitioner clinic

Brief summary: Currently, office visits at general practitioners is free of charge for patients. However, public commissions and the Danish Economic Council have suggested to implement user charges for services that currently is free of charge. The aim of this study is to examine the consequences of introducing user charges for general practitioner services. Data for the project will be collected from patients who have an appointment with a general practitioner. Patients will be asked whether they are willing to pay a specified amount for the consultation that they have scheduled. After the consultation, the GP register diagnoses.


Eligibility criteria: Inclusion Criteria:

* Patients with an appointment for a visit in a general practitioner clinic
* Reads and understand Danish

Exclusion Criteria:

-

Primary outcomes:
measure: Willingness to pay
timeFrame: once
Secondary outcomes:
measure: Diagnoses
timeFrame: Once
Other outcomes:
Locations:
city: Nyborg
country: Denmark
facility: Lægerne Nyenstad
Study officials:
References:
citation: Kronborg C, Pedersen LB, Fournaise A, Kronborg CN. User Fees in General Practice: Willingness to Pay and Potential Substitution Patterns-Results from a Danish GP Patient Survey. Appl Health Econ Health Policy. 2017 Oct;15(5):615-624. doi: 10.1007/s40258-017-0325-y.
Clinical trial NCT00005731: Develop and Implement Asthma Controlling Strategies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY

Brief summary: To develop and implement asthma-controlling educational strategies for inner city and high risk populations.

Detailed description: BACKGROUND:

Asthma is a serious chronic disease affecting about 12 million Americans; about 3 million are children. The study was part of an initiative, "Developing and Implementing at the State and Local Level Educational Strategies and Interventions for Controlling Asthma in Inner City and High Risk Populations", released in February 1993 by the National Asthma Education Program of the Office of Prevention, Education and Control.

DESIGN NARRATIVE:

A computer-assisted multimedia instructional and feedback system, "Asthma Patient/Provider Partnership System" (APPPS), was developed for African American and Hispanic school-age children that was suited for adoption and implementation in clinical and other settings based on the National Asthma Education Program's Expert Panel Guidelines on the Diagnosis and Management of Asthma. A formative evaluation of the educational intervention was conducted. Also, an efficacy study of the intervention in three clinical settings was conducted and the findings of this study were incorporated into the APPPS. Finally, a recommended dissemination strategy was prepared for diffusion of the system to other settings.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bartholomew LK, Gold RS, Parcel GS, Czyzewski DI, Sockrider MM, Fernandez M, Shegog R, Swank P. Watch, Discover, Think, and Act: evaluation of computer-assisted instruction to improve asthma self-management in inner-city children. Patient Educ Couns. 2000 Feb;39(2-3):269-80. doi: 10.1016/s0738-3991(99)00046-4.
citation: Bartholomew LK, Shegog R, Parcel GS, Gold RS, Fernandez M, Czyzewski DI, Sockrider MM, Berlin N. Watch, Discover, Think, and Act: a model for patient education program development. Patient Educ Couns. 2000 Feb;39(2-3):253-68. doi: 10.1016/s0738-3991(99)00045-2.
Clinical trial NCT06612931: Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures
Official title: Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures: a Multicenter, Randomized, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP)
Miniforceps Biopsy
Biliary Strictures
Brush Cytology
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Xijing Hospital of Digestive Diseases
name: Eastern Hepatobiliary Surgery Hospital
First posted: 2024-09-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: In this randomized crossover trial involving patients with indeterminate biliary strictures, we aimed to compare the diagnostic performance of the dual-lumen catheter-guided miniforceps biopsy (CMB) device with that of brush cytology under aspiration (BCA).


Eligibility criteria: Inclusion Criteria:

* Aged between 18-88 years old.
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
* Biliary obstructive symptoms,or indeterminate biliary stricture suspected to be intrinsic based on prior imaging.

Exclusion Criteria:

* Any contraindications to ERCP.
* Severe cardiopulmonary disease or coagulopathy.
* Biliary strictures caused by extrinsic compression.
* Unwillingness or inability to provide consent.
* Pregnant or breastfeeding women.

Primary outcomes:
measure: The diagnostic accuracy
timeFrame: 6 months
Secondary outcomes:
measure: the diagnostic sensitivity
timeFrame: 6 months
measure: The diagnostic specificity
timeFrame: 6 months
measure: Severe adverse events rates
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
name: Baiwen Li, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00245531: Effects of Endocrine Health on Mental Performance of Men and Women Using Drugs
Official title: Effects of Endocrine Health on the Cognitive Function of Men and Women Using Drugs: A Cross-sectional Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus Positive or Negative
Keywords: endocrine abnormalities
cognitive performance
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-10-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: males and females 18-50 years old who have completed the 8th grade and are using drugs

Brief summary: The purpose of this study is to understand the effects of decreased functioning of the testes or ovaries on mental performance in males and females using illicit drugs excluding marijuana.

Detailed description: This research is being done to understand the effects of endocrine abnormalities, specifically hypogonadism (decreased functioning of the testes or ovaries) on cognitive (mental) performance in males and females using illicit drugs (excluding marijuana).

Eligibility criteria: Inclusion Criteria:

* Completed the 8th grade

Exclusion Criteria:

* Did not complete the 8th grade. Have a hormone problem for which you are taking medication e.g. testosterone or thyroid medicine, steroids, oral contraceptives, progesterone. Diagnosed with cancer. History of schizophrenia. Currently have or have been diagnosed in the past with meningitis or encephalitis.

Primary outcomes:
measure: Cognitive function
timeFrame: 12 weeks
Secondary outcomes:
measure: Gonadal hormones
timeFrame: 12 weeks
Other outcomes:
measure: Quality of life
timeFrame: 12 weeks
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University, The Clinical Trials Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Adrian S Dobs, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zilbermint MF, Wisniewski AB, Xu X, Selnes OA, Dobs AS. Relationship between sex hormones and cognitive performance in men with substance use. Drug Alcohol Depend. 2013 Mar 1;128(3):250-4. doi: 10.1016/j.drugalcdep.2012.08.024. Epub 2012 Sep 26.
Clinical trial NCT01696331: Text Messaging for Adherence in Adolescent Liver Transplant Recipients
Official title: Impact of Text Messaging on Adherence in Adolescent Liver Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant
Adherence
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Text message reminders will improve adherence to lab tests in adolescent liver transplant recipients.

Detailed description: Adolescent patients who received a liver transplant will be recruited to participate in receiving text message reminders for lab tests. They will be send de-identified messages according to their required lab schedule. The investigators will monitor their adherence to lab tests as well as medication and clinic visits. They will also have a questionnaire about their medical regimen before and at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Patient \>12 years
* Received liver transplant
* Followed by Stanford Liver Transplant Team

Exclusion Criteria:

* No personal cell phone

Primary outcomes:
measure: Adherence to lab tests
timeFrame: One year
Secondary outcomes:
measure: Texting responses
timeFrame: 1 year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
References:
Clinical trial NCT00608231: Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
Official title: Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Parkinson's Disease
Essential Tremor
Dystonia
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-02-06
Enrollment: 0
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: To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings

Detailed description: Deep brain stimulator (DBS) implants are used in the treatment of medically refractory movement disorders such as Parkinson's disease, essential tremor and dystonia. Because of the uniqueness of each individual brain, the surgery to implant a DBS electrode requires detailed anatomic and physiological information for each patient. The anatomic data is obtained before surgery via a Magnetic Resonance Imaging (MRI) scan of the patient's brain. Physiological data is obtained during the operation via micro-electrode recording of the patient's brain and neurological examination of the patient. Therefore, DBS surgery can be uncomfortable to patients, as it can be very time consuming and requires the patient to be awake and attentive.

The specific aims of this project are:

1. To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings.
2. To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery have no significant effects on neurological findings and/or patient cooperation during neurological examination.

Eligibility criteria: Inclusion Criteria:

* Any patient who has agreed to undergo DBS implantation.

Exclusion Criteria:

* Patients who fail recommendation for DBS surgery discussed in Vanderbilt University Movement Disorder Clinical Conference.
* Patients not consented for DBS surgery.
* Patients or legal guardians not able to provide informed consent.

Primary outcomes:
measure: Micro-electrode Recordings
timeFrame: Intra-operative
Secondary outcomes:
measure: Neurological Exam Findings
timeFrame: Intra-operative
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Joseph Neimat, M.D.
role: PRINCIPAL_INVESTIGATOR
References: