louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03297879: Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes
Official title: Beijing Chao-Yang Hospital, Capital Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type2 Diabetes
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 230
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study assessed the therapeutic effect of exenatide and metformin as the initial therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).

Detailed description: The present study was a prospective, nonrandomized, interventional study.The drug-naïve, overweight or obese patients with newly diagnosed T2D were consecutively enrolled. The inclusion criteria: 1) age 20 - \<65 years, 2) body mass index (BMI) ≥ 24 kg/m2 \[7\], and 3) HbA1c ≥ 7% (53mmol/mol). An oral glucose tolerance test was performed during the screenings. All of the patients have no diabetes antibodies and were diagnosed with T2D within the previous 3 months, according to the ADA diagnostic criteria. None of the patients had administered anti-diabetic drugs or diet therapy before participation. Neither of the patients presented any history of pancreatitis, coronary artery disease, liver function impairment, renal function impairment, intestinal surgery, chronic hypoxic diseases (emphysema and cor pulmonale), infectious disease, hematological disease, systemic inflammatory disease, or cancer. Patients who were pregnant, possibly pregnant, or ingesting agents known to influence glucose or lipid metabolism were also excluded.

Eligibility criteria: Inclusion Criteria:

* age 20 - \<65 years,
* body mass index (BMI) ≥ 24 kg/m2,
* HbA1c ≥ 7% (53mmol/mol).
* diabetes antibodies (-)
* diagnosed with T2D within the previous 3 months

Exclusion Criteria:

* anti-diabetic drugs or diet therapy before participation
* pancreatitis
* coronary artery disease
* liver function impairment
* renal function impairment
* intestinal surgery
* chronic hypoxic diseases (emphysema and cor pulmonale)
* infectious disease
* hematological disease
* systemic inflammatory disease
* cancer
* pregnant, possibly pregnant
* ingesting agents known to influence glucose or lipid metabolism

Primary outcomes:
measure: The change of HbA1c
timeFrame: baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zhang L, Hu Y, An Y, Wang Q, Liu J, Wang G. The Changes of Lipidomic Profiles Reveal Therapeutic Effects of Exenatide in Patients With Type 2 Diabetes. Front Endocrinol (Lausanne). 2022 Mar 31;13:677202. doi: 10.3389/fendo.2022.677202. eCollection 2022.
citation: Liu J, Hu Y, Xu Y, Jia Y, Miao L, Wang G. Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients with Newly Diagnosed Type 2 Diabetes. Int J Endocrinol. 2017;2017:9401606. doi: 10.1155/2017/9401606. Epub 2017 Nov 20.
Clinical trial NCT02597179: Genome Sequencing in Refractory Breast Cancer to Molecular Targeted Therapy and Young Breast Cancer
Official title: Genome Sequencing in Refractory Breast Cancer to Molecular Targeted Therapy and Young Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 350
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Histologically or cytologically conrfirmed breast cancer that is either metastatic or young breast cancer(≤ 40 years of age) with feasible biopsy site.

Brief summary: The purpose of this study is to investigate and analyse genomic profiles in patient with breast cancer who failed standard treatment, refractory and young breast cancer.

Detailed description: The hypothesis is that genomic profiling measured by CancerSCAN, cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be helpful to find out tolerance for chemotherapy and innovate new therapeutic strategies.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed breast cancer that is either metastatic or young breast cancer(≤ 40 years of age).
2. HER2 positive patient who failed HER2 target therapy including trastuzumab with feasible biopsy site.
3. Triple Negative Breast Cancer patient who failed standard therapy with feasible biopsy site.
4. Hormone Receptor positive patient who failed standard therapy with feasible biopsy site.
5. Age ≥ 21 years
6. Written informed consent

Exclusion Criteria:

1. No feasible biopsy site
2. No written informed consent

Primary outcomes:
measure: Number of Participants With Mutated Genes and/or Abnormal Gene expression and/or Different Immune signature That Affect to Treatment Outcome.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-Gu
Study officials:
References:
Clinical trial NCT00996879: Study to Assess the Effect of BMS-791325 on the Pharmacokinetics of Midazolam in Healthy Subjects
Official title: Study to Evaluate the Effect of BMS-791325 on the Pharmacokinetics of the CYP3A4 Probe Midazolam Administered Orally in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Human Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects aged 18 to 49 years, with BMI of 18-32 kg/m²
* Women who are not of childbearing potential

Exclusion Criteria:

* Women of childbearing potential
* Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
* Gastrointestinal disease that may impact the absorption of study drug
* History of any chronic respiratory disease (asthma, COPD)

Primary outcomes:
measure: Pharmacokinetics parameters area under curve (AUC) (TAU), maximum concentration (Cmax)
timeFrame: Within 24 hours of dosing
Secondary outcomes:
measure: Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examination and clinical laboratory tests
timeFrame: On Days 1, 2, 4, 6, 8, 9, and 10
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Wcct Global, Llc
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04912479: Can Connected Devices Increase the Success Rate of Benzodiazepine Withdrawals in the Elderly?
Official title: Can Connected Devices Increase the Success Rate of Benzodiazepine Withdrawals in the Elderly?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benzodiazepine Withdrawal
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a prospective randomized open study, which aims to evaluate the benefit of a connected watch to help people aged 65 years and older to withdraw from BZD over a six-month period, compared with classical withdrawal (e.g without connected watch). The study will include 100 patients, 50 in the control group and 50 in the intervention group.

Participants will be identified during a 12-month period through either external geriatric consultations or during a brief hospitalisation.

Detailed description: Despite a trivialized use of benzodiazepine (BZD) in elderly people (EP), long-term efficacy is often questioned, and treatment has to be regularly re-examined to avoid side effects. Typical intervention techniques to aid patients in reducing their dosage involve: providing information about BZD, explaining the risks associated with a chronic exposure, and tips for a successful withdrawal. In addition, the usage of a connected device may reinforce the patient's motivation by providing details on the quality of sleep and the number of steps taken (activity).

This is a prospective randomized open study, which aims to evaluate the benefit of a connected watch to help people aged 65 years and older to withdraw from BZD over a six-month period, compared with classical withdrawal (e.g without connected watch). The study will include 100 patients, 50 in the control group and 50 in the intervention group.

Participants will be identified during a 12-month period through either external geriatric consultations or during a brief hospitalisation.

Eligibility criteria: Inclusion Criteria:

* Unassisted mobility (1/1 for the locomotion item on KATZ Activities of Daily Living scale)
* Mini-Mental State Examination (MMSE) ≥ 20
* With a daily consumption of benzodiazepine for more than 3 months
* Smartphone and/or tablet with internet connection

Exclusion Criteria:

* Patient under legal protection
* Patient refuses to participate
* Patient does not speak French

Primary outcomes:
measure: success to stop or reduce benzodiazepine consumption
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Cécile McCambridge
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06043479: Evaluation of the Effectiveness of the Training Given to Mothers With 0-5 Age Group Children for Fire Management
Official title: Evaluation of the Effectiveness of the Training Given to Mothers With 0-5 Age Group Children for Fire Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Keywords: Child
fever,
mother,
fever management,
education
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group and intervention group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research was conducted in a randomized controlled design to evaluate the effectiveness of the fever management training given to mothers of children aged 0-5.

Detailed description: The research was conducted between January 2023 and April 2023 in the Pediatric Ward of Gebze Fatih State Hospital. The study included 120 mothers, with 60 in the intervention group and 60 in the control group, who had children aged 0-5 years old admitted to the hospital with a complaint of fever. The data was collected using the 'Mother and Child Information Form,' 'Parent's Fever Management Scale (PFMS),' 'Fever Management Knowledge Statements Form (FMKSF),' and 'Follow-up Form. The data were analyzed using appropriate statistical methods in the SPSS (Statistical Package for Social Sciences) for Windows 26.0 software package.

Eligibility criteria: Inclusion Criteria:

* Mothers with 0-5 age group children in fever
* Must be literate

Exclusion Criteria:

* Discharge before 3 days

Primary outcomes:
measure: Mother and Child Information Form
timeFrame: baseline
measure: The Parent Fever Management Scale (PFMS)
timeFrame: baseline and 3 days and 1 month
measure: The Fever Management Knowledge Statements Form
timeFrame: baseline and 3 days and 1 month
measure: The Follow-up Form
timeFrame: through study completion, an average of 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Gebze
country: Turkey
facility: .Demet Yildirim
state: Kocaeli̇
Study officials:
affiliation: Tarsus University
name: Nadiye Barış Eren
role: STUDY_DIRECTOR
References:
Clinical trial NCT05670379: Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant
Official title: A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Exenatide Implant
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Overweight and Obesity
Type2diabetes
Lead sponsor: Vivani Medical, Inc
Sponsor class: INDUSTRY
Collaborators: name: Avance Clinical Pty Ltd.
First posted: 2023-01-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.


Eligibility criteria: Inclusion Criteria:

* BMI 27 to 40 kg/m\^2
* Estimated glomerular filtration rate (eGFR) \>/= 90 mL/min/1.73 m\^2
* HbA1c \< 6.0% and FPG \< 6.7 mol/L

Exclusion Criteria:

* Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being
* History of Type 1 or Type 2 Diabetes
* History of, or currently has, acute or chronic pancreatitis or has triglyceride concentrations ≥500 mg/dL
* Has medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN II) or a family history of MTC or MEN II
* Current or past exposure to exenatide

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: 9 weeks
measure: Maximum plasma concentration observed (Cmax)
timeFrame: 9 weeks
measure: Time to maximum plasma concentration observed (Tmax)
timeFrame: 9 weeks
measure: Adverse events
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMax
Study officials:
affiliation: Vivani Medical, Inc
name: Lisa Porter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00392379: Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
Official title: Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smokeless Tobacco Use
Keywords: Tobacco use disorder
Tobacco cessation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-10-26
Enrollment: 270
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 will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

Detailed description: Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment

Eligibility criteria: Inclusion Criteria:

* are at least 18 years of age;
* report smokeless tobacco (ST) as their primary tobacco of use;
* have used ST daily for the past 6 months;
* are in general good health (determined by medical history and screening physical examination);
* have been provided with, understand, and have signed the informed consent.

Primary outcomes:
measure: Prolonged Smokeless Tobacco Abstinence at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Self-reported Point Prevalence All Tobacco Abstinence at 3 Months
timeFrame: 3 months
measure: Prolonged Smokeless Tobacco Abstinence at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Mayo Clinic
name: Jon O. Ebbert, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04740138: Development of DBT/Parent Training Group Intervention
Official title: Development of DBT/Parent Training Group Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Emotional Distress
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This treatment development study is aimed at developing and pilot testing a 24-week remotely delivered group intervention that integrates three evidence-based treatments: 1) Dialectical Behavior Therapy (DBT) Skills - targeting adult emotion dysregulation, 2) Parent Management Training (PMT) - targeting parenting behaviors linked to child behavioral dysregulation, and 3) Emotion Coaching (EC) - targeting parental emotion socialization practices linked to child emotion dysregulation.

The aims of the study are to:

1. Evaluate the feasibility of the intervention, specifically with respect to its acceptability and its implementation with 4 families in which a parent has elevated levels of emotion dysregulation and their child has elevated levels of emotion or behavioral dysregulation.
2. Examine change patterns in parent and child mental health and parenting quality using a Single Case Experimental Design (SCED) to evaluate both pre-post and weekly changes in these outcomes.


Eligibility criteria: Inclusion Criteria:

* parent must be 18+ years of age
* parent must have at least partial custody of a 3-6 year old child
* neither parent nor child may have any known developmental disability
* parent must be proficient in English
* parent must endorse elevated emotion dysregulation and report their child meets a cutoff for emotional and/or behavioral difficulties.
* parent must have access to the internet and Zoom software

Exclusion Criteria:

* parent with developmental disability
* psychotic disorder
* actively suicidal with an active plan

Primary outcomes:
measure: Change in parental emotion dysregulation
timeFrame: Baseline up to 24 weeks
measure: Change in child behavior
timeFrame: Baseline up to 24 weeks
measure: Change in parenting Quality
timeFrame: Baseline up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
References:
Clinical trial NCT01941238: Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection
Official title: Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi-dose Insulin Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Ramadan
Fasting
Diabetes
Type1
Insulin
Pump
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 142
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of our study is all patients with type1DM treated at three National Guard institutiuons in three different cities of Saudi Arabia (Riyadh, Alahsa, Dammam) with either insulin pump or MDI

Brief summary: Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there are extremely limited studies on the difference between insulin pump compared to MDI on the incidence of hypoglycemia and other acute complications during fasting Ramadan

The investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting Ramadan compared to MDI without deterioration in glycemic control. Results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1DM during Ramadan.


Eligibility criteria: Inclusion Criteria:

1. DM type 1
2. Age ≥14 years
3. Patients on insulin pump (more than 3 months)
4. Patients on MDI (glargine or detemir combined with aspart or lispro) regimen
5. Diagnosis of type 1 DM of more than 6 months.
6. Willing to do Self Monitoring Blood Sugar (SMBG)
7. Have no other contraindication to fast

Exclusion Criteria:

1. Patient with renal or hepatic impairment
2. Patient with diagnosed adrenal insufficiency
3. Pregnancy
4. Alcoholism
5. Any diagnosed psychiatric disease
6. Can not do SMBG

Primary outcomes:
measure: Incidence of hypoglycemia
timeFrame: 5 weeks
Secondary outcomes:
measure: Number of fasting days lost
timeFrame: 5 weeks
measure: Glycemic control
timeFrame: Two (2) months
measure: overnight hypoglycemia
timeFrame: 5 weeks
measure: Rate of acute complications
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: National Guards Hospital
Study officials:
References:
citation: Alamoudi R, Alsubaiee M, Alqarni A, Aljaser S, Saleh Y, Salam A, Eledrisi M. Attitudes and habits of patients with type 1 diabetes during fasting Ramadan. J Clin Transl Endocrinol. 2018 Sep 6;14:1-4. doi: 10.1016/j.jcte.2018.09.001. eCollection 2018 Dec.
Clinical trial NCT03602638: Effects of a Dipeptidyl Peptidase-4 Inhibitor Sitagliptininsulin on the Progression of Coronary Atherosclerosis in Patients With Type 2 Diabetes
Official title: Chinese PLA General Hospital Hainan Branch
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atherosclerosis Type 2 Diabetes Mellitus Dipeptidyl Peptidase-4 Inhibitor GLP-1
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on progression of coronary atherosclerosis in patients with type 2 diabetes.

Detailed description: This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on progression of coronary atherosclerosis in patients with type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18, \< 80 years old, with type 2 diabetes mellitus and coronary heart disease.

Exclusion Criteria:

* Allergy or hypersensitivity to any of the drug's components. Severe liver failure, moderate or severe kidney failure Malignant disease. Active infectious disease. Pregnancy or breastfeeding.

Primary outcomes:
measure: coronary calcification score
timeFrame: Changes from baseline in coronary calcification score at 18 months]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: