louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06738420: Medical Nutrition Formulations Enriched with Postbiotics for the Management of Gastrointestinal Disorders
Official title: Efficacy and Tolerability of a Nutritional Supplementation with Medical Nutrition Formulations Enriched with Postbiotics for the Management of Gastrointestinal Disorders: a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diarrhoea of Diverse Aetiology Requiring Oral Rehydration Therapy
Diarrhoea and Gastrointestinal Symptoms Secondary to Enteral Nutrition
Keywords: diarrhoea
postbiotic
adults
Lead sponsor: AB Biotek
Sponsor class: INDUSTRY
Collaborators: name: Colisée Barcelona Isabel Roig
name: Grupo Colisée
First posted: 2024-12-17
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: Efficacy and tolerability of ABB i5 prebiotic and ABB C22 postbiotics for the management of constipation and gastrointestinal well-being: a pilot trial


Eligibility criteria: Inclusion Criteria:

* Inpatients of the centre

  * Diagnostic of diarrhoea: increase in daily faecal weight \> 200 g (as per the Centre protocol).
  * Subjects who as per the Centre protocol require Oral rehydration therapy
  * Patients with the ability to take the study product orally

Exclusion Criteria:

* History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.

  * History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
  * Patients in situation of last days
  * Amytriptilin and masalazine treatment (anti-depressives)
  * Laxatives

Primary outcomes:
measure: Faecal calprotectin
timeFrame: from baseline to day 14 of supplementation
measure: faecal lactoferrin
timeFrame: from baseline to day 14 of supplementation
measure: Blood IgAs
timeFrame: from baseline to day 14 of supplementation
Secondary outcomes:
measure: Gastrointestinal symptoms
timeFrame: from baseline to day 14 of supplementation
measure: faecal consisitency
timeFrame: from baseline to day 14 of supplementation
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Isabel Roig
Study officials:
References:
Clinical trial NCT05945420: Adding Desmopressin to Tamsulosin for Treatment of BPH
Official title: Outcome of Adding Desmopressin to Tamsulosin for Treatment of Nocturnal Polyurea in Patients With Benign Prostatic Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Nocturnal Polyurea in Patients With BPH
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 160
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study investigators will add desmopressin for treatment of patients with benign prostatic hyperplasia and nocturnal polyurea

Detailed description: Investigators will give a group of patients tamsulosin and desmopressin and the other group will take tamsulosin and placepo and compare the outcome regarding symptoms of being prostatic hyperplasia especially nocturia and the effect on nocturnal polyurea in patients

Eligibility criteria: Inclusion Criteria:

Men with BPH Age more than 50years Patients with nocturia (2voids per night or More) Patients with nocturnal polyurea (urine volume More than 33%of urine allover the day) IPSS more than 12 Obstructed flow curve Post voiding residual less than 150

Exclusion Criteria:

* men with BPH with : Acute urine retention Neurogenic bladder dysfunction Cardiovascular disease Hyponatremia Urethral stricture Bladder calculi Prostate cancer

Primary outcomes:
measure: Change of symptoms and nocturia disappears or improve
timeFrame: Follow up for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and nephrology center
state: Outside U.S./Canada
Study officials:
References:
Clinical trial NCT01305720: The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants
Official title: The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prematurity of Fetus
Keywords: mydriatic
NIRS
preterm
eye drops
cerebral
mesenteric oxygenation
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 28
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral and mesenteric oxygenation in newborn infants. Using this technique the investigators investigated the effect of mydriatic eye drops on cerebral and mesenteric oxygenation in preterm infants

Detailed description: The cerebral and mesenteric oxygenation will be measured by NIRS before, during and after the mydriatic eye drops are instilled.

Eligibility criteria: Inclusion Criteria:

1. \< 32 gestational age and/or \< 1500gr.
2. ≥ 28th day preterm infants
3. Instilled mydriatic eye drops for ROP examination

Exclusion Criteria:

1. Sepsis
2. Shock
3. Severe intracranial hemorrhage
4. NEC
5. Abdominal and cranial surgery

Primary outcomes:
measure: The Effect of Mydriatic Eye Drops on Cerebral and mesenteric Oxygenation
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity and Teaching Hospital
Study officials:
References:
Clinical trial NCT02845674: An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Official title: An Open-Label Extension of a Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconjunctivitis Sicca
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2016-07-27
Enrollment: 258
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: This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)


Eligibility criteria: Inclusion Criteria:

* Completion of Study OTX-101-2016-001

Exclusion Criteria:

-

Primary outcomes:
measure: Adverse Events
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sheppard J, Bergmann M, Schechter BA, Luchs J, Ogundele A, Karpecki P. Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca. Clin Ophthalmol. 2021 Jan 12;15:129-140. doi: 10.2147/OPTH.S279364. eCollection 2021.
Clinical trial NCT05115474: Study of Screening Brain MRIs in Stage IV Breast Cancer
Official title: Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Triple Negative Breast Cancer
HER2-positive Breast Cancer
Hormone Receptor-positive Breast Cancer
Keywords: Stage IV Breast Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Florida Breast Cancer Foundation
First posted: 2021-11-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage IV breast cancer patients at Moffitt Cancer Center

Brief summary: The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
* Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+/HER2- patients
* Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients
* Age ≥ 18
* Life expectancy ≥ 6 months
* Eastern Cooperative Oncology Group performance status 0 to 2
* Patients must be able to understand and the willingness to sign an informed consent for study procedures
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Prior diagnosis or treatment of brain metastases or leptomeningeal disease
* Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years
* Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
* Indications warranting brain MRI for other neurologic conditions at time of study entry
* Contraindication towards MRI imaging with contrast
* Chronic kidney disease stage IV or V or end stage renal disease

Primary outcomes:
measure: Rate of Brain Metastasis
timeFrame: at Baseline
measure: Rate of Brain Metastasis
timeFrame: up to 6 months
Secondary outcomes:
measure: Rate of Asymptomatic Leptomeningeal Disease
timeFrame: Baseline and at up to 6 months
measure: Number of Brain Metastases
timeFrame: Baseline
measure: Overall Survival
timeFrame: Up to 6 months
measure: Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation
timeFrame: Up to 6 months
measure: Brain Metastasis Specific Survival
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Morton Plant Mease- Baycare
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Kamran A Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03278574: Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease
Official title: Mitral Valve Repair Using Flexible Bands Versus Complete Rings in Patients With Degenerative Mitral Valve Disease: a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2017-09-11
Enrollment: 171
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 study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease

Detailed description: Currently, mitral ring selection is based on a surgeon's preference rather than evidence. Semirigid rings combine flexibility and stability; however, their clinical benefit has not been completely clarified. The present study aimed to compare the outcomes of mitral valve repair with a flexible posterior annuloplasty band versus complete semirigid ring in patients with degenerative mitral valve disease.

Eligibility criteria: Inclusion Criteria:

* severe primary mitral regurgitation due to degenerative mitral valve disease

Exclusion Criteria:

* previous open cardiac surgery,
* indication for concomitant aortic valve replacement,
* left ventricle impairment (ejection fraction \< 40%).

Primary outcomes:
measure: Freedom from significant mitral regurgitation
timeFrame: 12 months
Secondary outcomes:
measure: Survival
timeFrame: 12 months, 24 months
measure: Freedom from reoperations
timeFrame: 12 months, 24 months
measure: Freedom from severe MR recurrence
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Bogachev-Prokophiev AV, Afanasyev AV, Zheleznev SI, Nazarov VM, Sharifulin RM, Karaskov AM. Mid-term results of mitral valve repair using flexible bands versus complete rings in patients with degenerative mitral valve disease: a prospective, randomized study. J Cardiothorac Surg. 2017 Dec 13;12(1):113. doi: 10.1186/s13019-017-0679-0.
Clinical trial NCT01852474: Effects of Transcranial Direct Current Stimulation (tDCS) and Motor Learning in Children With Cerebral Palsy (CP)
Official title: Effects of tDCS in Cortical Plasticity and Motor Learning in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: motor learning
cortical plasticity
direct current stimulation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Pedal with Pete
First posted: 2013-05-13
Enrollment: 5
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the investigators aim to assess the clinical and neurophysiological effects of a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)- on cortical plasticity and motor learning in children with cerebral palsy. Investigators will use different assessment techniques, such as transcranial magnetic stimulation (TMS) and kinematics (sensors) to measure changes through the trial.


Eligibility criteria: Inclusion Criteria:

* Age of participants must be between 8 and 18 years old.
* Diagnosis of spastic or mixed CP with distribution of diplegia and/or hemiplegia form.
* Gross Motor Function Classification System for Cerebral Palsy (GMFCS) level II and III.
* Manual Ability Classification System for Children with CP (MACS) level II up to IV.
* Ability to cooperate and follow directions.

Exclusion Criteria:

* Muscle tone reduction therapy in the past 3 months prior to study onset.
* Upper limb orthopedic surgery in the past 3 months prior to study onset.
* Any other form of therapy or procedure involving motor neuron junction inhibition; either by biochemical and/or mechanical denervation, in the past 3 months prior to study onset.
* History of convulsive disorder in the past 2 years prior to study onset.
* Current use of carbamazepine as anticonvulsive therapy.
* Presence ventriculoperitoneal shunt.

Primary outcomes:
measure: Changes in motor assessments
timeFrame: Approximately 2 weeks
Secondary outcomes:
measure: Changes in TMS measurements
timeFrame: Approximately 2 weeks
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Network Research Institute
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06821074: Defocus-Enhanced vs. Single Vision Spectacles in Myopia Control Visual Function Training
Official title: Comparative Study of Visual Function Training With Defocus-Enhanced Spectacles vs. Single Vision Spectacles on Myopia Control in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: myopia
Visual Function Training
Defocus-Enhanced Spectacles
Single Vision Spectacles
Lead sponsor: Beijing Visionly Plus Eye Hospital
Sponsor class: OTHER
Collaborators: name: High Myopia Control Alliance (HIMALAYA)
name: Beijing New Vision Eye Hospital
First posted: 2025-02-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of vision function training using defocus-enhanced spectacles (DIMS) versus single vision spectacles combined with vision function training in controlling myopia progression in children aged 6-18 years.


Eligibility criteria: Inclusion Criteria:

* Aged 6-18 years.
* Diagnosed myopia with SER between -0.50D and -4.00D.
* Astigmatism ≤ 2.50DC.
* Anisometropia \< 1.25D.

Exclusion Criteria:

* Suspected genetic syndromes (e.g., Stickler, Marfan).
* Other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus).
* Myopia progression \<0.50D SER in the last year.

Primary outcomes:
measure: Change in spherical equivalent 12 months after the commencement of training.
timeFrame: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.
Secondary outcomes:
measure: Change in axial length 12 months after the commencement of training.
timeFrame: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing New Vision Eye Hospital
city: Beijing
country: China
facility: Beijing Visionly Plus Eye Hospital
Study officials:
References:
Clinical trial NCT01575574: Magnetic Resonance With Gadoxetic Acid for the Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis. Evaluation of Its Impact for the Non-invasive Diagnosis
Official title: Magnetic Resonance With Gadoxetic Acid for the Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis. Evaluation of Its Impact for the Non-invasive Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of hepatocellular carcinoma

Detailed description: The investigators plan to define the imaging patterns of hepatocellular carcinoma in cirrhotic patients when studied with gadoxetic acid magnetic resonance imaging including the dynamic phase and the hepatobiliary phase at 10 and 20 minutes after contrast injection and to evaluate the usefulness of liver magnetic resonance imaging with gadoxetic acid in the differentiation between benign and malignant nodules in the cirrhotic liver. To determine the diagnosis and clinical significance of the infracentimetric additional nodules detected in the hepatobiliary phase

Eligibility criteria: Inclusion Criteria:

* more than 18 years old
* patient with diagnosis of liver cirrhosis Child Pugh A-B
* Patients without previous hepatocellular carcinoma in whom ultrasound detects a suspicious hepatic lesion; solitary solid and well-defined nodule between 10 and 20mm
* patients in whom diagnosis of hepatocellular carcinoma is a clinical need prior to treatment indication
* patient that agree to participate signing informed consent form

Exclusion Criteria:

* Patients with poor liver function who would have undergone transplantation even without hepatocellular carcinoma diagnosis (Child-Pugh C)
* patients with previous diagnosis of hepatocellular carcinoma
* patients with significant comorbidities that could prevent the optimum therapeutic decision in case of positive diagnosis of hepatocellular carcinoma
* patients with severe clotting alterations that contraindicate the fine-needle biopsy -Patients with chronic kidney disease or glomerular filtration rate \< 30 ml/min
* patients with contraindications to perform magnetic resonance imaging (pacemaker, claustrophobia...)
* Known hypersensitivity to study drugs or excipients
* pregnancy or breastfeeding

Primary outcomes:
measure: hepatocellular carcinoma diagnosed
timeFrame: 1 month
Secondary outcomes:
measure: magnetic resonance imaging sensitivity
timeFrame: 9 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Hospital Clínic of Barcelona
name: Carmen Ayuso, Prof, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02453074: Automated System for Gathering and Reporting Clinical Outcomes to Providers
Official title: Automated System for Gathering and Reporting Clinical Outcomes to Providers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ambulatory Care
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
First posted: 2015-05-25
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of two primary clinics at Massachusetts General Hospital, Boston MA

Brief summary: The purpose of this study is to design and test the feasibility of a system to survey patients regarding the outcome of acute care visits and to report back to the healthcare providers.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 and older visiting participating primary care clinics who agree to be contacted by email to complete a survey on clinical outcomes.

Exclusion Criteria:

* None

Primary outcomes:
measure: Survey response rate
timeFrame: Assessed at the end of the 12 week study period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05999474: Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial
Official title: Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Onychomycosis of Fingernail
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim is to assess the clinical efficacy and the safety of fractional CO2 laser combined with topical tioconazole versus Q-switched Nd:YAG laser in the treatment of OM.


Eligibility criteria: Inclusion Criteria:

* • Age group \>18 years.

  * Patients of both genders.
  * Patients with OM any type.

Exclusion Criteria:

* • Pregnancy

  * Localized bacterial infection around the affected nail
  * Concomitant nails disease that causes nail dystrophy or discoloration such as psoriasis, lichen planus and atopic dermatitis that may interfere with diagnosis and treatment
  * Hypersensitivity to terbinafine
  * Intake of oral antifungal medication within the last 3 months or used topical antifungal medication within the last 2 weeks prior to the laser treatment

Primary outcomes:
measure: treatment of onychomycosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy Faculty of Medicine
Study officials:
References: