louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00455988: Developement of Questionnaire to Evaluate a Regularity of Lifestyle in Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Keywords: questionnaire developement
regularity
lifestyle
type 2 diabetes
Lead sponsor: Eulji University Hospital
Sponsor class: OTHER
First posted: 2007-04-04
Enrollment: 360
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: In order to manage of type 2 diabetic patients with irregular lifestyle, developement of an appropriate questionnaire to evaluate a regularity of lifestyle is necessary.

Detailed description: We have a plan to perform the seven day's records and the questionnaires which is necessary to type 2 diabetic patients for the initial step. Next, we will revise a questionnaire with professional advices for several times. Finally we will test a reliability with a final version as form of multisite based study and will confirm a questionnaire for a regularity of lifestyle in type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients

Exclusion Criteria:

* Type 1 diabetic patients, gestational DM patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eulji University Hospital
Study officials:
affiliation: Eulji University Hospital Diabetes Center
name: Kyung Wan Min, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00747188: The Impact of Problem-Based Learning (PBL) and Lecturing
Official title: The Impact of Problem-Based Learning (PBL) and Lecturing on the Behavior and Attitudes of Iranian Nursing Students: a Randomised Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Learning
Keywords: Problem-based learning (PBL)
lecture
nursing
education
none of students had any prior exposure to PBL
Lead sponsor: University of Tasmania
Sponsor class: OTHER
First posted: 2008-09-04
Sex: ALL
Minimum age (years): 19
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The present study aimed to compare the effect of education through problem-based learning (PBL) or lectures on behavior, attitude and learning of nursing students.

Detailed description: A total of 40 second-year nursing students participated: 20 students in the PBL group and 20 students in the traditional lecture (control) group. The students underwent a one-semester course using the two methods of education

Eligibility criteria: Inclusion Criteria:

* Students must not have been exposed to PBL

Exclusion Criteria:

* Biased and specific students

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Dehkordi AH, Heydarnejad MS. The impact of problem-based learning and lecturing on the behavior and attitudes of Iranian nursing students. A randomised controlled trial. Dan Med Bull. 2008 Nov;55(4):224-6.
Clinical trial NCT03200678: WEakness and Atrophy: isoKinetic With Surface Electromyography Assessment in ACL Surgery
Official title: Motor Unit Recruitment Study With Fatigue Testing: 9 Months Following up After Anterior Cruciate Ligament Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Muscle Weakness
Keywords: knee muscle
strength
fatigue
MRI
ACL
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: An assessment of the effect of surgical anterior cruciate ligament (ACL) on thigh muscles is critical to the improvement of knee rehabilitation and preservation. However, if a large number of studies had rated surgical technics, giving high results level for ACL reconstruction (ACLR), muscle recovery is still conditioning functional success. Furthermore there is no consensus about criteria in return to sport.

The aim of this exploratory study is to quantify the mechanisms of neuromuscular adaptation of muscle thigh after ACL surgery.

Detailed description: The aim of this study is to assess the qualitative and quantitative variations of the strength, work and fatigue of the thigh muscles after ACL surgery. The reference is the preoperative assessment (V1), the variation is measured on V2 (measurements at 3 months) and V3 (measures at 9 months). Each patient is his own control. In addition, a control group of healthy subjects is used to determine level of significance of each parameter.

Eligibility criteria: Inclusion criteria:

ACLR group :

* men or woman
* 18 to 45 years old
* No injuries sequels on contralateral limb
* No contraindication to magnetic resonance imaging

Control group :

* men or woman
* 18 to 45 years old
* No limb injuries sequels
* No contraindication to magnetic resonance imaging

Exclusion criteria:

* age less than 18 years
* limb injuries sequels
* contraindication to magnetic resonance imaging

Primary outcomes:
measure: muscle torque
timeFrame: Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2), measures at 9 months (V3)
Secondary outcomes:
measure: muscle work
timeFrame: Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2) and measures at 9 months (V3)
Other outcomes:
Locations:
city: Brest
country: France
facility: Hôpital d'Instruction des Armées Clermont-Tonnerre
Study officials:
affiliation: Direction Centrale du Service de Santé des Armées
name: Dominique Tardy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04898478: Intervention Development and Pilot Study to Prevent Untreated Native Hawaiian and Pacific Islander Opioid Use Disorder
Official title: Intervention Development and Pilot Study to Prevent Untreated Native Hawaiian and Pacific Islander Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Opioid-use Disorder
Lead sponsor: University of California, Riverside
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will design and pilot/feasibility test a culturally grounded intervention to increase the treatment seeking of Pacific Islanders with opioid use disorders in formal services.

Detailed description: For the clinical trial arm of this pilot/feasibility study, the investigators will conduct a pilot/feasibility test of our conceptual model of culturally grounded intervention components with 20 Pacific Islander adults with experience with opioid use disorders, then conduct 2 focus groups per site to finalize the components and items for larger R01 pilot and randomized wait-list controlled testing.

Eligibility criteria: Inclusion Criteria:

* Of Pacific Islander/Native Hawaiian or part-Pacific Islander/Native Hawaiian heritage.
* Live in Utah or Hawaii.
* For all lay Pacific Islander adult participants: must be over 18 years of age.
* Fluent (oral and reading) in English or Native Hawaiian.

For target Pacific Islander participants with OUDs, additional inclusion criteria is:

- Presence of active OUD, as screened via 8-item Rapid Opioid Dependence Scale.

Exclusion Criteria:

* Do not meet inclusion criteria,
* Are unwilling to participate,
* Fails to provide or retracts consent,
* Reside outside the target communities of Utah or Hawaii

Primary outcomes:
measure: Pacific Islander Knowledge Scale about Opioid Use Disorders and Treatment
timeFrame: Up to 12 months
Secondary outcomes:
measure: Pacific Islander Attitude Scale about Opioid Use Disorders and Treatment
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Riverside
country: United States
facility: UC Riverside
state: California
Study officials:
References:
Clinical trial NCT05623878: 68Ga-labeled NY108 PET Imaging in Patients
Official title: 68Ga-labeled NY108 PET Imaging in Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Prostatic Cancer
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY108 (68Ga-NY108) PET Imaging in patients.


Eligibility criteria: Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Age 18-75, male;
3. Patients diagnosed with prostatic cancer confirmed by histopathology or cytology;
4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
5. Patients with biopsy-proven PSMA positive;
6. ECOG score 0\~3; Life expectancy of at least 3 months;

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with allergies or allergies to any component of the imaging agent or antibody;
4. Patients who cannot perform PET/CT imaging scan;
5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
6. Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation;
7. Uncontrolled hypertension;
8. Syphilis, HBV, HCV, or HIV positive subjects;
9. Male subjects of reproductive age cannot take effective contraceptive measures;
10. Patients with a history of mental illness or related conditions;
11. Other subjects considered unsuitable by researchers.

Primary outcomes:
measure: Evaluation of tissue distribution of 68Ga-Anti-PSMA mAbs(NY108)
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 1 year
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Jiangnan University
name: Chunjing Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03577678: New Prosthesis for Comminuted Fracture of Lateral Half of Clavicle
Official title: Comminuted Lateral Half Fracture of Clavicle is Most Common and at This Case Report Study the Investigators Introduce a New Prophesies for This Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Fracture
Bone Lesion
Clavicle Fracture
Keywords: Comminuted lateral clavicle fracture , New prosthesis,
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 1
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Surgery was made to fix the new prosthesis
Primary purpose: OTHER

Brief summary: This study to evaluate the efficacy of new prosthesis in treatment of comminuted fracture of lateral half of the clavicle in adult female.

Detailed description: . Lateral clavicle fracture lead to sever pain and affect on shoulder movement . This prosthesis will compensate the lost part of the clavicle due to fracture to return the patient to the daily living activity without pain.

This prosthesis will reconstruct the missed part of the clavicle.

Eligibility criteria: Inclusion Criteria:

* Female has right lateral part comminuted fracture clavicle .

Exclusion Criteria:

* Male patient
* Cancer bone patient.
* Pregnant
* Left lateral part comminuted fracture clavicle

Primary outcomes:
measure: CT scan
timeFrame: 1 Day
Secondary outcomes:
measure: CT scan
timeFrame: 6 month
measure: Pain intensity measurements: Visual analogue scale
timeFrame: 6 month
measure: American shoulder and elbow surgeons score Special Score for shoulder pain and function.
timeFrame: 6 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alkasr alini hospital
Study officials:
name: Sahar A Abdalbary, ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06214078: Preliminary Clinical Study of NMN Intervention in Mild Ulcerative Colitis
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial of Nicotinamide Mononucleotide in the Treatment of Mild Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis Chronic Mild
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the safety and efficacy of nicotinamide mononucleotide (NMN) and placebo in patients with mild ulcerative colitis (UC). The main question it aims to answer is Whether NMN can alleviate the intestinal pathology of UC patients, so as to play a role in UC treatment or adjuvant therapy.

Participants will be randomized into two groups, an NMN group or a placebo group. Patients in the NMN group were treated with NMN intervention for 8 weeks. The placebo group received a placebo intervention for 8 weeks.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old, ≤75 years old;
2. Clinical diagnosis of mild active UC patients, the diagnosis standard reference inflammatory bowel disease diagnosis and treatment of the consensus of opinion 2018.
3. Agreed to participate in this study, and sign the informed consent.

Exclusion Criteria:

1. Patients with ALT or AST more than 2 times the upper limit of normal, TBIL more than 2 times the upper limit of normal;
2. The creatinine clearance patients less than 60 ml/min.
3. The intestines or other parts have severely active infection patients need to use antibiotics or antiviral drugs;
4. Crohn's disease and intestinal tuberculosis and other chronic intestinal infectious disease, intestinal malignant tumor patients;
5. Pregnancy and lactation women;
6. People with diabetes or screening period more than 7.0 tendency for fasting glucose/L or glycosylated hemoglobin exceed 6.5%;
7. With serious mental illness, such as drugs and alcohol can't cooperate with the patients;
8. Participated in any other clinical investigator within 1 month before the screening period;
9. The researchers determine any other disease or condition is not suitable for patients participate in the study.

Primary outcomes:
measure: Clinical response rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Biomarker target attainment rate
timeFrame: 8 weeks
measure: clinical remission rate
timeFrame: 8 weeks
measure: Endoscopic remission rate
timeFrame: 8 weeks
measure: Histologic remission rate after 8 weeks of intervention
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: Xiaoyan Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01176578: Exercise Endothelial Progenitor Cells (EPCs) and Type 2 Diabetes
Official title: Exercise Training, CACs, and Vascular Function in Older Veterans With IGT (Impaired Glucose Tolerance)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Baltimore VA Medical Center
Sponsor class: FED
Collaborators: name: University of Maryland, Baltimore
First posted: 2010-08-06
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The discovery of the role of endothelial progenitor cells (EPCs) and their involvement in the cardiovascular complications of type 2 diabetes (T2DM) would quickly have a significant impact on the millions of Americans who have T2DM. This project is designed to 1) determine the mechanisms underlying EPC dysfunction in older, sedentary adults with T2DM compared those with normal glucose metabolism and impaired glucose metabolism, and 2) determine if aerobic exercise training is an efficacious therapy for EPC dysfunction in T2DM, and whether improvement in EPC number and function translates to improved endothelial function, increased capillarization, and improved glucose metabolism in T2DM.


Eligibility criteria: Inclusion Criteria:

* Age 50-80
* Non-smoker
* If woman, postmenopausal \>1 year

Exclusion Criteria:

* History of heart disease or stroke
* Cancer
* Poorly controlled hypertension or dyslipidemia
* Kidney or Liver diseases

Primary outcomes:
measure: Endothelial progenitor cell number
timeFrame: Baseline
measure: Endothelial progenitor cell number
timeFrame: 6-month
measure: Skeletal muscle capillarization
timeFrame: Baseline
measure: Skeletal muscle capillarization
timeFrame: 6-month
Secondary outcomes:
measure: Cardiorespiratory Fitness
timeFrame: Baseline
measure: Cardiorespiratory Fitness
timeFrame: 6-month
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT03542578: Diagnosis of Fatty Liver with Outpatient Ultrasound
Official title: Diagnosis of Fatty Liver with Outpatient Ultrasound
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Steatoses
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting outpatient clinic will be evaluated

Brief summary: This study will evaluate whether ultrasound performed during outpatient visit is effective in early diagnosis of fatty liver.

Detailed description: All patients presenting to dedicated hepatology clinic with concern for fatty liver will be evaluated by ultrasound. This will be compared with standard imaging performed for this condition. The data will be compared for effectiveness of outpatient evaluation with dedicated imaging currently practiced

Eligibility criteria: Inclusion Criteria:

* all patients presenting to dedicated clinic

Exclusion Criteria:

* presence of ascites, inability to give consent to have study

Primary outcomes:
measure: Outpatient ultrasound in diagnosis of fatty liver diagnosis
timeFrame: Bedside evaluation performed after consent and compared with radiological imaging perfomed within 3 months of this bedside evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Achuthan Sourianarayanane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00061178: Efficacy and Safety Study of rhuMAb VEGF to Treat Metastatic Renal Cell Carcinoma
Official title: Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy & Safety of rhuMAb VEGF in Previously Treated Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Renal Cell Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2003-05-23
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: The purpose of this study is to determine whether rhuMAb VEGF (Bevacizumab) is safe and effective for the treatment of renal cell cancer when other treatments have failed.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Histologically confirmed, metastatic renal cell cancer (RCC) of clear cell histology
* Clinical or radiographic evidence of disease progression (as assessed by the investigator and reviewed by the Sponsor) during or after completion of one, and only one, cytokine-based regimen for metastatic disease
* At least 21 days since any prior therapy for RCC
* Prior nephrectomy
* Use of an acceptable means of contraception (potentially fertile men and women)
* ECOG performance status of 0 or 1
* Life expectancy \>= 3 months
* Age 18 years or older

Exclusion Criteria:

* RCC of papillary or collecting-duct type
* More than one nonsurgical therapy for metastatic RCC (note that medroxyprogesterone acetate not used for physiologic replacement or birth control is considered a therapy for RCC for the purposes of this study)
* Prior treatment with thalidomide
* Radiotherapy within 14 days of Day 0
* Current, recent (within 21 days of Day 0), or planned participation in an experimental drug study
* Pregnant or breast-feeding subjects
* Any of the following screening clinical laboratory values: 24-hour urine collection with \>= 1 g of protein; Serum creatinine \> 2.0 mg/dL; Absolute neutrophil count (ANC) \<500/mL; Platelet count \<75,000/mL; INR \>= 1.5; Total bilirubin \> 2.0 mg/dL; AST or ALT \> 5 x the upper limit of normal (ULN) for subjects with documented liver metastases or \> 2.5 x the ULN for subjects without evidence of liver metastases; Hemoglobin \< 9 gm/dL (may be transfused or receive epoetin alfa \[e.g., Epogen\] to maintain or exceed this level)
* Other invasive malignancies within 5 years of randomization (other than squamous or basal cell carcinoma of the skin)
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
* Inability to comply with study and/or follow-up procedures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: