louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02121366: EUS-guided Ethanol Ablation of an Insulinoma
Official title: Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulinoma
Keywords: Endoscopic Ultrasound-Guided Fine Needle Aspiration
Insulinoma
Ethanol
Ablation Techniques
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol ablation of an insulinoma.

Detailed description: As the major insulinomas are functioning islet cell tumors, surgical resection is currently first-line therapy for or treatment of insulinomas. However, the surgical resection of pancreatic neoplasm is conditional for specific patients and may be associated with substantial life-threatening complications. Several studies declared that endoscopic ultrasound (EUS)-guided lavage may offer an alternative to surgical resection of insulinomas. Nevertheless, their sample sizes were small and conclusions were built based on short-term outcomes. In addition, the amount of ethanol administrated for different types of insulinomas were inconsistent among those studies.

The present study aims to evaluate the safety, feasibility and efficacy of EUS-guided ethanol ablation therapy of insulinomas. We will use cytopathology and immunohistochemistry in combination with EUS-FNA for diagnosis of insulinoma. After EUS-guided ethanol ablation therapy, the safety and efficacy will be assessed at the baseline and different time points during follow-up by physicians blinded to the treatment or control status.

Eligibility criteria: Inclusion Criteria:

1. Adults: at least 18 years.
2. Patients with insulinomas which are evaluated by histopathology .
3. patients who have signed a written consent form.

Exclusion Criteria:

1. Patients whose condition is not suitable for the endoscopic procedure.
2. Patients who have blood coagulation dysfunction.
3. Patients who have mental disorders.
4. Patients who have mild or severe cardiorespiratory insufficiency.
5. Patients who have hypertension and could not be controlled to safe level.
6. Pregnant and lactating women.
7. Patients whose conditions are not suitable for the present study.

Primary outcomes:
measure: Efficacy of EUS-guided ethanol ablation
timeFrame: 1 to 12 month
measure: Safety of EUS-guided ethanol ablation
timeFrame: 1 to 12 month
Secondary outcomes:
measure: Technical feasibility
timeFrame: during the procedure of treatment
Other outcomes:
Locations:
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Shanyu Qin, MD. Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04915066: Study of Insulin Pump Discontinuation in Adults With Diabetes
Official title: Probability and Factors Associated With Early Discontinuation of Insulin Pump Therapy in Adults With Diabetes at the Center Hospitalier Sud Francilien
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus, type 1
Diabetes mellitus, type 2
Insulin Infusion Systems
Patient Education
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 313
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample of patients from the diabetes department of a public hospital in France (Corbeil-Essonnes).

Brief summary: The purpose of this study is to determine the rate of insulin pump discontinuation 18 months after initiation in patients with diabetes, and to determine factors associated with this discontinuation.

Detailed description: Insulin pump discontinuation has been mostly studied in children and young adults living with diabetes, and rarely with a time-to-event analysis. We aim to evaluate the rate of insulin pump discontinuation after 18 months from initiation and factors associated with it in adults with diabetes.

Knowing these factors would allow better support for patients in difficulty.

Eligibility criteria: Inclusion Criteria:

All patients (adults and adolescents) with diabetes and an insulin pump initiation from 1 January 2015 to 30 June 2018 in the diabetes department of the Centre hospitalier sud francilien.

Exclusion Criteria:

* Pregnant women (or women planning pregnancy in the short term) with an insulin pump initiation from 1 January 2015 to 30 June 2018
* Patients hospitalized for an insulin pump replacement or change between 1 January 2015 and 30 June 2018.
* Patients with a history of insulin pump initiation within a period of less than 6 months before a new pump start between 1 January 2015 and 30 June 2018.

Primary outcomes:
measure: Permanent discontinuation of insulin pump use.
timeFrame: at 18 months
Secondary outcomes:
measure: Age
timeFrame: at day 0
measure: Sex
timeFrame: at day 0
measure: type of diabete
timeFrame: at day 0
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
References:
Clinical trial NCT00418366: A Study on the Effect of Kidney Disease on a Diabetes Medication (0431-008)
Official title: An Open- Label, 2 Part Study to Investigate the Pharmacokinetics, Safety, and Tolerability of MK0431(Sitagliptin Phosphate) in Patients With Varying Degrees of Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency
Hemodialysis
Keywords: Mild, moderate, severe renal insufficiency
End stage renal disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication


Eligibility criteria: Inclusion Criteria :

* Male and non-pregnant females with a clinical diagnosis of renal insufficiency with mild, moderate, severe or end stage renal disease on hemodialysis
* A body mass index of less than 40 kg per meter squared (body weight in kg divided by height in meters squared)
* Smokes less than 10 cigarettes/day

Exclusion Criteria :

* Patients with uncontrolled diabetes or uncontrolled congestive heart failure
* Patient has abnormal prestudy laboratory measurements including serum potassium or white blood counts
* Patient has systolic blood pressure below 100 mm Hg or above 180 mm Hg
* Patient has diastolic blood pressure less than 50 mm Hg systolic or above 100 mmHg

Primary outcomes:
measure: Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers
Secondary outcomes:
measure: Safety and tolerability in patients with renal insufficiency
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bergman AJ, Cote J, Yi B, Marbury T, Swan SK, Smith W, Gottesdiener K, Wagner J, Herman GA. Effect of renal insufficiency on the pharmacokinetics of sitagliptin, a dipeptidyl peptidase-4 inhibitor. Diabetes Care. 2007 Jul;30(7):1862-4. doi: 10.2337/dc06-2545. Epub 2007 Apr 27. No abstract available.
Clinical trial NCT04995666: Hearing Aid Quality and Reliability Study
Official title: Hearing Aid Quality Check and Reliability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2021-08-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.


Eligibility criteria: Inclusion Criteria:

* Adults with mild to moderate severe sensorineural hearing loss
* Adults who were able to incorporate some type of physical activity into their day (i.e walking, excercise, gardening, etc.)

Exclusion Criteria:

* Unable or unwilling to wear study devices during a home trial
* Unable or unwilling to come to lab for study visits

Primary outcomes:
measure: Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1
timeFrame: Day 1 of study
measure: Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45
timeFrame: Day 45 of study
measure: Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90
timeFrame: Day 90 of study
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Sonova
state: Illinois
Study officials:
References:
Clinical trial NCT06634966: Segmentectomy for Solid-dominant Lung Cancer
Official title: Segmentectomy for Solid-dominant GGO-featured Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Segmentectomy
Lung Adenocarcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1025. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for solid-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are:

* The 5-year disease-free survival of patients having solid-dominant invasive lung cancer with size of 2-3cm;
* The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.


Eligibility criteria: Inclusion Criteria:

* Patients who sign the informed consent form and are willing to complete the study according to the plan;
* Aged from 18 to 80 years old;
* ECOG equals 0 or 1;
* Not receiving lung cancer surgery before;
* Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively;
* Ground glass-dominant lung nodules
* Consolidation-to-tumor ratio (CTR) ranges from 0.5 to 1, and tumor size ranges from 2 to 3cm;
* cN0 without distant metastasis;
* Tumors could be completely resected assed by surgeons;
* Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria:

* CTR is not 0.5-1, or size is not 2-3cm;
* Tumors could not be completely resected assed by surgeons;
* Not lung adenocarcinoma diagnosed cytologically or pathologically;
* Receiving lung cancer surgery before;
* Receiving radiotherapy or chemotherapy.

Primary outcomes:
measure: 5-year disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Lung function test
timeFrame: Half year and one year after surgical resection
measure: 5-year overall survival
timeFrame: 5 years
measure: The site of tumor recurrence and metastasis
timeFrame: From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.
measure: Segmentectomy completion rate
timeFrame: From the beginning of the surgery to the end of the surgery.
measure: Radical segmentectomy (R0 resection) completion rate
timeFrame: From surgery to the release of the final pathology report, an average of two weeks.
measure: Surgery-related complications
timeFrame: From surgery to patient discharge or 30 days after surgery.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Haiquan Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02633566: Clinical Trial of the Effect of Functional Orthoses in Children With Flat Feet
Official title: Randomized Clinical Trial of the Effect of Functional Orthoses on the Joint Position of the Hindfoot in Children With Flat Feet After a Year of Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flexible Flatfoot
Keywords: Flatfoot
orthoses
children
Lead sponsor: Fresno, Raquel Lopez, M.D.
Sponsor class: INDIV
First posted: 2015-12-17
Enrollment: 61
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficay of functional plantar orthoses on flatfoot in children.

Detailed description: There's a considerable controversy regarding the effectiveness of plantar orthoses in the treatment of flexible flat foot, despite being the most widely used treatment. Several studies tried to investigate the correction of the deformity using plantar orthoses, but there are few studies with a control group of people, not enough to compare the effectiveness of the treatment.

A randomized, double-blind, parallel design clinical trial was conducted with two study groups. The sample consisted of 61 children, aged 3 and 4 years old, who were randomly assigned to each study group. One group (intervention group) received treatment with functional plantar orthotics, and the other group (control group) received treatment with placebo-type plantar orthotics, to use as a reference or comparison. Both groups were followed for a one-year period. Before delivering the treatment, all subjects underwent dorsoplantar radiography, repeated at the end of the treatment (after one year). Differences in the talus-calcaneus, tibionavicular and talus-first metatarsal angles were compared, pre and post-treatment of both study groups. Test analysis of covariance (ANCOVA) was performed as a statistical test.

Eligibility criteria: Inclusion Criteria:

* Flexible flatfoot

Exclusion Criteria:

* Congenital Vertical talus
* Tarsal coalition
* Neuromuscular disease
* Ligamentous laxity
* Previous history of surgery on lower limb
* Previous orthotic treatment

Primary outcomes:
measure: X-ray measurements of the angles: talus-calcaneus, talus-navicular and talus-first metatarsal angle.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Javier Pascual Huerta, PhD
role: STUDY_DIRECTOR
References:
citation: Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.
citation: Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.
Clinical trial NCT05539066: AI Health Assistant and Type 2 Diabetes
Official title: Application of AI Health Assistant in Out of Hospital Management of Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Type2 Diabetes Mellitus
Keywords: Type 2 Diabetes
AI health assistant
Off hospital management
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The developed health assistant has the functions of intelligent analysis of health data inside and outside the hospital, health reminder, etc. The advantages of AI health assistant management group compared with conventional management group in terms of comprehensive compliance rate, metabolic index level, hypoglycemia incidence rate was further studied.

Detailed description: 1. The investigators have developed an AI health assistant suitable for diabetes patients, which has the functions of automatically uploading blood pressure, blood glucose data, intelligent reminder, automatic analysis of reports inside and outside the hospital, intelligent question and answer, etc. it is simple to operate, highly interactive, and maximizes the management level of diabetes patients outside the hospital.
2. Through AI personal health assistant, 196 diabetes patients were managed to further improving the comprehensive compliance rate of metabolic indicators such as blood glucose and blood pressure of diabetes patients, improving the patients' self-management ability.

Eligibility criteria: Inclusion Criteria:

The diagnostic criteria of T2DM patients are the diagnostic criteria of the 2017 China guidelines for the prevention and treatment of type 2 diabetes HbA1c 7.5-13% Age: 18-65y BMI 18.5-30kg/m2 The course of disease is less than 5 years Have good cognitive ability and can correctly use health assistants

Exclusion Criteria:

Acute complications of diabetes (diabetes ketosis, etc.) Diabetes complicating pregnancy or preparing for pregnancy HbA1c \< 7.5% or \> 13% Age \< 18y or age \> 65y Pre pregnancy BMI \< 18.5 or \> 30kg / m2 Severe liver and kidney dysfunction (ALT greater than 2.5 times the upper limit of normal, EGFR less than 45 ml / min / 1.73m2) Using drugs that may affect blood glucose are being used (including steroids, hydroxyprogesterone hexanoate, anti AIDS drugs, etc.)

Primary outcomes:
measure: HbA1c compliance rate
timeFrame: 6 months
measure: Blood pressure compliance rate
timeFrame: 6 months
measure: Compliance rate of total cholesterol
timeFrame: 6 months
measure: Compliance rate of BMI (Body Mass Index)
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of hypoglycemia
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Yufan Wang, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01033266: Effect of Nasal CPAP on Cardiopulmonary Exercise Testing in Patients With Overlap Syndrome
Official title: Effect of Continuous Positive Airway Pressure (CPAP) and Cardiopulmonary Exercise Testing(CPET) in Patient With Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with OSA and COPD will perform CPET before and after use of CPAP.

Brief summary: Nasal CPAP will improve cardiopulmonary exercise test (CPET) performance in patients with overlap syndrome(COPD and OSA). Nasal CPAP is proven to improve cardiopulmonary exercise testing in patients with OSA. The investigators hypothesis is that patients with overlap syndrome will have a greater improvement in their cardiopulmonary exercise testing besides a possible improvement in their lung function test and airway resistance.

Detailed description: Patients presenting to the Oklahoma City VA sleep clinic with obstructive sleep apnea syndrome and a desire to initiate CPAP treatment will be included if they have overlap syndrome. Patients will undergo a spirometry and CPET before being started on CPAP as part of standard clinical care. The CPET will be repeated after 8-12 weeks of CPAP use. Patients will be excluded if they have any contraindication to mild exercise or they cannot perform an exercise test due to limited mobility.

Eligibility criteria: Inclusion Criteria:

* Obstructive sleep apnea (OSA)
* COPD

Exclusion Criteria:

* Inability to perform exercise test due to musculoskeletal limitation
* Cardiac condition preventing patient from mild exercise
* Continuous oxygen supplement

Primary outcomes:
measure: Efficacy of nasal CPAP on CPET performance in patients with overlap syndrome
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: VA Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Gary Kinasewitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Houssein Youness, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05385666: Collaborative Mental Health Care Model: an Evaluation of the Implementation of a Pilot in Four Primary Care Organization
Official title: Collaborative Mental Health Care Model: an Evaluation of the Implementation of a Pilot in Four Health Homes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Disorder
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Frequent mental disorders (anxiety or mood disorders), an important part of primary care patient care, remain insufficiently detected and treated. Improving their care requires better coordination between general practice and specialized care. The collaborative care model developed in Washington State with the introduction of a care manager is recognized. About 100 randomized controlled trials have established its effectiveness and efficiency, in terms of improving the progression of disorders (remission rate), adherence, quality of life, professional and patient satisfaction, and cost savings. However, the possibility of implementation of these validated care remains to be explored. A dozen collaborative care implementation studies exist, all conducted in the USA and not having considered all the dimensions of the indicators of penetration, acceptability/adoption, feasibility, fidelity and cost. A first implementation in France is implemented since September 2021 in the Yvelines department on four sites of different size, organization and environments: the multi-professional health centers (MSP) of Mureaux and Celle St Cloud, the Chevreuse medical house and MG in isolated practice in Versailles.

The main objective of the research project is to evaluate the first implementation in France of collaborative care for frequent psychic disorders according to the indicators of penetration, acceptability/adoption, fidelity, relevance, feasibility and cost.


Eligibility criteria: Inclusion Criteria:

* healthcare professionals involved in the collaborative care system
* patients who have been referred for collaborative care by their family physician

Exclusion Criteria:

* patient refusal to participate in research
* adults protected by law

Primary outcomes:
measure: to evaluate the first implementation in France of collaborative care for frequent psychic disorders
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chevreuse
country: France
facility: Maison de Santé Pluridisciplinaire
city: les Mureaux
country: France
facility: Maison de Santé Pluridisciplinaire
city: Versailles
country: France
facility: Cabinet Médical Versailles
city: Versailles
country: France
facility: cabinet médical Versailles
city: Versailles
country: France
facility: Cabinet Médical Versailles
Study officials:
References: