louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06548256: The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease
Official title: The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clostridium Butyricum Miyairi
Parkinson Disease
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Drug: Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year Drug: observed for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year
Primary purpose: TREATMENT

Brief summary: This is an open-label, single-center, non-randomized study to assess the efficacy of Clostridium Butyricum Miyairi on the motor and non-motor symptoms of Parkinson's disease

Detailed description: The physician will explain the trial procedures in the outpatient, and then obtain the written informed consent to start the interview. And randomly divided into experimental and observation groups, and according to the timing of taking Miyarisan, scale evaluation and sample collection.

Eligibility criteria: Inclusion Criteria:

* Male or female over 20 years old, diagnosed with Parkinson's disease.

Exclusion Criteria:

* People with Parkinson's disease Dementia, or Lactose Intolerance

Primary outcomes:
measure: MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
timeFrame: 0, 3, 12, 15, 24 months
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: 0, 3, 12, 15, 24 months
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: 0, 3, 12, 15, 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung city
country: Taiwan
facility: Kaohsiung Medical Univeristy Hospital
Study officials:
References:
Clinical trial NCT06069856: Multiple Micronutrient Supplementation (MMS) Vs IFA Acceptability Crossover Trial
Official title: Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Versus IFA During Pregnancy in Tanzania
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Pregnancy Related
Keywords: Acceptability
Multiple Micronutrient Supplementation
Iron
IFA
Tanzania
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Ifakara Health Institute
name: Harvard School of Public Health (HSPH)
name: Muhimbili University of Health and Allied Sciences
name: Africa Academy for Public Health
name: Columbia University
First posted: 2023-10-06
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is an individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.


Eligibility criteria: Inclusion Criteria:

* Attending first ANC visit at the study clinic
* Pregnant women ≤ 15 weeks of gestation
* Aged ≥ 18 years
* Intending to stay in the study area for the duration of study
* Provides informed consent

Exclusion Criteria:

* Severe anemia (defined as Hb \<8.5 g/dL per Tanzania standard of care)
* Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
* Concurrent participation in other nutritional supplementation trial

Primary outcomes:
measure: Acceptability of formulation
timeFrame: At two months of taking each regimen
Secondary outcomes:
measure: Most preferred formulation
timeFrame: At four months (after taking both regimens)
measure: Side Effects of formulation
timeFrame: At two months of taking each regimen
measure: Adherence
timeFrame: At two months of taking each regimen
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Blair Wylie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ifakara Health Institute
name: Honorati Masanja, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Africa Academy of Public Health
name: Alfa Muhihi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili University of Health and Allied Sciences
name: Andrea Pembe, MD, MMed, PhD, FCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Washington University
name: Emily R Smith, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Christopher R Sudfeld, ScD, ScM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05053256: The Relationship Between Heart Function and Metabolism in HFpEF Patients
Official title: The Relationship Between Heart Function and Metabolism in Heart Failure With Preserved Ejection Fraction Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients with preserved ejection fraction (HFpEF)

Brief summary: HFpEF has gradually become the most common form of heart failure. Studies have found that metabolic abnormalities and chronic inflammation ultimately lead to HFpEF by promoting heart remodeling. However, there are few relevant studies and the mechanism is still unclear.

Detailed description: However, heart failure with preserved ejection fraction is difficult to diagnose and treat due to its unknown pathogenesis and poor prognosis. Ventricular diastolic dysfunction and retention of left ventricular ejection fraction are important pathological features of Heart failure with preserved ejection fraction. Currently, it is widely believed to be a clinical syndrome associated with old age, women, obesity, diabetes, hypertension, atrial fibrillation, coronary heart disease, atherosclerosis, etc. However, the specific mechanism of heart failure with preserved ejection fraction caused by the above-mentioned complications is unknown. In conclusion, the investigators intend to explore the pathogenesis of heart failure with preserved ejection fraction by observing the changes of heart and body metabolism in patients with heart failure with preserved ejection fraction, and provide a basis for the diagnosis and treatment.

Eligibility criteria: Inclusion Criteria:

* Adult aged ≥ 18 years old
* Patients diagnosed with HFpEF;

Diagnostic criteria including:

1. LVEF 50% or higher;
2. BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
3. Presence of symptoms and/or signs of heart failure;
4. At least one additional criteria: relevant structure heart disease or diastolic dysfunction

Exclusion Criteria:

* Severe liver failure;
* Other causes of shortness of breath, such as severe pulmonary disease or severe ● chronic obstructive pulmonary disease;
* Primary pulmonary hypertension.
* Severe left valvular heart disease.
* Long-term bedridden or unable to move autonomously
* Age \< 18

Primary outcomes:
measure: Muscle mass
timeFrame: On admission
measure: Blood uric acid
timeFrame: On admission
measure: Body fat content
timeFrame: On admission
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Dongying Zhang, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00864656: Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 10% Phenylephrine
Official title: Comparative Study of Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 1, 2 or 4 Drops of 10% Phenylephrine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blepharoptosis
Keywords: adrenergic alpha-agonists
phenylephrine
drug effects
diagnostic use
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-03-19
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Involutional blepharoptosis patients

Brief summary: The primary aim of this study is to quantify eyelid position changes in tested and opposite eyes in ptosis patients submitted to 1, 2 or 4 drops of 10% phenylephrine in one eye. The secondary objective is to correlate the eye dominance, severity and laterality of ptosis with eyelid position changes in these 3 groups.

Detailed description: This is a prospective observational study conducted in involutional ptosis patients, which will be submitted to instillation of a single drop of 10% phenylephrine in one eye(Group 1), 2 drops (G2) or 4 drops ( G3).

Video camera will record the images of both eyes before and after drug application at 3, 10, 15 and 30 minutes. The images will be edited to analyze upper and lower lid height.

Eligibility criteria: Inclusion Criteria:

* Involutional blepharoptosis
* Upper Margin-reflex distance less or equal 2.0mm
* Good fixation and collaboration

Exclusion Criteria:

* Previous eyelid surgeries
* Use of adrenergic or sympathicomimetics drugs
* Myopathies
* Thyroid orbitopathy
* Non-controlled cardiovascular disease

Primary outcomes:
measure: Upper lid height before and after phenylephrine test lower lid height before and after phenylephrine test
timeFrame: 3, 10, 15 and 30 minutes
Secondary outcomes:
measure: Scobee test to detect eye dominance
timeFrame: 15 minutes before 10% phenylephrine instillation
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Ophthalmology Dept. University of Sao Paulo General Hospital
Study officials:
affiliation: Opthalmology Dept.Sao Paulo University General Hospital
name: Suzana Matayoshi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nunes TP, Matayoshi S. [Phenylephrine 10% eye drop action in the eyelid position in healthy subjects]. Arq Bras Oftalmol. 2008 Sep-Oct;71(5):639-43. doi: 10.1590/s0004-27492008000500006. Portuguese.
Clinical trial NCT02230956: BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
Official title: BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 176
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.


Eligibility criteria: Inclusion Criteria:

* Painful osteoarthritis
* Able to discontinue anti-inflammatory drugs and analgesics
* Must be ambulatory without assistive walking devices

Exclusion Criteria:

* Chronic pain conditions other than knee osteoarthritis
* Treatment with corticosteroids in the study knee within 12 weeks
* Treatment with hyaluronic acid in the study knee within 24 weeks
* Previous treatment with any botulinum toxin for any reason
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

Primary outcomes:
measure: Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale
timeFrame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
measure: Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale
timeFrame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
measure: Patient Global Impression of Change (GIC) Using a 7-Point Scale
timeFrame: Weeks 1, 4, 8, 12, 16, 20 and 24
measure: Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Pardubice
country: Czechia
city: Vejle
country: Denmark
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: McAlindon TE, Schmidt U, Bugarin D, Abrams S, Geib T, DeGryse RE, Kim K, Schnitzer TJ. Efficacy and safety of single-dose onabotulinumtoxinA in the treatment of symptoms of osteoarthritis of the knee: results of a placebo-controlled, double-blind study. Osteoarthritis Cartilage. 2018 Oct;26(10):1291-1299. doi: 10.1016/j.joca.2018.05.001. Epub 2018 May 9.
Clinical trial NCT01658956: Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia
Official title: A Phase II Randomized Study to Verify the Papaldo's Hypothesis : the Effectiveness of a Reduced Dosing of G-CSF in Chemotherapy-treated Patients With a Low to Moderate Risk of Febrile Neutropenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: GCSF
Chemotherapy
Breast cancer
Prophylaxis
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 142
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.


Eligibility criteria: Inclusion Criteria:

Breast cancer Chemotherapy administration (new line) Chemotherapy type : FEC, EC, AC, docetaxel containing regimen Chemotherapy setting : adjuvant or neoadjuvant

Exclusion Criteria:

Eligibility to receive reimbursed GCSF

Primary outcomes:
measure: Occurrence of a febrile neutropenic episode defined as fever (>=38.5°C once or >=38°C twice within 12 hours interval) and neutropenia (ANC < 0.5 IU)
timeFrame: At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization
Secondary outcomes:
measure: Need for unplanned hospitalization
timeFrame: At the beginning of second chemotherapy cycle, no more than 30 days after randomization
measure: Complicated febrile neutropenic episode
timeFrame: At the beginning of the second chemotherapy cycle, no more than 30 days after randomization
measure: Mortality any cause
timeFrame: 30 days from randomization
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
References:
Clinical trial NCT06632756: Positive Psychology for Smoking Cessation
Official title: Positive Psychotherapy for Smoking Cessation: a Focus on Strengths to Improve Self-efficacy and Enable Successful Quitting Strategies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Illness
Tobacco Dependence
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine how Positive Psychotherapy (PPT) may help people interested in quitting smoking, quit.

Detailed description: This project aims to adapt the Positive Psychotherapy (PPT) practice for smoking cessation in adults with severe mental illness (SMI), testing its usability, feasibility, and acceptability in a mixed-methods feasibility pilot study. Qualitative interviews will be conducted to obtain usability and acceptability input on the adapted PPT manual from 4-5 Peer Providers. Then, in partnership with The Mental Health Center of Greater Manchester (MHCGM), 6-8 adult smokers with SMI will be recruited who want to quit smoking in the next month and are willing to use nicotine replacement therapy (NRT). The 16-week PPT adaptation ("Positive Recovery for Smoking") will be tested progress on cessation assessed through interviewer-administered quantitative assessments at baseline, 8, and 16 weeks. Self-reported cigarettes per day (CPD) and carbon monoxide (CO) will be collected prior to each group treatment session. Informed by the weekly group check-in of cessation progress (quitting status), qualitative interviews will be conducted at 16 weeks to obtain a more nuanced description of the uptake of the intervention, successful quitting strategies, and barriers to cessation with this new method. The manual and materials will be adapted based on the feedback from the first group and another group of 6-8 participants will be recruited to receive the refined intervention and protocol. The result of this feasibility pilot will provide data on the adapted PPT's feasibility and acceptability, alongside a deep description of strategies used and why and how the treatment was perceived as useful or not to the enrolled participants.

Eligibility criteria: Inclusion Criteria:

* age 21+;
* Serious Mental Illness (SMI) diagnosis;
* smoking ≥10 CPD;
* breath CO ≥10;
* desire to quit in the next month;
* willingness to use NRT daily;
* English speaking and literate to engage in the treatment.

Exclusion Criteria:

* legal guardian;
* active substance use disorder.

Primary outcomes:
measure: Abstinence from Smoking
timeFrame: baseline to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United States
facility: The Mental Health Center of Greater Manchester
state: New Hampshire
Study officials:
References:
Clinical trial NCT03295656: Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis
Official title: Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Appendicitis Acute
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of acute appendicitis in children compared to conventional ultrasound.

Detailed description: Acute appendicitis is the most common surgical emergency in children. Diagnostic evaluation for possible appendicitis frequently leads to imaging studies. Magnetic resonance imaging (MRI) and computed tomography (CT) are currently the gold-standard techniques for the diagnosis or exclusion of acute appendicitis. However, these methods not always immediately available; may require administration of intravenous contrast material with the potential for allergic reactions and nephrotoxicity; and, in the case of CT, requires the administration of ionizing radiation that is linked to the long-term development of radiation-induced cancers. The current study will evaluate a potentially safer, radiation-free diagnostic method for acute appendicitis, using contrast-enhanced ultrasound to provide a more accurate means of visualizing the appendix than conventional US imaging.

Eligibility criteria: Inclusion Criteria:

* Children who have had a conventional abdominal US study to rule out acute appendicitis and are scheduled for an MRI or CT examination.

Exclusion Criteria:

* Children with serious comorbid conditions, including but not restricted to severe cardiac, pulmonary, renal, or hepatic disease; prior bone marrow or solid organ transplant; cancer; or presence of a ventriculoperitoneal shunt.
* Children with an allergy to either the active or inactive components of Lumason.
* Pregnant or nursing patients.

Primary outcomes:
measure: Contrast-enhanced ultrasound diagnosis of acute appendicitis
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Harriet Paltiel, MDCM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06964256: Clinical Trial of Abdominal Breathing for Urinary Retention After Spinal Cord Injury
Official title: Evaluation of the Efficacy and Safety of sEMG Monitoring of Lower Abdominal Breathing Training in the Treatment of Urinary Retention After Spinal Cord Injury: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries (SCI)
Urinary Retention
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trials were conducted in patients with urinary retention after spinal cord injury. The effects of abdominal breathing training on pelvic floor muscle tone, muscle strength and residual urine volume in patients with urinary retention after spinal cord injury were observed by Glazer and bladder volume measurement to compare the electromyography value and residual urine volume of pelvic floor muscles at different stages of resting state and contraction state of the two groups, and the subjective feelings of the patients were evaluated in combination with relevant scales. To provide a scientific basis for abdominal breathing as an adjuvant treatment for urinary retention after spinal cord injury.


Eligibility criteria: Inclusion Criteria:(1) Meet the "International Standards for the Neurological Classification of Spinal Cord Injuries" formulated by the American Spinal Cord Injury Association, and after the end of the spinal cord shock period, the ASIA classification is B, C, and D, and the clinical manifestations are urinary retention, residual urine \> 100ml, and gender is not limited; (2) Age 16-80 years old; (3) The course of the disease is within 12 months; (4) Intermittent catheterization; (5) Pelvic floor muscle function test shows pelvic floor muscle hypotonia; (6) Have good communication skills, voluntarily participate in the trial and sign the informed consent form.

-

Exclusion Criteria:

(1) Patients with severe urinary tract infection and hydronephrosis; (2) Those with other serious diseases; (3) Respiratory failure or tracheostomy; (4) patients with urinary retention not caused by spinal cord injury; (5) Dermato-electrode passers; (6) Patients with consciousness impairment and cognitive impairment; (7) Patients with poor treatment compliance and inability to follow doctor's instructions.

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Primary outcomes:
measure: Bladder residual urine output at 3 weeks
timeFrame: Three weeks
Secondary outcomes:
measure: Glazer assessment value
timeFrame: Three weeks
measure: Short-form Health Survey-Qualiveen
timeFrame: Three weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: 107 Wenhua Xi Road, Ji'nan Shandong 250012
state: jinan
Study officials:
References: