louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06772090: Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies
Official title: A Randomized Placebo-controlled Feasibility Trial of Probiotic Supplementation During Adjuvant or Neoadjuvant Cytotoxic Chemotherapy for Solid Tumor Malignancies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Solid Tumor, Adult
Cytotoxicity
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot single-blind placebo-controlled randomized trial to establish experimental feasibility. We plan on enrolling a pilot cohort of 40 patients, with up to 5 patients in treatment phase 0 and the remaining in treatment phase I. During Phase I, the remaining participants will be assigned to either treatment or control group using dynamic block randomization balancing on sex, age group, and disease histology.


Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years old
* Diagnosis of stage III colon cancer
* Undergoing chemotherapeutic treatment within the MHFV or MVAHC medical systems.

Exclusion Criteria:

* Allergy or sensitivity to probiotic supplementation
* Diagnosis/history of:

Non-colon GI cancer or chronic GI-related disease or disorders such as gastric ulcer, irritable bowel syndrome, inflammatory bowel disease, or intestinal malabsorption syndrome Cognitive impairment, such as dementia, or developmental disorder that would affect ability to give consent or comply with study procedures

* Current treatment of cancer other than non-melanoma skin cancer, including metastases and recurrences
* Current participation in another interventional study of medication(s)
* Major changes in eating habits within the past 3 months, such as stopping or starting a restricted diet
* BMI ≥40 kg/m2 or ≤17 kg/m2
* Unexpected change in weight of ˃4.5 kg within the past 6 months

Primary outcomes:
measure: Number of Participants at end of study
timeFrame: Week 12
Secondary outcomes:
measure: Number of Adverse Events related to Cytotoxic Chemotherapy
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01040390: Efficacy of Lappa Arctium (Homoeopathic Medicine) in Treatment of Acne Vulgaris
Official title: Efficacy of Lesser Known Homoeopathic Medicines in Acne Vulgaris - Lappa Arctium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Homoeopathy
Lappa Arctium
Lead sponsor: Miglani, Anjali
Sponsor class: INDIV
Collaborators: name: Department of Indian Systems of Medicine and Homeopathy
First posted: 2009-12-29
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acne is one of the most common skin problems in teenagers and adolescents. There are many lesser known homoeopathic medicines which have been mentioned in the literature for treatment of acne but their potential has not been properly assessed /documented and therefore these medicines don't form a part of many prescriptions. As a part of this study,efficacy of Lappa Arctium will be studied in the treatment of Acne vulgaris


Eligibility criteria: Inclusion Criteria:

* Males and females between 12 to 25 years of age
* Presence of inflammatory and non-inflammatory lesions
* Able to follow-up according to protocol
* Patients not taking any medication for treatment of Acne in preceding one month.

Exclusion Criteria:

* Acne Conglobata
* Pregnant or Breast feeding females or females having intention of becoming pregnant
* Significant systemic disease
* Any drug/ alcohol addiction
* History of chronic diseases treated with medications in the preceding month which might affect acne condition and treatment outcome

Primary outcomes:
measure: percent change in acne lesion counts from the Baseline
timeFrame: 6 months
Secondary outcomes:
measure: change in quality of life of subjects
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Delhi Government Health Centre - Homoeopathic Dispensary - Sector 12, Dwarka
state: Delhi
Study officials:
affiliation: Department of Indian Systems of Medicine and Homeopathy
name: Anjali Miglani, BHMS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miglani A, Manchanda RK. Observational study of Arctium lappa in the treatment of acne vulgaris. Homeopathy. 2014 Jul;103(3):203-7. doi: 10.1016/j.homp.2013.12.002.
Clinical trial NCT00987090: Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)
Official title: Early-onset and Late-onset Sporadic Alzheimer's Disease (AD) : Variations of the Clinical Profile and Paraclinical Features Depending on the Age at the Onset of Clinical Signs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Keywords: subjects developing symptoms of Alzheimer Disease
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 240
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Alzheimer's disease (AD) is usually associated with aging, age being the principal identified risk factor. However, younger subjects also develop AD and the prevalence of early onset AD is unknown. It is estimated that about 30 000 subjects develop symptoms of AD before the age of 65 in France. There is evidence that early onset AD differs from AD in older patients. In particular, clinical and neuroimaging studies suggest early involvement of neocortical brain regions and their functions in early onset AD, while mediotemporal areas and memory might be more involved in late onset AD. These differences could partly explain the atypical clinical and imaging features of younger patients, the diagnostic difficulties in these patients and the specific problems related to medical care of this age group. The present study uses a multidisciplinary approach with longitudinal followup in order to establish the impact of age on the clinical and neuroimaging picture of sporadic AD in a multicentric setting. Another aim of the project is to describe for each age group, and in particular for the younger patient group, the functional impact of disability in everyday life on both, patients and caregivers.


Eligibility criteria: Inclusion Criteria:

* Arm Alzheimer Disease : first symptoms from 1 to 5 years before the inclusion, Clinical Dementia Rating = 1, efficient contraception for women
* Arm Control : efficient contraception for women

Exclusion Criteria:

* Important general disease : diabetes, neoplasia, alcoholism
* First symptoms less than 1 year or more than 5 years before the inclusion
* Pregnancy, breast feeding

Primary outcomes:
measure: to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting.
timeFrame: 3 years
Secondary outcomes:
measure: to describe for each age group, and in particular for the younger patient group, the functional impact of disability in everyday life on both, patients and caregivers.
timeFrame: 3 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique - Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique - Hôpitaux de Marseille
name: mathieu ceccaldi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06324890: PET-CT Imaging Features of Meibomian Glands
Official title: PET-CT Imaging Features of Meibomian Glands
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MGD-Meibomian Gland Dysfunction
Positron-Emission Tomography
Dry Eye
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visited the ophthalmology Department of Zhongnan Hospital from January 2021 to December 2023 and had a PET-CT examination in the hospital within one month

Brief summary: Analysis the results of Dry eye analysis results and PET-CT imaging comprehensively

Detailed description: Medical records of patients who visited the ophthalmology department between January 2021 and December 2023 and had a PET-CT examination in our hospital within one month were collected. The dry eye analysis results of all patients were collected, and the lacrimal river height, tear film rupture time and meibomian gland grade were counted. The results of PET-CT were collected and the SUV values of the tarsal gland were calculated.

Eligibility criteria: Inclusion Criteria:

* Patients who visited the ophthalmology Department of Zhongnan Hospital from January 2021 to December 2023 and had a PET-CT examination in the hospital within one month

Exclusion Criteria:

* Dry eye analysis was not performed
* History of eye surgery or trauma
* Other systemic diseases affecting the eyes

Primary outcomes:
measure: Lacrimal river height
timeFrame: Within a month of the PET imaging
measure: Tear break-up time
timeFrame: Within a month of the PET imaging
measure: Tear-film lipid layer thickness
timeFrame: Within a month of the PET imaging
measure: Meibomian glands two-dimensional digital infrared images
timeFrame: Within a month of the PET imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT02245464: Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential Hypertension
Official title: The Post Marketing Surveillance Study Conducted With a Continuous Enrollment Method to Assess Serious Adverse Events, Adverse Events, Safety, Efficacy of Micardis Tablet (Telmisartan 20, 40, 80mg p.o. Once Daily Over 2 Weeks)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 13066
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with essential hypertension and without prior Micardis experience

Brief summary: The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years


Eligibility criteria: Inclusion Criteria:

* Male and female patients diagnosed with essential hypertension
* Patients without prior experience with Micardis tablet

Exclusion Criteria:

* Known hypersensitivity to Micardis tablet
* Pregnancy or breastfeeding
* Biliary atresia
* Severe hepatic failure patients
* Severe renal failure patients

Primary outcomes:
measure: Blood pressure reduction
timeFrame: Up to 6 years
measure: Final assessment of efficacy on a 3-point scale
timeFrame: Up to 6 years
measure: Assessment of efficacy based on subject's demographics on a two-point scale
timeFrame: Up to 6 years
measure: Number of patients with adverse events
timeFrame: Up to 6 years
measure: Incidence rate of adverse events
timeFrame: Up to 6 years
measure: Assessment of safety on a 4-point scale
timeFrame: Up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01150864: Effects of Airway Conditioning Devices on Ventilator Associated Pneumonia:a Randomized Clinical Trial
Official title: Effects of Airway Conditioning Devices on Ventilator Associated Pneumonia:a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lung Injury
Keywords: Hot water humidifier, Passive heat and moisture exchangers
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2010-06-25
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main hypothesis are:

1. Passive and Active-Passive airway conditioning devices reduce the incidence of ventilator associated pneumonia
2. Active-Passive airway conditioning devices reduce the incidence of endotracheal tube obstruction
3. Nurses' workload is reduced with Passive and Active-Passive airway conditioning devices

Detailed description: For all Three lines of the study we record Clinical Pulmonary Infection score and Airways Care Score, SOFA (Sequential Organ Failure Assessment), sedation strategy, Glasgow Coma Score and clinical data.

Eligibility criteria: Inclusion Criteria:

* Patients mechanically ventilated with PaO2/FiO2 lower than 300
* Age higher than 18 years
* Invasive mechanical ventilation
* Endotracheal intubation or tracheostomy for more than 24 hours

Exclusion Criteria:

* Non invasive ventilation
* Severe ARDS (PaO2/FiO2 lower than 100, or PaCO2 higher than 60 mmHg)
* Inefficient cough
* Head Trauma
* Spinal cervical trauma
* Chest trauma
* Pregnancy
* Expectance of poor survival within 72 hours
* Congenital airway disease
* Immunosuppression
* Supraglottic aspiration devices

Primary outcomes:
measure: Reduction of ventilator associated pneumonia
timeFrame: 2 years
Secondary outcomes:
measure: Endotracheal tube obstruction
timeFrame: 2 years
measure: nurses' workload
timeFrame: 2 years
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Ospedale di Circolo
Study officials:
affiliation: Universita' degli Studi dell'Insubria, Varese, Italy
name: Paolo Pelosi, MD
role: STUDY_DIRECTOR
affiliation: University of Insubria, Varese, Italy
name: Paolo Severgnini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01893164: Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome
Official title: Comparison of Simple Decompression Versus Anterior Subcutaneous and Intramuscular Transposition of the Ulnar Nerve for Moderate and Severe Cubital Tunnel Syndrome ：A Randomized Double-blind Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cubital Tunnel Syndrome
Keywords: cubital tunnel syndrome
simple decompression
anterior subcutaneous transposition of ulnar nerve
anterior intramuscular transposition of ulnar nerve
severity scale
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2013-07-08
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 determine which is the best surgery to treat different severity scales of cubital tunnel syndrome.

Detailed description: The purpose of this study is to determine which one of the simple decompression,anterior subcutaneous and intramuscular transposition of the ulnar nerve has the best outcomes for moderate and severe cubital tunnel syndrome.

Eligibility criteria: Inclusion Criteria:

* patients with confirmed cubital tunnel syndrome
* moderate and severe cubital tunnel syndrome.

Exclusion Criteria:

* Significant cervical spine and shoulder disease
* deformity or distortion of the cubital tunnel due to previous trauma to elbow
* recurrent cubital tunnel syndrome after previous surgery
* mild cubital tunnel syndrome.

Primary outcomes:
measure: sensation
timeFrame: at 6 months post-operatively
Secondary outcomes:
measure: Muscle strength
timeFrame: at 6 months post-operatively
measure: pain
timeFrame: at 6 months post-operatively
measure: electromyography
timeFrame: at 6 months post-operatively
Other outcomes:
Locations:
city: Changchun
country: China
facility: Hand Surgery Department of China-Japan Union Hospital
state: Jilin
Study officials:
affiliation: Hand Sugery Department of the China-Japan Union Hospital
name: Rui Li, chief doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04884464: Hyaluronic Acid in Counteracting Aphthous Stomatitis
Official title: Clinical Evaluation of a Hyaluronic Acid-based Medical Device in Counteracting Aphthous Stomatitis in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aphthous Stomatitis
Keywords: mucositis
oral ulcers
chlorhexidine
aloe barbadensis
rosa damascena
Lead sponsor: University of Urbino "Carlo Bo"
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects without ethnic limitations, of both sexes and between the ages of 18 and 65, with a diagnosis of aphthous stomatitis, but considered otherwise healthy.

Brief summary: Oral mucosal ulcers can determine a real worsening of the quality of life. Conventional therapy usually lasts not less than 2-3 weeks, and carries a high risk of serious side effects; furthermore, ulcers often recur. The use of hyaluronic acid applied as an adhesive gel over the lesions seems to have potential in terms of efficacy and the avoidance of side effects. Of course, hyaluronic acid-based formulations show different effects and tolerability. In this retrospective observational study, the results obtained using a hyaluronic-acid based medical device applied for 14 days to counteract ulcers in adults will be reported.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of aphthous stomatitis
* Healthy for other conditions excluding aphthous stomatitis

Exclusion Criteria:

* Taking one of the following in the 45 days prior to the beginning of the study: immunosuppressive, cytotoxic, cortisone, antibiotic, antifungal, hormone therapy (including birth control pills).

Primary outcomes:
measure: Change in number of oral lesions
timeFrame: Day 1; Day 3; Day 6; Day 9; Day 12; Day 14
measure: Change in size of oral lesions
timeFrame: Day 1; Day 3; Day 6; Day 9; Day 12; Day 14
Secondary outcomes:
measure: Compliance to treatment
timeFrame: From Day 1 to Day 14
measure: Side effects to treatment
timeFrame: From Day 1 to Day 14
Other outcomes:
Locations:
city: Urbino
country: Italy
facility: University fo Urbino Carlo Bo
Study officials:
affiliation: University of Urbino "Carlo Bo"
name: Davide Sisti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004464: Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
Official title: High Dose Cyclophosphamide for the Treatment of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aplastic Anemia
Paroxysmal Hemoglobinuria, Nocturnal
Keywords: aplastic anemia
hematologic disorders
paroxysmal nocturnal hemoglobinuria
rare disease
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 1999-10-19
Enrollment: 69
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose cyclophosphamide in patients with severe aplastic anemia.

II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide shortens the time to recovery in these patients.

III. Determine whether this regimen is efficacious in treating paroxysmal nocturnal hemoglobinuria.

Detailed description: PROTOCOL OUTLINE: Patients receive high dose cyclophosphamide IV on days 1-4. Beginning on day 10, patients receive filgrastim (G-CSF) until the absolute neutrophil count is greater than 1,000/mm3 for 2 consecutive days.

Patients are followed every 3 months for at least 2 years and annually thereafter.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Acquired severe aplastic anemia or paroxysmal nocturnal hemoglobinuria
* Not a candidate for allogeneic bone marrow transplantation
* Must meet one of the following criteria:

  * Severe aplastic anemia

    * Less than 25% bone marrow cellularity and depression in two of three blood counts (reticulocytes less than 40,000/mm3
    * platelet count less than 20,000/mm3 and granulocytes less than 500/mm3)
  * Life-threatening paroxysmal nocturnal hemoglobinuria

    * Absolute neutrophil count less than 500/mm3
    * platelet transfusion dependent
    * thrombotic disease
* No Fanconi anemia
* No abnormal cytogenetics

--Patient Characteristics--

* Renal: Creatinine no greater than 2.0 mg/dL
* Cardiovascular: Cardiac ejection fraction at least 45%
* Other: Not preterminal or moribund Not pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert A. Brodsky
role: STUDY_CHAIR
References:
Clinical trial NCT03623464: RCT of Mobile Apps & FitBit v. Usual Care
Official title: Randomized Clinical Trial of FitBit and Mobile Apps Versus Usual Care to Improve Post-Operative Outcomes After GI Cancer Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Gastric Cancer
Hepatic Cancer
Colon Cancer
Rectal Cancer
Small Bowel Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Damon Runyon Cancer Research Foundation
First posted: 2018-08-09
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized clinical trial to evaluate the use of mobile devices in preventing readmission in patients undergoing major GI cancer operations.

Detailed description: Patients will be randomized to 1) standard of care or 2) to use our mobile app with standard care. The mobile app will collect information on patients' daily physical activity patterns and health status data for clinicians using smartphone mobile technology applications. The investigators believe that by tracking information on patients, the investigators may be able to intervene sooner and prevent a delay in care.

Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years or older
2. Subject speaks English
3. Subject owns a smart phone
4. Subject is scheduled to undergo surgery for a GI cancer (pancreatic, hepatic, gastric, small bowel, colon, or rectal cancers)

Exclusion Criteria:

1. Physician deems the subject is unable to complete the study due to documented dementia
2. Subject is undergoing emergent surgery
3. Subject has sepsis from another source
4. Physician deems the subject is unable to complete the study due to documented alcohol and/or drug abuse

Primary outcomes:
measure: Readmission rate
timeFrame: 30 days
Secondary outcomes:
measure: Healthcare utilization rates
timeFrame: 30 days
measure: Patient Satisfaction with Device
timeFrame: 30 days
measure: Quality of life: Return to Baseline Function-Walking
timeFrame: 30 days
measure: Quality of life: Return to Baseline Function-Activities of Daily Living (ADLs)
timeFrame: 30 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine- New York Presbyterian
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Heather Yeo, MD
role: PRINCIPAL_INVESTIGATOR
References: