louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03359499: Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients
Official title: Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Irritable Bowel Syndrome
Lead sponsor: Hospital Britanico
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 80
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: Probiotics have been proposed as useful therapeutic alternatives for the treatment of irritable bowel syndrome patients. Bacillus clausii is a probiotic that has been used for the treatment of acute diarrhea among adults and pediatric patients, as well as an adjunctive therapy for the treatment for Helicobacter pylori infection. It has been proposed that Bacillus clausii is effective for the treatment of irritable bowel syndrome-related symptoms (especially diarrhea and bloating) in non-controlled trials. The aim of the proposed investigation is to determine whether the administration of Bacillus clausii during two weeks plus dietary advice compared to antispasmodics plus dietary advice would be an effective and safe alternative.


Eligibility criteria: Inclusion Criteria:

* Adult patients with non-constipated irritable bowel syndrome according to Rome IV criteria

Exclusion Criteria:

* Allergy to Bacillus clausii spores
* Prior treatment with antibiotics or probiotics (4 weeks)
* Not willing to fulfill symptom diary
* Pregnancy or breastfeeding
* Clinical suspicion of organic disease

Primary outcomes:
measure: Symptomatic response
timeFrame: After two weeks of treatment
Secondary outcomes:
measure: Symptomatic relapse
timeFrame: Four weeks after treatment completion
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Britanico
state: Caba
Study officials:
affiliation: Hospital Britanico
name: Juan S Lasa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05726799: Use of Cryoenergy to Faciltate Myectomy in Hypertrophic Obstructive Cardiomyopathy: Comparison With the Classical Approach
Official title: Use of Cryoenergy to Faciltate Myectomy in Hypertrophic Obstructive Cardiomyopathy: Comparison With the Classical Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septal Hypertrophy
Obstructive Hypertrophic Cardiomyopathy
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients needing a myectomy due to obstructive hypertrophyc cardiomyopathy

Brief summary: In some patients, septal hypertrophy extends more distally, from the subaortic portion of the septum to the midventricular portion. In these patients, classic transaortic surgical myectomy may not be effective in removing the midventricular obstruction, resulting in a suboptimal surgical outcome. These patients may present recurrence of symptoms and not have an improvement in the prognosis related to the treatment of hypertrophic cardiomyopathy, in some cases determining the need for reoperation. Since 2015, our Institute has used a surgical technique that allows us to improve transaortic exposure of the interventricular septum, using a probe with application of cryoenergy the hypertrophic portion of the septum is hooked and in this way the myectomy can be extended more distally, performing a more complete removal of the myocardium.

The aim of this study is to compare the results obtained with classical myectomy compared to myectomy performed with the aid of cryoenergy.

The primary endpoint is the comparison in terms of mortality between patients undergoing classical myectomy versus those undergoing cryoenergy-assisted myectomy.

Secondary endpoints are: extent of myectomy, persistence of residual left ventricular outflow tract obstruction, persistence of mitral regurgitation related to systolic anterior motion of the mitral leaflets, occurrence of ventricular defect, and need for PM implantation.


Eligibility criteria: Inclusion Criteria:

* adult patients (≥ 18 years)
* meeting the clinical and echocardiographic criteria that made them candidates for isolated myectomy or in combination with other surgical procedures:
* LV outflow tract instantaneous peak gradient \>50mmHg at rest or during stimulation
* interventricular septum \>16mm,
* NYHA functional class III-IV, despite maximal medical therapy
* operated in San Raffaele Hospital with classic or cryo myectomy between 2015 and 2018.

Exclusion Criteria:

* extent of myectomy not reported in the operative report;
* left ventricular outflow tract gradient not reported in pre- or postoperative echocardiography.

Primary outcomes:
measure: Mortality
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT01776099: Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes
Official title: Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
nutrition
fibers
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Firma Rettenmeier & Söhne (Company)
name: German Center for Diabetes Research
First posted: 2013-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In animal models and retrospective studies, certain food components such as sugars and fiber have been detected as potential agents to influence development and progress of type 2 diabetes.

The DiNA study prospectively investigates, if non-soluble non-fermentable fibers (vs. soluble ones) and galactose (vs. palatinose) are capable to improvement metabolic parameters in patients with long-term type 2 diabetes and intensive insulin treatment.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes, insulin-dependent
* high insulin resistance

Exclusion Criteria:

* accompanying disease, medication or metabolic disorder, which interact with glucose metabolism or eating behavior (e.g. renal insufficiency, major cardial insuffiency, untreated hypothyreosis, corticoid treatment, depression and other psychiatric disorders...)

Primary outcomes:
measure: metabolic improvement of type 2 diabetes
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité-Klinikum Benjamin Franklin
Study officials:
affiliation: German Institute for Human Nutrition
name: Andreas F.H. Pfeiffer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05824299: Influence of Anesthesia Methods on CTCs in TURBT Patients
Official title: Influence of General Anesthesia Versus Spinal Anesthesia on Circulating Tumor Cells in Patients Undergoing Transurethral Resection of Bladder Tumor
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bladder Cancer
Keywords: Circulating Tumor Cells
General Anesthesia
Spinal Anesthesia
Transurethral Resection of Bladder Tumor
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Multiple lines of evidence have shown that anesthesia method is associated with long-term outcomes in patients undergoing surgery due to cancers, including lung, breast, prostate, and bladder cancer, etc. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of anesthesia methods on the number of CTCs in patients receiving transurethral resection of bladder tumor (TURBT). The difference of anesthesia method is achieved by using general anesthesia in one group and spinal anesthesia in the other group.


Eligibility criteria: Inclusion Criteria:

1. .≤18 Age ≤85，ASAI-III.
2. .Patients with primary bladder cancer of Stage T1 to T4, who are scheduled for transurethral resection of bladder tumor.
3. .Written informed consent.

Exclusion Criteria:

1. History of surgery within 6 months.
2. Contraindications for spinal anesthesia.
3. With a history of any other malignancy.
4. Having received preoperative neoadjuvant therapy.
5. History of long-term opioid use.
6. Combined with autoimmune diseases or having a history of prolonged hormone use or immunosuppressant use within 1 year.
7. Combined with impaired liver function (Child - Pugh C) or renal insufficiency (serum creatinine level over 442μmol•L-1).
8. Known hypersensitivity or suspected allergy to intervention drugs.
9. Proposed postoperative admission to ICU.

Primary outcomes:
measure: the number of Circulating Tumor Cells
timeFrame: on the Day 7~10 after surgery
Secondary outcomes:
measure: Surgeon Satisfaction
timeFrame: immediately after surgery
measure: Patient Satisfaction
timeFrame: within 24 hours after surgery
measure: Visual Analogue Scale
timeFrame: at 24 hours after surgery
measure: Nausea Score
timeFrame: at 24 hours after surgery
measure: Hospitalization Days
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT05141799: Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis
Official title: Effectiveness of High-intensity Laser Therapy in De Quervain Tenosynovitis; a Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: De Quervain Disease
Keywords: Hand grip strength
high-intensity laser therapy
De Quervain Disease
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 68 De Quervain tenosynovitis(MPS) diagnosed patients will be randomly divided into 2 groups. To groups; splinting+exercise+high-intensity laser therapy (HILT) and splinting+exercise+sham HILT will be applied. Visual anolog scale (VAS) scores, quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire and Hand grip strength measurements of the patients before-after treatment will be recorded and will be evaluated statistically.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with unilateral De Quervain tenosynovitis 18-65 years old

Exclusion Criteria:

* pain history of less than four weeks,
* upper extremity entrapment neuropathy,
* major psychiatric disease,
* upper extremity surgical treatment history,
* malignancy history,
* chronic rheumatic disease,
* cervical radiculopathy,
* cervical myelopathy,
* local corticosteroid injection prior to De Quervain tenosynovitis and receiving physical therapy.

Primary outcomes:
measure: quick Disabilities of the Arm, Shoulder, and Hand (QDASH) questionnaire
timeFrame: 5 Minutes
measure: JAMAR hydraulic hand dynamometer
timeFrame: 2 minutes
Secondary outcomes:
measure: visual analog scale (VAS)
timeFrame: 10 Seconds
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Private Medar Hospital
state: Golcuk
Study officials:
affiliation: Kocaeli University
name: Emine Dundar Ahi, assist prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05189899: Pain's Treatment With Virtual Reality in Hemodialysis
Official title: Pain's Treatment With Virtual Reality in Hemodialysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Pain
Chronic Kidney Diseases
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover clinica trial
Primary purpose: TREATMENT

Brief summary: Pain is a frequent and difficult to treat symptom in patients with advanced kidney disease undergoing hemodialysis. Pharmacokinetics and pharmacodynamics have complex pharmacokinetics and pharmacodynamics in these types of patients, so non-pharmacological therapies could be very useful. In this project the investigators propose to test whether the use of a virtual reality platform, designed by the company Psious and tested in other clinical settings, can reduce the pain that patients experience during connection to the dialysis session.

For this the investigators have designed a crossover clinical trial, which will be carried out on 107 hemodialysis patients, in which the intensity of pain (primary objective) and anxiety (secondary objective) that patients experience in the sessions in which participants are treated Using virtual reality, it will be compared with the intensity of pain and anxiety experienced by these same patients, in sessions in which the virtual reality platform is not used.

The results of this clinical trial can support the use of virtual reality as an adjunctive pain treatment in patients with advanced kidney disease.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis for at least 3 months
* Pain for for at least 3 months
* Signature of informed consent

Exclusion Criteria:

* Pain from a traumatology disease
* Formal diagnose of dementia

Primary outcomes:
measure: Pain measured by using the revised Faces Pain Scale - Revised (FPS-R)
timeFrame: From the moment of connection to dialysis until 30 minutes later
Secondary outcomes:
measure: Anxiety measured by using the Hamilton scale
timeFrame: From 1 hour before dialysis connection to 30 minutes after
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01010399: Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
Official title: A Pilot, Open-Label Study of Adjunctive Therapy With Lovaza® in Hypertriglyceridemic, HIV-Infected Subjects Who Switched Protease Inhibitor to Once-Daily Lexiva® 1400mg Plus Norvir® 100mg Plus Optimized Background
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertriglyceridemia
HIV Infection
Keywords: HIV
triglycerides
fosamprenavir
Lead sponsor: Felizarta, Franco, M.D.
Sponsor class: INDIV
Collaborators: name: GlaxoSmithKline
First posted: 2009-11-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result in 30% of patients achieving a reduction in fasting triglycerides \< 200 mg /dL while maintaining virologic suppression.


Eligibility criteria: Inclusion Criteria:

* fasting triglycerides \>= 200 mg/dL but \<1,200 mg/dL
* fasting LDL \<= 160 mg/dL
* participation in a lipid-lowering diet and exercise program for at least 28 days
* treatment with stable HAART consisting of first or second RTV-boosted PI regimen plus optimized background ART for at least 3 months
* plasma HIV-1 RNA \<50 copies/mL
* CD4+ cell count \>50 cells/mm3
* male subjection testosterone replacement therapy with total testosterone level \<= 1 x upper limit of normal
* female study volunteer must use a form of contraception
* ability and willing ness to give written informed consent

Exclusion Criteria:

* any Grade 4 laboratory abnormality
* currently taking amprenavir or fosamprenavir
* required a second RTV-boosted PI for reasons of virologic failure
* atherosclerotic disease risk
* congestive heart failure (NYHA Class III or IV)
* uncontrolled hypertension
* history of pancreatitis
* active bleeding disorder
* recent history of significant renal, pulmonary, biliary, hepatic or gastrointestinal disease
* current diabetes mellitus requiring pharmacological treatment
* use of systemic cancer chemotherapy; active cancer
* pregnancy or breast-feeding
* requirement for any lipid-lowering agent after baseline
* use of hormonal anabolic therapies, systemic steroids, immune modulators
* use of anticoagulants, investigational antiretroviral drugs
* allergy to study drugs
* active CDC clinical category C event

Primary outcomes:
measure: Proportion of Subjects With Triglycerides <200 mg/dL
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of Subjects With HIV-1 RNA <50 Copies/mL
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Franco Felizarta, MD
state: California
Study officials:
affiliation: Franco Felizarta, MD
name: Franco Felizarta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02366299: Comparison of Dexmedetomidine and Propofol on the Delirium and Neuroinflammation in Patients With SIRS.
Official title: Comparison of Sedative Effects of Dexmedetomidine and Propofol on the Clinical Course of Delirium and Neuroinflammation in Patients With SIRS.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Delirium
Lead sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
Sponsor class: OTHER_GOV
First posted: 2015-02-19
Enrollment: 0
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: Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of delirium and neuroinflammation in patients with SIRS using CAM-ICU scale and protein S100b in serum.


Eligibility criteria: Inclusion Criteria:

* presence of delirium

Exclusion Criteria:

* presence of Alzheimer's disease
* any mental disorder
* presence of cancer

Primary outcomes:
measure: CAM-ICU scale
timeFrame: up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05782699: Detecting Syncope by an Integrated Multisensor Patch-type Recorder
Official title: Detection of Impending Reflex Syncope by Means of an Integrated Multisensor Patch-type Recorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope, Vasovagal
Keywords: syncope
tilt table test
blood pressure monitoring
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to assess the reliability of a new cuffless patch BP monitor in detecting episodes of hypotensive (pre)syncope during tilt testing.

Detailed description: Background While ECG monitoring is a reliable and established method that allows to document bradycardia in a substantial proportion of patients affected by cardioinhibitory reflex syncope, the documentation of a transient hypotension is only seldom achieved in patients affected by hypotensive syncope. Conventional ambulatory blood pressure (BP) monitoring (ABPM) has important limitations due to the short period of monitoring (usually 24-48 hours) and the intermittent nature of BP measurements (usually every 15-20 min).

The main purpose of this study is to assess the reliability of a new cuffless patch BP monitor in detecting episodes of hypotensive (pre)syncope. Secondary aim regards the estimation of feasibility of this tool.

Method The study is a prospective intrapatient comparison between BP measured by mean of a cuffless patch BP monitor (RootiRX System, Rooti Labs Ltd., Taipei, Taiwan) and by mean of the standard method during tilt testing.

Study design BP values observed during tilt testing baseline and at the time of impeding syncope will be measured by mean of the RootiRX device and will be compared with the standard of reference. BP will be recorded at rest at baseline, shortly after upright in tilting position (at stabilization), at the time of occurrence of syncope (presyncope) or, alternatively at the time of maximum hypotensive effect, if syncope will not occur, and finally in the recovery period at the end of the test after returning in supine position.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients,
* \>18 years of age,
* referred for tilt testing because affected by suspected reflex syncope

Exclusion Criteria:

* Incapability to perform tilt testing

Primary outcomes:
measure: BP pattern
timeFrame: 2 hours
Secondary outcomes:
measure: BP drop
timeFrame: 2 hours
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Auxologico Italiano
state: MI
Study officials:
References: