louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02294292: Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its Impact on Morbidity and Mortality
Official title: Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its' Impact on Morbidity and Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastolic Dysfunction
Chronic Liver Disease
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of complications in liver disease. The purpose of this prospective, randomized controlled trial is to determine whether carvedilol can revert cardiac dysfunction i.e. left ventricular diastolic dysfunction secondary to cirrhosis, and prevent complications (renal dysfunction, worsening cardiac function, and mortality).


Eligibility criteria: Inclusion Criteria:

Patients with cirrhosis who have been diagnosed by clinical, biochemical,or histological (when available) criteria plus ultrasound imaging.

* Age range of 18-60 years
* Cirrhosis as diagnosed by histology or clinical, laboratory and USG (UltraSonography) findings,
* Upper GI bleed who are undergoing secondary endoscopic variceal ligation for eradication of varices

Exclusion Criteria:

* Age \>60 years
* Chronic renal disease
* Pregnancy and peripartum cardiomyopathy
* Hypertension
* Coronary artery disease
* Valvular heart disease
* Sick sinus syndrome/ Pacemaker
* Cardiac rhythm disorder
* Hypothyroidism
* Hyperthyroidism
* Portal vein thrombosis
* Transjugular intrahepatic porto systemic shunt (TIPS) insertion
* Hepatocellular carcinoma
* Anemia Hb \< 8gm/dl in females, and \< 9 gm/dl in males

Primary outcomes:
measure: Progression of cirrhosis and its complications.
timeFrame: 1 Year
Secondary outcomes:
measure: Improvement in left ventricular diastolic function in either arm.
timeFrame: 1 Year
measure: Renal function
timeFrame: 1 Year
measure: Serum level of Brain Natriuretic Peptide.
timeFrame: 1 Year
measure: Mortality
timeFrame: 1 Year
measure: Quality of life
timeFrame: 1 Year
measure: Electrophysiologic modifications
timeFrame: 1 Year
measure: Serum level of catecholamines
timeFrame: 1 year
measure: Serum level of plasma renin activity
timeFrame: 1 Year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
citation: Premkumar M, Rangegowda D, Vyas T, Khumuckham JS, Shasthry SM, Thomas SS, Goyal R, Kumar G, Sarin SK. Carvedilol Combined With Ivabradine Improves Left Ventricular Diastolic Dysfunction, Clinical Progression, and Survival in Cirrhosis. J Clin Gastroenterol. 2020 Jul;54(6):561-568. doi: 10.1097/MCG.0000000000001219.
Clinical trial NCT05110092: Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers
Official title: Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot
Resistance Exercise
Wound Healing
Hyperglycemia
Quality of Life
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-11-05
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study was designed leg resistance training combined with breathing approach, and evaluated its effect on wound healing, blood sugar control and quality of life in type 2 diabetic patients with foot ulcers.

Detailed description: A randomized controlled trial was used. type 2 diabetic patients who suffered from foot ulcers were recruited from one medical center of Northern Taiwan, and randomly assigned into the exercise or control group. The control group received usual care for diabetic foot. The exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks. Outcomes were measured by wound healing area, the fasting of blood glucose, hemoglobin A1c (HbA1c), and the World Health Organization quality of life-BREF (WHOQOL-BREF) before the intervention as baseline, and the 4th, 8th and 12th weeks during the intervention period.

Eligibility criteria: Inclusion Criteria:

* patients 20 years or older
* who were diagnosed with type 2 diabetic foot
* ulcers of Meggitt-Wagner Grade 1-2
* who were conscious and could perform the prescribed exercise.

Exclusion Criteria:

* peripheral arterial occlusion disease
* osteomyelitis
* inability to perform exercise as assessed by physicians.

Primary outcomes:
measure: wound healing
timeFrame: during 12 weeks the intervention period.
measure: blood sugar control-fasting blood sugar
timeFrame: during 12 weeks the intervention period.
measure: quality of life measured by the World Health Organization Quality of Life-BREF
timeFrame: during 12 weeks the intervention period.
measure: blood sugar control-HbA1c
timeFrame: during 12 weeks the intervention period.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01813292: Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV Patients Treated With Tenofovir +/- Emtricitabine
Official title: Comparative Study of Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV + Men Being Given Tenofovir With FTC, Emtricitabine (TRUVADA®), or Without (VIREAD®), as Part of Their Antiretroviral Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Seropositivity
Keywords: male patients
treated by TRUVADA® or VIREAD® for more than 60 months
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 103
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months.

Brief summary: HIV+ patients are considered at risk for excessive bone fragility. Several factors could contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed as TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine (3TC) but is 5-fluorinated, the daily intake of fluoride is \~15 mg. Fluoride induces bone formation by stimulating osteoblasts, of often impaired bone quality.

The aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal, bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months. The patients will be randomly selected, then matched according to age, ethnic origin, BMI.

Detailed description: Fluoride metabolism will be studied by measurement of fluoride in blood and in daily urine, bone remodelling by measurement of P1NP. Dual X-ray absorptiometry (DXA) will be used to determine the areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius. Volumetric BMD (v-BMD) and micro-architecture of distal radius and tibia will be studied using a HR-pQCT scan (Xtreme, Scanco).

Eligibility criteria: Inclusion Criteria:

* HIV+ patients
* male patients
* patients treated by tenofovir+emtricitabine(TRUVADA®) or tenofovir(VIREAD®) for more than 60 months.

Exclusion Criteria:

* chronic use of fluoroquinolones, antifungal agents, steroids
* malignancy (current or previous) requiring chemotherapy or radiotherapy

Primary outcomes:
measure: Areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius measured by Dual X-ray absorptiometry (DXA)
timeFrame: ongoing, during the study period, according to the availability of DXA
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisiere
Study officials:
affiliation: Hopital Lariboisiere, Paris, France
name: Pierre O Sellier, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04735692: Effectiveness of Periodontal Therapy on Periodontal Bacteria
Official title: Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 88
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergo non-surgical quadrant scaling and root planing
Primary purpose: TREATMENT

Brief summary: In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of Periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to full mouth scaling or quadrant scaling

Detailed description: This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of Messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 88 patients, aged 27 to 65 (mean age 57) were assessed for eligibility. In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 180 days after therapy.

Eligibility criteria: Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Clinical attachment level
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
state: CT
Study officials:
affiliation: Università degli Studi di Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02283892: Respiratory Complaints Checklist Trial
Official title: Randomized Clinical Trial of the Impact of a Respiratory Complaints Assessment Checklist on Resources Utilization and Clinical Outcomes in an Acute Evaluation Outpatient Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Cough
Keywords: respiratory complaints
dyspnea
cough
checklist
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 39
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 is a randomized clinical trial that evaluates the impact of using an internet-based checklist for systematic assessment of patients reporting respiratory complaints with the conventional assessment, without using the checklist.

Detailed description: This is a randomized clinical trial that evaluates the impact of using an internet-based checklist for systematic assessment of patients reporting respiratory complaints with the conventional assessment, without using the checklist.

Study setting: emergency department related acute evaluation outpatient clinic

Inclusion criteria: 18 years of age or older; patients presenting to the ED reporting cough or dyspnea;

Exclusion criteria: acute respiratory failure; SpO2 \< 92%; any signs of hemodynamic or respiratory instability; possible concurrent diagnosis requiring immediate assessment (e.g..: acute coronary syndrome or stroke; )

Primary outcome: need of reassessment in the ED or hospitalization within 1 month of index evaluation (intervention).

Secondary outcomes: number of complete blood counts ordered in the index evaluation; number of other diagnostic tests ordered in the index evaluation;

Randomization: block 1:1; stratified by gender and age (\>50 years old).

Masking will be appllied to: patients; outcome assessors; data analysts;

Eligibility criteria: 18 years of age or older; patients presenting to the ED reporting cough or dyspnea; legally capable.

Exclusion criteria: acute respiratory failure; SpO2 \< 92%; any signs of hemodynamic or respiratory instability; possible concurrent diagnosis requiring immediate assessment (e.g..: acute coronary syndrome or stroke; )

Primary outcomes:
measure: Need to visit the emergency department or acute evaluation outpatient clinic
timeFrame: 1 month
measure: Complete blood count ordered in the index evaluation
timeFrame: 1 month
Secondary outcomes:
measure: Number of diagnostic tests ordered in the index evaluation
timeFrame: 1 month
measure: Hospital admission
timeFrame: 1 month
measure: Antibiotics prescription
timeFrame: 1 month
measure: Major events
timeFrame: 1 month
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
References:
Clinical trial NCT01614444: Acupressure and Stress Resilience
Official title: Using Complementary and Alternative Medicine (CAM) to Promote Stress Resilience in Those With Co-Occurring Mild TBI and PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder (PTSD)
Mild Traumatic Brain Injury (mTBI)
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: University of Colorado, Boulder
name: United States Department of Defense
First posted: 2012-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study will assess the efficacy of acupressure, a type of complementary and alternative medicine (CAM) in the Veteran population. Veterans with co-occurring mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) will be consented and randomly assigned to either an active or placebo acupressure treatment series of 8 sessions. The investigators will determine if acupressure affects aspects of day-to-day function, such as memory, sleep, mood, psychiatric health and stress resilience. This information will help identify potential treatment strategies to improve quality of life and overall function in this particular Veteran population.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-60
* Diagnosis of mild TBI and PTSD as assessed by interview and/or chart review
* Currently receiving or eligible to receive physical and/or mental healthcare through the VA Eastern Colorado Health Care System

Exclusion Criteria:

* History of other significant neurological disease (e.g., Alzheimer's, Parkinson's, multiple sclerosis etc.) as assessed by interview and/or chart review. Such conditions could affect outcome measures independently, thereby creating an experimental confound.
* History or diagnosis of lifetime moderate to severe TBI, as assessed by interview and/or chart review.
* History of psychotic disorder or bipolar I disorder as assessed by structured interview. Such conditions could affect outcome measures independently, thereby creating an experimental confound.
* Inability to read the informed consent document or adequately respond to questions regarding the informed consent procedure.
* Prior experience with acupressure, as this would result in individuals potentially being able to detect Placebo treatments if randomly assigned to that group.

Primary outcomes:
measure: Trier Social Stress Test
timeFrame: 72 hours post final acupressure treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver VAMC
state: Colorado
Study officials:
affiliation: Senior Investigator and Research Psychologist Eastern Colorado Healthcare System, VISN19, MIRECC
name: Theresa D Hernandez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Colorado Healthcare System VISN 19 MIRECC Director
name: Lisa A Brenner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01627444: Acupuncture in Mothers of Very Low Birth Weight Infants
Official title: Ear Acupuncture for Anxiety in Mothers of Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anxiety
Keywords: Acupuncture
Anxiety
Human Milk
Very low birth weight infants
Mother of very low birth weight infants
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Does ear acupuncture reduce anxiety in mother of very low birth weight infants?


Eligibility criteria: Inclusion Criteria:

* can read and write in portuguese

Exclusion Criteria:

* breastfeeding contraindication
* use of lactogogues

Primary outcomes:
measure: Reduced anxiety
timeFrame: at least 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Hospital Universitário de Londrina
state: Paraná
Study officials:
References:
Clinical trial NCT00463944: Assessment of an Electronic Voting System Within the Tutorial Setting. A Randomised Controlled Trial
Official title: Assessment of an Electronic Voting System Within the Tutorial Setting. A Randomised Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Electronic voting system
Lead sponsor: University of Adelaide
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: A study of an electronic voting system as a learning aid during tutorials

Detailed description: A study of an electronic voting system as a learning aid during tutorials. This study was undertaken with clinical students over a one year period of observation

Eligibility criteria: Inclusion Criteria:

* All fourth year students

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: University of Adelaide
state: South Australia
Study officials:
affiliation: University of Adelaide
name: Peter Devitt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02623244: The Association Between Ovarian Endometrioma and Lower Urinary Tract Symptoms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Endometrioma
Keywords: ovarian endometrioma
lower urinary tract symptoms
sexual dysfunction
gastrointestinal symptoms
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with ovarian endometrioma

Brief summary: To assess the relationship between ovarian endometrioma and lower urinary tract symptoms, sexual function and gastrointestinal symptoms. In addition, the investigators also assess the impact of surgeries for ovarian endometrioma on lower urinary tract symptoms, sexual function and gastrointestinal symptoms.

Detailed description: All patients were found to have ovarian endometrioma were invited to participate in this study. The size and location of ovarian endometrioma should be assessed by ultrasonography. Besides, all enrolled female patients will be asked to complete overactive bladder symptom score, female bladder function, female sexual function, and bowel incontinence assessment questionnaires and CA125 level. In addition, patients who underwent surgeries for ovarian endometrioma will be requested to complete the above questionnaires and CA125 check-up at 3 \& 6 months after surgery. At least 30 women with age and body mass index matched and without ovarian endometrioma will be invited to participate in this study as the control group.

Eligibility criteria: Inclusion Criteria:

1. \>20 years old.
2. Ovarian endometrioma: women having a frosted glass content in ovarian cyst

Exclusion Criteria:

1. The patient is acute lower urinary tract infection or intestinal inflammation.
2. Had received surgery bladder or urethra.
3. Patients with a history of urinary tract stones or tumors.

Primary outcomes:
measure: The association of ovarian endometrioma and overactive bladder symptoms score
timeFrame: 1 week
Secondary outcomes:
measure: The association between ovarian endometrioma and female sexual function index score
timeFrame: 1 weeks
measure: The association between ovarian endometrioma and bowel incontinence assessment score
timeFrame: 1 weeks
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
affiliation: Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Banqiao, New Taipei, Taiwan
name: Sheng-Mou Hsiao, MD
role: PRINCIPAL_INVESTIGATOR
References: