louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06515457: A Clinical Trial to Evaluate the Efficacy of an Oral Supplement in Supporting Vision and Eye Health
Official title: A Clinical Trial to Evaluate the Efficacy of an Oral Supplement in Supporting Vision and Eye Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation Symptoms
Eye Dryness
Eye Health
Keywords: Vision Health
Eye Empower
Lead sponsor: Bio Nature Health
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of BioNatureHealth's Eye Empower supplement in supporting vision and eye health. It is a virtual, single-group trial lasting 3 weeks. Participants will take three capsules of the supplement daily and complete questionnaires at Baseline, Week 1, Week 2, and Week 3 to assess visual clarity, dryness, symptoms of inflammation, and sensitivity to blue light.


Eligibility criteria: Inclusion Criteria:

* Male or female at birth, aged 40 or over
* Self-reported concerns about at least two of the following symptoms: dry eyes, red/itchy/irritated eyes, sensitivity to blue light, blurred vision (far or near)
* Generally healthy without uncontrolled chronic diseases
* Willing to avoid using new eye health prescriptions, over-the-counter medications, supplements, and herbal remedies for the study duration
* Consistent use of current eye health supplements or herbal remedies for at least 3 months prior to the study
* Willing to maintain current diet, sleep schedule, and activity level during the study

Exclusion Criteria:

* Pre-existing chronic conditions preventing protocol adherence, including oncological and psychiatric disorders
* Diagnosed diabetes (Type I or II)
* Planning to undergo any eye-related procedures during the study
* Recent surgeries or invasive treatments within the last six months
* History of major illness within the last three months
* Recent use of a supplement with active ingredients in the test product
* Severe allergic reactions requiring an EpiPen, including shellfish allergy
* Pregnant, breastfeeding, or planning to conceive
* Use of medications or herbal supplements that impact the blood
* Non-consumption of animal products for religious or personal reasons
* Unwillingness to follow the study protocol
* Anyone with a history of drug or alcohol abuse

Primary outcomes:
measure: Improvement in Visual Clarity
timeFrame: Baseline, Week 1, Week 2, and Week 3
measure: Reduction in Eye Dryness
timeFrame: Baseline, Week 1, Week 2, Week 3
measure: Reduction in Symptoms of Inflammation
timeFrame: Baseline, Week 1, Week 2, Week 3
measure: Reduction in Sensitivity to Blue Light
timeFrame: Baseline, Week 1, Week 2, Week 3
Secondary outcomes:
measure: Improvement in Overall Eye Health
timeFrame: Baseline, Week 1, Week 2, and Week 3
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT00171457: The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Official title: The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heartburn
Dyspepsia
Keywords: functional heartburn
dyspepsia
male
female
visceral sensitivity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach


Eligibility criteria: Inclusion Criteria:

* Male or female subjects at least 18 years of age.
* Subjects willing to undergo multiple nasogastric intubations.
* Patients with functional heartburn will need to meet ROME II criteria.
* Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characterized by bloating, postprandial fullness and early satiety)

Exclusion Criteria:

* Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant IBS.
* Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring, or previous or current history of ulcer disease.
* Subjects with Diffuse Esophageal Spasm or Achalasia.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach
Secondary outcomes:
measure: 1) Comparing effects at end of treatment compared to baseline:
measure: To verify that tegaserod modulates esophageal sensitivity to esophageal distention
measure: To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort
measure: To determine if tegaserod improves heartburn and/or regurgitation
measure: To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo
measure: Safety assessment
measure: To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Miner PB Jr, Rodriguez-Stanley S, Proskin HM, Kianifard F, Bottoli I. Tegaserod in patients with mechanical sensitivity and overlapping symptoms of functional heartburn and functional dyspepsia. Curr Med Res Opin. 2008 Aug;24(8):2159-72. doi: 10.1185/03007990802222832. Epub 2008 Jun 17.
Clinical trial NCT03004157: Infant Chest Compression
Official title: A Randomized Comparison of Three Chest Compression Techniques and Associated Hemodynamic Effect During Infant CPR: a Randomized Manikin Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Arrest
Keywords: infant
cardiopulmonary resuscitation
hemodynamics
chest compressions
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Jacek Smereka
name: Antonio Rodríguez-Núñez
name: Jerzy R Ladny
name: Steve Leung
name: Kurt Ruetzler
First posted: 2016-12-28
Enrollment: 42
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs in the United States annually. Only 8% of the patients survive to hospital discharge and of these, up to two-thirds have neurological sequelae. Majority of pediatric cardiac arrest are below age of two and have poorer chance of survival versus older children


Eligibility criteria: Inclusion Criteria:

* active paramedics
* voluntary consent

Exclusion Criteria:

* pregnancy
* back pain
* wrist pain

Primary outcomes:
measure: systolic blood pressure
timeFrame: 1 day
Secondary outcomes:
measure: diastolic blood pressure
timeFrame: 1 day
measure: mean arterial pressure
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Department of Emergency Medicine
state: Masovia
Study officials:
References:
Clinical trial NCT02768857: Effects of Early Sensory Reeducation Programs Using Mirror Therapy for Patients With Peripheral Nerve Injuries
Official title: A Touch-Observation and Task-based Mirror Therapy Protocol (MTPTOT) to Improve Sensorimotor Control and Functional Capability of Hands for Patients With Peripheral Nerve Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensation Disorders
Motor Deficit
Rehabilitation
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the effects of an integrated program of touch-observation and task-based mirror therapy on sensorimotor function in nerve injury patients. Before the return of protective sense (Value of Semmes-Weinstein monofilament test \> 4.31), half of the participants received 15 minutes of mirror therapy program, followed by 20 minutes of regular hand therapy and 20 minutes of physiotherapy.While the other half received 15 minutes protective sensory reeducation programs, 20 minutes of regular hand therapy and 20 minutes of physiotherapy in each treatment session. Once the patients had regained the protective sense (Value of Semmes-Weinstein monofilament test \< 4.31), the discriminative sensory reeducation program was started for the participants in both groups. The hypothesis was that using the mirror therapy for sensorimotor reeducation in the early phase after nerve repair would yield better results with regard to the returning of sensation, sensorimotor control ability and hand function than using a classical reeducation program alone.


Eligibility criteria: Inclusion Criteria:

* median or ulnar nerve injury,
* a combination of nerve and tendon or vascular injury,
* injury sites between the level of mid-palm and elbow, and
* the protective sensation of the hand is lacking or impaired.

Exclusion Criteria:

* patients with deficits in cognition or language comprehension, as well as severe limitations in the range of motion of the upper limbs.

Primary outcomes:
measure: Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks and 24 weeks
timeFrame: baseline, 12 weeks and 24 weeks
measure: Change from baseline result of Purdue pegboard test at 12 weeks and 24 weeks
timeFrame: baseline, 12 weeks and 24 weeks
measure: Change from baseline result of Minnesota manual dexterity test at 12 weeks and 24 weeks
timeFrame: baseline, 12 weeks and 24 weeks
measure: Change from baseline result of Pinch-holding-up-activity (PHUA) test at 12 weeks and 24 weeks
timeFrame: baseline, 12 weeks and 24 weeks
Secondary outcomes:
measure: Change from baseline result of Static two-point discrimination (S2PD) test at 12 weeks and 24 weeks
timeFrame: baseline, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References:
Clinical trial NCT05780957: Multi-Cancer Early Detection (MCED) of Firefighters
Official title: Multi-Cancer Early Detection (MCED) of Firefighters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Cancer
Multi-Cancer Early Detection
MCED
Lead sponsor: Vincere Cancer Center
Sponsor class: OTHER
Collaborators: name: Elypta
First posted: 2023-03-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Actively working firefighters of any adult age, any gender and any demographic group are eligible, as well as no limitations regarding general health status other than those specified in the protocol Eligibility Criteria.

Brief summary: This study is an an observational prospective cohort research study to explore the performance of new blood and urine tests for the early detection of cancer among firefighters.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Currently employed as a firefighter, full-time or part-time
* Taking part in Vincere's First Responder Cancer Screening Program
* Able to donate blood and urine sample
* Able to provide informed consent to participate in the study

Exclusion Criteria:

* Deemed medically unfit for sample donation
* Personal history of cancer in the last 5 years (with the exception of non-melanoma skin cancer)

Primary outcomes:
measure: Sensitivity, specificity, positive and negative predictive performance values (PPV and NPV) to detect cancer using Elypta's MCED test, as measured in plasma, in urine, and in plasma and urine combined
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Vincere Cancer Center
state: Arizona
Study officials:
affiliation: Vincere Cancer Center
name: Vershalee Shukla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04963257: Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder
Official title: A Randomized Controlled Trial of Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: OCD
Keywords: sertraline
OCD
fluvoxamine
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To verify that sertraline combined with fluvoxamine is superior to sertraline combined with aripiprazole

Detailed description: To verify that sertraline combined with fluvoxamine is superior to sertraline combined with aripiprazole, and to observe the indicators of improving patients' cognitive function and adverse drug reactions, so as to provide evidence-based evidence for supplementing the treatment guidelines for obsessive-compulsive disorder

Eligibility criteria: Inclusion Criteria:

* The Diagnostic criteria of OCD in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V), as well as the definition of refractory OCD, are as follows: failure to respond to oral treatment with at least two effective doses of antidepressants, including: Fluoxetine (≥20mg/ d), fluvoxamine (≥200mg/d), sertraline (≥150mg/d), and paroxetine (≥ 40mg/d) were all treated for at least 12 weeks. The Yale-Brown compulsive scale (Y-BOCS) score decreased by \< 35%.
* The total score of Yale- Brown compulsion scale (Y-BOCS) ≥16 points. (3)age 12 \~ 45 years.

Exclusion Criteria:

* Exclusion of severe organic brain disease;
* Severe physical illness;
* Other mental disorders such as tics, disruptive disorders, eating disorders and autism spectrum disorders;
* Pediatric streptococcal infection causedby autoimmune neuropsychiatric disease (PANDAS);
* Alcohol and drug dependence; Angle-closure glaucoma;
* Suicidal tendencies;
* Previous history of drug allergies related to research;
* Pregnant and lactating women.

Primary outcomes:
measure: Y-BOCS score
timeFrame: 12 weeks
measure: Ratio of Y-BOCS score reduction from baseline
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital of Zhejiang University Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT06599957: Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy
Official title: Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone and Soft Tissue Tumors
Keywords: sarcomas
nanocarriers
therapy
nanophotonic
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: Università Degli Studi del Sannio Dipartimento di Ingegneria Benevento
name: IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola
First posted: 2024-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by sarcoma and undergoing surgical removal of the tumor or performing a biopsy will be enrolled. Only patients whose resection will provide sufficient tumor tissue that exceed what is necessary for pathological diagnosis characterization and banking will be enrolled.

Brief summary: DEEPLY aims to improve sarcoma therapy by the development of an innovative nanophotonic delivery approach to be applied in the future as an integrated local therapy for patients with inoperable tumors or with oligometastases. The major aim of the project is the development of innovative nanocarriers loaded with chemotherapeutic agents, whose delivery will be improved by the use of an optic fiber (optoporation). After the synthesis, and characterization of NPs, a prototype will be produced and preclinically validated on patient-derived biological material. This wide comprehensive methodological approach will ensure the obtainment of robust data to be faster exploited toward clinical applications.


Eligibility criteria: Inclusion Criteria:

* Patients eligible for the study will be male or female, with an age ranging from 0- to 85 years, undergoing surgery or biopsy for STSs or BSs including osteosarcomas.
* Included patients may have undergone or may be still in treatment with chemotherapy (also neo-adjuvant settings), targeted therapy, radiotherapy, or combination therapy.
* IRST will enroll only adult patients (age \&gt; 18 years).
* Signed informed consent from all subjects enrolled in the study. IOR patients will have to sign both the specific project Informed Consent and the IOR Biobank Informed consent.

Exclusion Criteria:

* Patients not affected by STSs or BSs will be excluded from the study, as well as patients with multiple primary tumors.

Primary outcomes:
measure: Primary Objective
timeFrame: 2 years
Secondary outcomes:
measure: Secondary Objectives
timeFrame: 2 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli-OSOTT
state: Emilia-Romagna
city: Meldola
country: Italy
facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
state: Emilia-Romagna
Study officials:
References:
Clinical trial NCT00691457: Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina
Official title: Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Solution
Keywords: Contact lens
solution
confocal microscope
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 15
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: Three arm study comparing three novel contact lens solutions.


Eligibility criteria: Inclusion:

* Stable distance contact lens prescription between -0.50 D and 9.00 D and astigmatism less than or equal to -1.00 D cylindrical (cyl).
* Stable correction is defined as longer than six months.
* Worn a single brand of disposable silicone hydrogel contact lenses successfully (i.e., without complications or discomfort) for a minimum of six months

Exclusion:

* Known sensitivity to the contact lens disinfecting solutions or fluorescein dye.
* Any systemic or ocular disease that could affect contact lens wear.
* Women who are pregnant or lactating.

Primary outcomes:
measure: Change from baseline in corneal fluorescein staining as evaluated at Day 30
timeFrame: 30 Days
Secondary outcomes:
measure: Confocal evaluation variables as measured at Days 0, 14, and 30
timeFrame: Day 0, 14, 30
Other outcomes:
Locations:
city: Virginia Beach
country: United States
facility: Virginia Beach, VA
state: Virginia
Study officials:
References:
Clinical trial NCT02498457: The Effects and Safety of Low Calcium Dialysis on Coronary Artery Calcification in Maintenance Hemodialysis Patients
Official title: The First Affiliated Hospital of Chongqing Medical University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Calcification
Keywords: maintenance hemodialysis patients
coronary artery calcification
low calcium dialysate
effects
safety
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aim to observe the preventive effect and the long term safety of low calcium dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients.

Detailed description: MHD patients recruited in this study were randomly divided into two groups: routine dialysis group (with dialysate calcium concentration 1.5mmol/L) and low calcium dialysis group (with dialysate calcium concentration 1.25mmol/L). All patients were dialyzed thrice weekly for 4 hours with a bicarbonate-based solution. They were followed up in every dialysis interview during the 1-year study, the occurrence of all adverse reactions associated with dialysis were recorded during the study. All patients received heart spiral CT examination before and at the end of the study. Coronary artery calcification was assessed by a certain professional who was not affiliated to the dialysis center.

Eligibility criteria: Inclusion Criteria:

* Maintenance hemodialysis (MHD) patients who dialyze thrice weekly in our hospital with serum iPTH \<500pg/ml, adjusted serum calcium≧8.4mg/dl in two serial tests.
* Patients who have no chronic infection or malignant tumour and with relatively stable heart and lung function.
* Patients who signed informed consent documents at the time of enrollment in the study.

Exclusion Criteria:

* Patients whose heart or lung function are poor, or with unstable hemodynamics.
* Patients who are diagnosed active pulmonary tuberculosis, AIDS, malignant tumour, or decompensated liver cirrhosis.
* Patients who are unable or unwilling to cooperate with the researchers in the treatment and follow-up.

Primary outcomes:
measure: Changes in coronary artery calcification after 1 year's treatment
timeFrame: 1 year
Secondary outcomes:
measure: The intolerance of low calcium dialysis because of adverse reactions associated with dialysis were recorded during the study
timeFrame: 1 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Hua Gan, Dr.
role: STUDY_DIRECTOR
References: