louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02133040: Effects of Hyperthyroidism on Amount and Activity of Brown Adipose Tissue
Official title: Identification and Regulation of Brown Adipose Tissue (BAT) in Humans. Implications for Energy Expenditure in Humans and in the Treatment of Obesity and Related Metabolic Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperthyroidism
Keywords: Brown Adipose Tissue
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2014-05-07
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 patients with hyperthyroidism, reffered to our hospital from their primary caretakers will be investigated before and after 3 to 5 months in a proven euthyroid state.

Brief summary: The investigators wish to evaluate the effect of thyroid hormones on brown adipose tissue in humans in an observational study on patients with thyrotoxicosis. In the investigators evaluation the investigators will use FDG-PET/CT, indirect calorimetry and fat biopsies in the acute phase of the disease and in the euthyroid phase after treatment.

It is the investigators hypothesis that high levels of circulating T3 might affect amount and function of brown adipose tissue.

Detailed description: 10 patients with thyreotoxicosis (T3 \> 3 nmol/L and suppressed TSH) will be investigated at diagnosis and after 3-6 months of euthyroidism induced by antithyroid treatment. The patients will all be over the age of 50 due to the radiation given by the scans (requested by the local Ethical Committee). All will be scanned for active BAT by the integrated FDG PET-CT before and after treatment.BAT is activated by means of crushed ice placed under the feet in individualized intervals during the scan procedure. Indirect calorimetry is done to determine the basal metabolic rate and subcutaneous fat biopsy to examine the effect on subcutaneous white fat and the possible "browning" effect.

Eligibility criteria: Inclusion Criteria:

* men and women with hyperthyroidism (T3 \> 3 nmol/l)
* \> 50 years old
* women must be postmenopausal

Exclusion Criteria:

* thyrotoxic crises
* severe concurrent sickness that will make it unsafe to postpone treatment, this includes severe kidney disease (creatinin over 160)- and heart disease (NYHA group 3 and 4).
* diabetes
* former and current treatment with interleukin-2
* Patients who are already treated with β-blockers
* severe claustrophobia
* BMI \> 30 kg/m2

Primary outcomes:
measure: FDG-PET/CT-scanning
timeFrame: 6 months
Secondary outcomes:
measure: Indirect Calorimetry
timeFrame: 6 months
Other outcomes:
measure: Changes in adrenergic receptor status and UCP1, PGC1alpha, PRDM16 and Dio2 levels in subcutaneous fat depots
timeFrame: 6 months
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Region Midtjylland
Study officials:
affiliation: University of Aarhus
name: Bjørn Richelsen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01039740: Pharmacogenetic Study of Mirtazapine Response in Depressed Patients
Official title: Pharmacogenetic Study of Mirtazapine Response in Depressed Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Pharmacogenomics
Prediction of Mirtazapine response
Depressed patients
Mirtazapine response
Adverse event
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-12-25
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pharmacogenetic study predict Mirtazapine responsiveness in advance before the appearance of the drug effect until 4-6 weeks after administration of Mirtazapine.

Detailed description: The purpose of this study is

1. to determine whether genomic differences between drug responders and nonresponders predict the response of Mirtazapine and
2. to construct the prediction model for Mirtazapine treatment in depressed patients in order to aid to select the genetically matching drug.

Eligibility criteria: Inclusion Criteria:

1. Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
2. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.

Primary outcomes:
measure: Mirtazapine response at 2,4,6 weeks and adverse events (A/E) monitoring at 1,2,4,6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Biological value at 0 and 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kangnam
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
Study officials:
affiliation: Samsung Medical Center
name: Doh Kwan Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03513640: Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants
Official title: Prospective Cohort for Finding Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meconium Obstruction of Prematurity
Respiratory Distress Syndrome in Premature Infant
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 48
Sex: ALL
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants born less than 34 weeks who were admitted in neonatal intensive care unit at Seoul National University Children's Hospital

Brief summary: Although the pathophysiology of meconium obstruction of prematurity (MOP) is not clear, it is known that the decrease of the intestinal peristalsis due to decreased intestinal perfusion during antenatal or perinatal period. Recently, the level of citrulline has been used as an index of function and injury of the small intestine State. This study aimed to evaluate citrulline level of cord blood as a marker for early detection and observe changes in intestinal blood flow in MOP patient.

And We aimed to confirm the efficacy of the AT/ET ratio (ratio of the pulmonary artery time-to-peak velocity interval to the right ventricular ejection time) of the prenatal pulmonary artery as a noninvasive predictor of neonatal respiratory distress syndrome.


Eligibility criteria: Inclusion Criteria:

* premature infants born less than 34 weeks from mother with pregnancy induced hypertension, pre-eclampsia or eclampsia

Exclusion Criteria:

* major congenital anomalies
* infants with hypotension while using inotropics

Primary outcomes:
measure: Comparison of citrulline level between the meconium obstruction group and the normal feeding advance group
timeFrame: within 6 hours after birth
measure: Comparison of prenatal AT/ET ratio of fetal pulmonary artery between respiratory distress syndrome group and the normal respiration group
timeFrame: within 10 days before delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06484140: Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
Official title: Evaluation of the Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Financial Toxicity
Financial Navigation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to access the impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.

The main questions it aims to answer are:

* Does the intervention alleviate participants' financial toxicity?
* Does the intervention enhance participants' cost-related health literacy?
* Does the intervention improve participants' shared decision-making?
* Does the intervention reduce participants' perceived stress?

Researchers will compare the financial navigation program with usual oncology care to evaluate its effectiveness.

Participants will receive the comprehensive financial navigation, including:

* Needs assessment;
* Cost-related health education, mainly including topics regarding communication of cost, treatment-related cost, health insurance policies, and family support;
* Resource and service referral;
* Personalized counseling.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with breast cancer and undergoing surgery during this admission;
* Female, age 18 years or older;
* Receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy;
* Eastern Cooperative Oncology Group Performance Status 0-2;
* Provided informed consent to participate in this study.

Exclusion Criteria:

* Diagnosed with ductal carcinoma in situ (DCIS)
* Presence of any serious psychiatric disorders;
* Cognitive impairments;
* Difficulty in reading, writing, or communicating in Chinese.

Primary outcomes:
measure: Financial toxicity
timeFrame: Baseline, 1st month and 3rd month since baseline
measure: Material domain of financial toxicity
timeFrame: 1st month and 3rd month since baseline
measure: Behavioral domain of financial toxicity
timeFrame: 1st month and 3rd month since baseline
Secondary outcomes:
measure: Cost-related health literacy
timeFrame: Baseline, 1st month and 3rd month since baseline
measure: Shared decision-making
timeFrame: Baseline, 1st month and 3rd month since baseline
measure: Perceived stress
timeFrame: Baseline, 1st month and 3rd month since baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT03824340: Intracytoplasmic Sperm Injection Preparation in Infertile Women
Official title: Intracytoplasmic Sperm Injection Preparation in Infertile Women With Unexplained Infertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled study
Primary purpose: TREATMENT

Brief summary: Infertility is a common gynecological problem is women

Detailed description: Intracytoplasmic sperm injection is one of the aisted reproduction techniques that help to solve this problem

Eligibility criteria: Inclusion Criteria:

* Women who have infertility with age between 20 -42 years

Exclusion Criteria:

* women who has ovarian or endometrial factor of infertility

Primary outcomes:
measure: the number of women who will have successful ICSI
timeFrame: within 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03247140: The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers
Official title: An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Coadministration of Rosuvastatin and Telmisartan/Amlodipine in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension With Dyslipidemia
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-11
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
* Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* Systolic BP \> 140mmHG or Diastolic BP \> 90mmHg)
* AST or ALT \> X 2 UNL
* History of drug abuse or positive drug screening.
* Participation in other drug studies within 3 months prior to the drug administration.
* Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Primary outcomes:
measure: AUC
timeFrame: 72hr after baseline
measure: Cmax
timeFrame: 72 after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Min Gul Kim, MD., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03667040: E-health Resilience Program For Chronic Spine Pain
Official title: A Randomized Controlled Trial of an E-health Resilience Program For Chronic Spine Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Back Pain
Neck Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 150 participants will be recruited; 75 participants into the intervention group and 75 into the control group. There will three visits, baseline and follow-up at 30 days and 60 days.
Primary purpose: TREATMENT

Brief summary: This study will examine a e-health resilience based program, JOOL, for chronic spine pain patients through the following aims:

Aim 1: To test the effectiveness of a resilience based program known as JOOL Aim 2: To evaluate the characteristics of the participants most likely to benefit from this treatment

Detailed description: This is a pilot RCT in which 150 patients with chronic spine pain will be randomized to one of two arms: (1) a group that downloads the JOOL mobile application resilience program; and (2) a control group.The primary outcome will be a change in physical function.

Eligibility criteria: Inclusion Criteria:

* Patient of the UM Back \& Pain Center
* Primary diagnosis of neck or back pain (spine pain)
* Age 18-70
* English speaking
* Able to provide consent
* Willing to download the mobile application and comply with study procedures
* Antidepressant medications stable for ≥ 4 weeks
* No plan to initiate a new non-pharmacological pain intervention during the 30-day study period (e.g. back surgery, physical therapy, behavioral therapy

Exclusion Criteria

* Having known psychotic disorder or the presence of another psychiatric condition (e.g. severe depression \[HADS scores ≥ 15\], suicidal ideation) or cognitive impairment (e.g. severe dyslexia, TBI) limiting ability to give consent and/or participate fully in the study
* Currently undergoing psychotherapeutic care at the Back \& Pain Center because many of the concepts that are the focus of this study are already employed in that treatment
* Other factors that at the discretion of the investigators would adversely affect study participation.

Primary outcomes:
measure: PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Scale- Short form 10
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Back & Pain Center, University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Afton Hassett, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04418440: Nutritional Treatment for the Amelioration of Traumatic Brain Injury
Official title: Nutritional Treatment for the Amelioration of Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To test the feasibility of administering a commercially available neurotrophic oral nutritional supplement (ONS) for adult patients with acute traumatic brain injury at the Royal London Hospital.

Detailed description: The study will be a randomised controlled non-blinded trial of adult patients with acute traumatic brain injury at the Royal London Hospital.

There will be randomisation to one of two non-blinded trial groups:

1. Usual standard NHS care (control group)
2. Usual standard NHS care plus daily oral dose of Souvenaid® ONS

The trial protocol will commence between 3-7 days after admission. The trial timeline provides a summary of intervention and assessments.

The trial will last 12 months. The first 6 months will be the formal trial with two groups and follow up assessments. This will be performed on intention to treat basis. After this initial phase the investigators will provide an opportunity for all participants from either group (control or treatment) to take Souvenaid® ONS for a further 6 months with a clinical follow up appointment.

Eligibility criteria: Inclusion Criteria:

* Adult between 18 yrs and 80 yrs of age
* Acute traumatic brain injury with confirmed radiological features

Exclusion Criteria:

* Allergies to fish oil/milk/soya
* Medical history of galactosaemia
* Non-traumatic aetiology to head injury
* Unable to receive enteral nutrition
* Craniectomy during admission (loss of integrity of skull convexity)
* Concurrent active neurological disease
* Pregnancy or breastfeeding

Primary outcomes:
measure: Feasibility to conduct the protocol as stated
timeFrame: 10 months
Secondary outcomes:
measure: Brain network connectivity
timeFrame: 10 months
measure: Cognitive function
timeFrame: 10 months
measure: Plasma phospholipid levels
timeFrame: 10 months
measure: Omega-3 index
timeFrame: 10 months
measure: Neurofilament light levels
timeFrame: 10 months
measure: Inflammatory markers
timeFrame: 10 months
measure: C-reactive protein
timeFrame: 10 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Bart Health, Royal London Hospital
Study officials:
affiliation: Barts Health
name: Chris Uff
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02654301: Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia
Official title: Beneficial Effect of Xylose Consumption on Postprandial Hyperglycemia in Subjects With Normal Glucose Level and Impaired Fasting Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Keywords: Xylose
prediabetes
postprandial hyperglycemia
glucose
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The present study determined the effect of Xylose consumption on postprandial hyperglycemia in normal (n=25) and hyperglycemic subjects (n=50).

Detailed description: In this double-blind crossover designed study, Participants were randomly assigned to consume a sucrose drink (Control, sucrose 50g + deionized water 100g) or a sucrose drink additionally containing 5 g (Test 1, sucrose : xylose = 10:1), 3.33 g (Test 2, sucrose : xylose = 15:1) or 2.5 g (Test 3, sucrose : xylose = 20:1) of D-xylose with a week interval.

Eligibility criteria: Inclusion Criteria:

1) healthy subject or Impaired fasting glucose (fasting serum glucose between 100 and 125 mg/dL)

Exclusion Criteria:

1. history of taking an insulin-injection or oral hypoglycemic agents
2. evidence of alcohol abuse or alcoholism
3. pregnancy or breast feeding
4. chronic gastrointestinal disorder
5. seriously abnormal liver or renal function
6. an occupation at risk of death when hypoglycemia occurs

Primary outcomes:
measure: Change of serum glucose levels
timeFrame: a week interval
Secondary outcomes:
measure: Change of serum insulin levels
timeFrame: a week interval
measure: Change of serum C-peptide levels
timeFrame: a week interval
Other outcomes:
Locations:
Study officials:
affiliation: Laboratory of clinical nutrigenetics/nutrigenomics, Yonsei University
name: Jong Ho Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jun YJ, Lee J, Hwang S, Kwak JH, Ahn HY, Bak YK, Koh J, Lee JH. Beneficial effect of xylose consumption on postprandial hyperglycemia in Korean: a randomized double-blind, crossover design. Trials. 2016 Mar 15;17(1):139. doi: 10.1186/s13063-016-1261-0.