louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01071785: Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)
Official title: Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Albuminuria
Keywords: Metabolic Syndrome
diet
fiber
Serum lipids
Albuminuria
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2010-02-19
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Metabolic Syndrome (MS) is an clinical condition with high cardiovascular risk. More than 80% of DM patients had MS. Dietary factors can be associated to both, DM and MS. Therefore the aim of this study is to evaluate the effects of add soluble fiber (goma-guar) in the usual diet of type 2 DM with MS and compare this intervention with an usual diet without this supplement.

Detailed description: The aim of this study was to evaluate the effect of soluble fiber (guar gum) on the MS components (International Diabetes Federation-2005 and WHO): blood pressure, plasma glucose, triglycerides, HDL, central obesity (waist, BMI),and albuminuria. Secondary objectives are: effect of guar gum on serum fatty acids, , PCR, endothelin 1, and fibrinogen. Primary outcomes were alterations on MS components.

Forty-four type 2 diabetic outpatients were included in a randomized clinical trial: treatment 1- guar gum (10g/day) + usual diet; treatment 2- usual diet. The duration of each treatment was six weeks. Three days weight diet records with concurrent 24h urinary collections (protein intake estimative), clinical and laboratory evaluation were performed at baseline and after 4 and 6 weeks. Serum fatty acids were measured in total triglycerides fractions by gas chromatography.

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes
* Using metformin and/or Insulin

Exclusion Criteria:

* serum triglycerides \> 400 mg/dl
* serum creatinine \> 2 mg/dl
* gastrointestinal malabsorption

Primary outcomes:
measure: Changes on the components of metabolic syndrome (according to IDF and WHO criteria): blood pressure, waist, body mass index (BMI), triglycerides, high-density lipoprotein (HDL) cholesterol, glucose values (HBA1c) and urinary albumin excretion.
timeFrame: 4 and 6 weeks
Secondary outcomes:
measure: changes on serum fatty acids and serum cholesterol
timeFrame: 4 and 6 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: HCPA
state: RS
Study officials:
affiliation: HCPA
name: Mirela J Azevedo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HCPA
name: Jorge L Gross, MD
role: STUDY_DIRECTOR
affiliation: HCPA
name: Valesca Dall'Alba, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05866185: Improving Adherence to Homework During Therapy
Official title: Improving Adherence to Evidence-Based Practice Using an Innovative and Easy-to-Use Health IT Solution
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Depression/Anxiety
Keywords: mhealth
mental health
adult mental health
homework
health technology
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-05-19
Enrollment: 100
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 expand Adhere.ly- a simple, HIPAA-compliant, web-based platform to help therapists engage clients in practicing therapeutic skills between sessions (homework) during mental health treatment by conducting a trial comparing standard therapy to therapy enhanced with Adhere.ly.


Eligibility criteria: Inclusion Criteria:

Providers:

* English-speaking
* Mental health providers who have obtained at least a master's degree in social work, counseling, clinical psychology, or related field
* Carry active mental health treatment caseloads in the U.S.
* Have a laptop, tablet, or smartphone with internet access

Clients:

* English-speaking
* Treatment-seeking adults ≥18 year
* Clinically elevated anxiety and depression as indicated by a score ≥10 on the GAD-7 and/or PHQ-8
* Have a laptop, tablet, or smartphone with internet access

Exclusion Criteria:

Client with self-reported:

* Active psychotic symptoms (e.g., hallucinations, delusions)
* Significant cognitive disability, developmental delays, or pervasive developmental disorder.

Primary outcomes:
measure: Generalized Anxiety Disorder-7 (Gad-7)
timeFrame: Baseline
measure: Generalized Anxiety Disorder-7 (Gad-7)
timeFrame: 3-Months Post-Baseline
measure: Patient Health Questionnaire-8 (Phq-8)
timeFrame: Baseline
measure: Patient Health Questionnaire-8 (Phq-8)
timeFrame: 3-Months Post-Baseline
Secondary outcomes:
measure: Health-Related Quality of Life (CDC HRQOL-14)
timeFrame: Baseline
measure: Health-Related Quality of Life (CDC HRQOL-14)
timeFrame: 3-Months Post-Baseline
measure: Working Alliance Inventory - Short Revised - Client Version (Wai-sr)
timeFrame: 3-Months Post-Baseline
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 3-Months Post-Baseline
measure: Homework Rating Scale II (HRS II)
timeFrame: Weekly between Baseline and 3-Months Post-Baseline
measure: Homework Adherence And Competence Scale (Haacs)
timeFrame: Weekly between Baseline and 3-Months Post-Baseline
measure: Assessment of Core CBT Skills (ACCS)
timeFrame: Weekly between Baseline and 3-Months Post-Baseline
measure: Attitudes Toward Homework Questionnaire (ATHQ)
timeFrame: Baseline
measure: Attitudes Toward Homework Questionnaire (ATHQ)
timeFrame: 3-Months Post-Baseline
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
References:
Clinical trial NCT00900185: Study of a Polymorphism in Patients With Prostate Cancer
Official title: Retrospective Analysis of Endostatin Genotype in Prostate Cancer Patients to Assess the Association of a Single Nucleotide Polymorphism (D104N) in Endostatin and Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-12
Enrollment: 750
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: RATIONALE: Studying samples of blood from patients with cancer and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA.

PURPOSE: This laboratory study is looking at blood samples from patients with prostate cancer and from healthy participants to identify a polymorphism that may help in the study of prostate cancer.

Detailed description: OBJECTIVES:

Primary

* Determine the incidence of the D104N COL18A1 polymorphism in patients with prostate cancer.

Secondary

* Determine the incidence of this polymorphism in African-American patients with prostate cancer.

OUTLINE: This is a retrospective, multicenter study.

DNA is extracted from preexisting serum samples and polymerase chain reaction is performed to determine the genotype pattern.

PROJECTED ACCRUAL: A total of 500 patients and 250 healthy participants will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of prostate cancer OR healthy participant
* Patient enrolled on an IRB-approved clinical trial at the National Cancer Institute or Northwestern University, including, but not limited to, any of the following:

  * NCI-99-C-0052
  * NCI-95-C-0178
  * NCI-00-C-003
  * NCI-00-C-0080

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Frequency of D104N COL18A1 polymorphism in patients with prostate cancer and in healthy participants
Secondary outcomes:
measure: Frequency of D104N COL18A1 polymorphism in African-American patients with prostate cancer and in healthy participants
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute (NCI)
name: William D. Figg, PharmD
role: STUDY_CHAIR
References:
citation: Macpherson GR, Singh AS, Bennett CL, Venzon DJ, Liewehr DJ, Franks ME, Dahut WL, Kantoff PW, Price DK, Figg WD. Genotyping and functional analysis of the D104N variant of human endostatin. Cancer Biol Ther. 2004 Dec;3(12):1298-303. doi: 10.4161/cbt.3.12.1453. Epub 2004 Dec 16.
citation: Price DK, Macpherson GR, Dahut W, et al.: A mutation in COL18A1 and the association with prostate cancer. [Abstract] American Association for Cancer Research: 94th Annual Meeting, 11-14th July 2003, Washington, D.C. 44: A-4054, 810, 2003.
Clinical trial NCT03467685: Variable Perception of Cutaneous Stimulation
Official title: Determining the Variable Factors in Cutaneous Perception of Vibratory Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Anesthesia, Local
Dermatology/Skin - Other
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will be randomly assigned into one of two groups:

Group 1: Vibratory anesthetic device (VAD) is in the OFF mode Group 2: VAD is in the ON mode

We will use a random number generator to place patients into one of the two groups.
Primary purpose: PREVENTION

Brief summary: Perception of cutaneous sensory stimulation shows a large range of variability across multiple populations. Understanding this variability is critical to medical practice as interpretation of discomfort and pain is critical to diagnosis and treatment. Further, procedural medicine involves inflicting pain on patients in the form of injection of local anesthetic. Our protocol aims to determine how patients differentially interpret the non-noxious stimulation of vibration and the differences in perceiving anesthestic injection after the vibratory stimulus. We will explore how this ranges across all patients treated in a dermatological surgery out-patient setting. The goal is to identify which variables, such as age, gender, medical history, influence how sensation is interpreted.


Eligibility criteria: Inclusion Criteria:

* All patients

Exclusion Criteria:

* Patients less than 18 years of age

Primary outcomes:
measure: Numeric Rating Score
timeFrame: Within 5 seconds of injection
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Falk Medical Clinic
state: Pennsylvania
Study officials:
References:
citation: Kazi R, Govas P, Slaugenhaupt RM, Carroll BT. Differential Analgesia From Vibratory Stimulation During Local Injection of Anesthetic: A Randomized Clinical Trial. Dermatol Surg. 2020 Oct;46(10):1286-1293. doi: 10.1097/DSS.0000000000002314.
citation: Govas P, Kazi R, Slaugenhaupt RM, Carroll BT. Effect of a Vibratory Anesthetic Device on Pain Anticipation and Subsequent Pain Perception Among Patients Undergoing Cutaneous Cancer Removal Surgery: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2019 Dec 1;21(6):480-486. doi: 10.1001/jamafacial.2019.0733.
Clinical trial NCT03666585: Comparison of the Accuracy in Rehabilitation Exercise Between Mobile Application Actuated Rehabilitation Exercise Guidance and Routine Rehabilitation Exercise Guidance for the Primary Osteoarthritis Knee Patients
Official title: Comparison of the Accuracy in Rehabilitation Exercise Between Mobile Application Actuated Rehabilitation Exercise Guidance and Routine Rehabilitation Exercise Guidance for the Primary Osteoarthritis Knee Patients : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobile Application Actuated Rehabilitation Exercise Guidance
Routine Rehabilitation Exercise Guidance
Lead sponsor: Navamindradhiraj University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the accuracy of physical therapy in various positions after 4 weeks of training, comparison of the accuracy in rehabilitation exercise between mobile application actuated rehabilitation exercise guidance and routine rehabilitation exercise guidance for the primary osteoarthritis knee patients


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of knee
* Have an android phone and use the application

Exclusion Criteria:

* There are other complications that may affect physiotherapy
* Communication problems
* Has been trained in physical therapy for osteoarthritis patients
* Have had total knee arthroplasty

Primary outcomes:
measure: Outcome measurement to compare the accuracy
timeFrame: 1 month
measure: Patient satisfaction of rehabilitation method
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dusit
country: Thailand
facility: Navamindradhiraj University
state: Bangkok,
city: Dusit
country: Thailand
facility: Navamindradhiraj University
state: Bangkok
Study officials:
affiliation: Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
name: Satit Thiengwittayaporn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thiengwittayaporn S, Wattanapreechanon P, Sakon P, Peethong A, Ratisoontorn N, Charoenphandhu N, Charoensiriwath S. Development of a mobile application to improve exercise accuracy and quality of life in knee osteoarthritis patients: a randomized controlled trial. Arch Orthop Trauma Surg. 2023 Feb;143(2):729-738. doi: 10.1007/s00402-021-04149-8. Epub 2021 Aug 28.
Clinical trial NCT01932385: Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
Official title: Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Liver Cancer
Keywords: Sorafenib
Hepatocellular carcinoma
Best supportive care
Survival
Lead sponsor: Qingdao Central Hospital
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.


Eligibility criteria: Inclusion Criteria:

* pathological or cytological confirmed advanced hepatocellular carcinoma
* 18 years to 80 years
* liver function Child-Pugh class B
* BCLC stage B or C
* estimated life time 2 months or longer

Exclusion Criteria:

* previous target therapy
* allergy to Sorafenib
* Uncontrolled Bleeding or diarrhea
* eligible for locoregional treatment

Primary outcomes:
measure: progression free survival and overall survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause up to 12 months
Secondary outcomes:
measure: response rate
timeFrame: every 4 weeks till progression, total up to 12 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Central Hospital, Qingdao Cancer Hospital
state: Shandong
Study officials:
affiliation: Qingdao Health Bereau
name: ketao lan, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00719485: A Study on the Use of Educational Programs Prior to Lumbar Spinal Surgery
Official title: A Prospective Randomized Control Trial Assessing the Effect of Two Different Educational Programs on Functional Outcome and Quality of Life Scores for Patients Having Posterior Decompressive Lumbar Spinal Surgery for Degenerative Conditions of the Lumbar Spine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decompression, Surgical
Keywords: lumbar decompression
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluated the hypothesis that the implementation of an educational program that informs spine patients about their condition, treatment options, prioritization on the wait list, and post-operative care would improve functional outcome and quality of life scores following surgery

Detailed description: Previous literature has shown that longer waits to lumbar spine surgery can have negative effects on the patients perceived function and quality of life both pre- and post-operatively. Patients report deterioration during this long wait, commonly over 6 months in Ontario. The proposed study intends to evaluate the impact of two different educational methods for patients undergoing lumbar spine surgery. This prospective randomized clinical trial will assign patients to two different educational groups: one of solely standard care, and the other of standard care with the addition of presentation of a 10 minute educational video informing spine patients about their condition, treatment options, prioritization on the wait list and post-operative care. Outcome measures will be assessed through four different questionnaires concerning specific conditions, pain, quality of life, etc., both pre-operatively and post-operatively. Providing patients with this accurate information may coincide with positive outcome measures. The more successful educational program, as found by this study, may then be provided to all spine patients. This educational program may bring about an increase in overall well-being of spine patients by having a positive impact on the quality of life both pre- and post-operatively.

Eligibility criteria: Inclusion Criteria:

* Degenerative condition of the lumbar spine requiring decompressive surgery

Exclusion Criteria:

* emergent spinal condition
* acute bowel/bladder dysfunction
* cervical spine condition
* inability to participate in follow up and/or functional tests or questionnaires during study timeline (due to substance abuse, etc...)
* revision surgery

Primary outcomes:
measure: Functional outcome scores
timeFrame: 2 years following surgery
Secondary outcomes:
measure: Quality of life scores
timeFrame: 2 years following surgery
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Albert Yee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00412685: Myocardial Contrast Echocardiography in Congenital Heart Disease
Official title: Quantification of the Myocardial Microcirculation by Contrast Echocardiography In Adult Patients With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: D-Transposition of Great Arteries
Tetralogy of Fallot
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2006-12-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is divided in three groups, which are all age- and gender-matched. The TGA group consists of 15 patients treated withMustard or Senning procedures for surgical repaired of D-TGA atrial switch operation. The TOF group consists of 15 patients with surgically corrected TOF. The control group C consists of 15 control subjects (AH) with normal Doppler Echocardiographic echocardiographic examinations.

Brief summary: Patients with congenital heart disease in whom the right ventricle is exposed to pressure or volume overload show progressive systolic dysfunction of the right ventricle, the fact of which conveys substantial morbidity and mortality. The aim of this study is to investigate the myocardial perfusion in these patients by myocardial contrast echocardiography (MCE) in order to determine whether disturbed blood flow plays a role in the development of right ventricular systolic dysfunction.


Eligibility criteria: Inclusion Criteria:

* D-TGA or Fallot-Tetralogy or Healthy person
* written informed consent
* Age \>= 18 years

Exclusion Criteria:

* Anaemia
* Pregnancy and breast feeding
* Diabetes mellitus
* Contraindications to stress testing (ergometry or adenosine)
* Known adverse reaction or hypersensitivity against V08DA (SonoVue) or its components or against adenosine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Inselspital
Study officials:
affiliation: University Hospital Berne, Switzerland
name: Christian Seiler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03901885: Sexual Health After Endometriosis Surgery
Official title: Impact of Deep Endometriosis Surgery on Sexual Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Endometriosis is a disease affecting between 5 and 15% of women and more than 40% of infertile women.

The main stakes of this disease are that it is benign but difficult to diagnose, often very painful, difficult to predict, potentially recurrent, while being resolvable at menopause. It affects women of childbearing age and can cause infertility and pain during intercourse. Also, by its characteristics, it can significantly deteriorate the quality of life.

The management of endometriosis, from diagnosis to treatment, is not consensual. There are medical or surgical treatments depending on the severity of the lesions, their location and the severity of the symptoms. Deep endometriosis, that is to say when there is digestive, urinary, utero sacral or peritoneal ligament more than 5mm deep, poses, in particular, a therapeutic problem because surgery is often the only option but it can be decadent.

Due to genital involvement, this disease has a real impact on the sexuality of patients. Surgery allows in a number of cases to reduce pain, including those occurring during intercourse. But the impact on sexuality in a more global way remains to be studied. The latter can be improved by the reduction of pain, but impacted by the surgery which is not insignificant on the representation of the woman of her own body.


Eligibility criteria: Inclusion Criteria:

* Major women operated for deep endometriosis at the Lyon Sud Hospital Center (CHLS) of the Hospices Civils de Lyon (HCL).

Exclusion Criteria:

* Minor patient
* No indication for operation or indication of hysterectomy
* Isolated uterine adenomyosis
* Patient opposing her participation in the study

Primary outcomes:
measure: Consequences of the surgical management of a deep endometriosis on the quality of the sexual life of the patients.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Mathieu Poilblanc, MD
role: PRINCIPAL_INVESTIGATOR
References: