louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06682741: Comparison of Different Training Programs on Cognitive Function
Official title: Comparison of the Effects of Different Training Programs on the Levels of Cognitive Function
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Keywords: physical activity
neurotrophins
neuroprotection
cognitive function
MCI
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 500
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of the project is to identify the most effective exercise modalities in terms of neuroprotective effects and FP improvement.

Hypothesis: Dancing will increase BDNF, GDNF and CLU levels to a greater extent than traditional forms of AF, resulting in significantly greater improvements in FP in subjects aged ≥ 60 years. The study will involve 60 women aged ≥ 60 years, randomly and equitably assigned to training groups (i.e., resistance training using body weight, dance) and a control group (i.e., a group of physically inactive women).

Methodology:

Participants: 60 women aged ≥ 60 randomly and equally assigned to training groups (Dance and Resistance training) and a control group (i.e., physically inactive women)

Scientists will compare the impact of different forms of physical activity on cognitive functions

Detailed description: The training interventions will last 6 months. The intensity of physical activity will be determined as a percentage of maximum heart rate (HRmax), assessed based on a fitness test (Chester Step Test), using data from mobile devices monitoring physical activity. Cognitive function (CF) levels, and the concentrations of GDNF, BDNF, and CLU, as well as the Chester Step Test, will be evaluated twice: once at baseline and once after the training programs. Blood samples for measuring neurotrophin and CLU levels will be collected in the morning, after an overnight fast (approximately 12 hours since the last meal). The concentrations of neurotrophins and CLU will be measured using the ELISA method. CF will be assessed using standardized and validated neuropsychological tests.

Expected Outcomes: Greater improvement in CF in the dance group compared to the resistance training and control groups, with higher levels of BDNF, GDNF, and CLU in the dance group.

Eligibility criteria: Inclusion Criteria:

* women

Exclusion Criteria:

* previous diagnoses of cardiovascular diseases

Primary outcomes:
measure: tle level of cognitive functions
timeFrame: before and after 12 months of interventions
Secondary outcomes:
measure: blood markers
timeFrame: before and after 12 months of intervention
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Physical Education
Study officials:
affiliation: Poznan University of Physical Education
name: Joanna Ratajczak, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04438941: Contribution of a Prone Team in Intensive Care During the Covid-19 Epidemic
Official title: Contribution of a Prone Team in Intensive Care During the Covid-19 Epidemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV2
Keywords: Mechanical ventilation
ICU
Covid-19
SARS-CoV-2
ARDS
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient hospitalized in intensive care at the NHC, diagnosed COVID + and requiring a VD session

Brief summary: SARS-CoV-2 induced by COVID 19, involved the hospitalization of 101,932 patients in France, including 4,007 in intensive care (source: Santé Publique France). Alsace was one of the most affected regions on the metropolitan territory with a large number of patients hospitalized at the University Hospital of Strasbourg.

In view of the seriousness of the epidemic and the rapid arrival of new patients requiring mechanical ventilation, 3 new intensive care units have been created on the NHC site alone, making it possible to accommodate a maximum of 111 patients (compared to 52 during normal periods).


Eligibility criteria: Criteria for inclusion :

* Major patient (≥18 years old)
* Patient hospitalized in intensive care at the NHC, diagnosed COVID + and requiring a VD session of which at least one is performed by the dedicated team.
* patient who has not expressed, after information, his or her opposition to the re-use of his or her data for the purposes of this research

Exclusion criteria :

* Subject who expressed opposition to participating in the study
* Subject under guardianship, curatorship or safeguarding of justice

Primary outcomes:
measure: Analysis of the effect of prone position in patients with covid-19 in intensive care
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil
Study officials:
References:
Clinical trial NCT06921941: Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Digoxin and Rosuvastatin
Official title: A Phase 1, Open-Label, Two-Part Study to Evaluate the Effect of a Single Oral Dose of Bemnifosbuvir/Ruzasvir Fixed Dose Combination on the Pharmacokinetics of Digoxin and Rosuvastatin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Drug-drug interaction study between Bemnifosbuvir/Ruzasvir and Digoxin or Rosuvastatin


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.
* Minimum body weight of 50 kg and body mass index (BMI) of 18-30 kg/m2.
* Willing to comply with the study requirements and to provide written informed consent.

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
* Abuse of alcohol or drugs.
* Use of other investigational drugs within 28 days of dosing.
* Concomitant use of prescription medications, or systemic over-the-counter medications.
* Other clinically significant medical conditions or laboratory abnormalities.

Primary outcomes:
measure: PK of Digoxin and Rosuvastatin (Cmax)
timeFrame: Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15
measure: PK of Digoxin and Rosuvastatin (AUC)
timeFrame: Digoxin: Days 1,15, 29; Rosuvastatin: Days 1, 8, 15
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Atea Study Site
state: Montreal
Study officials:
References:
Clinical trial NCT03682341: Oxidative Stress Gene Polymorphism and Ovarian Reserve Functione
Official title: Study of the Relationship Between Oxidative Stress Gene Polymorphism and Individual Variation of Ovarian Reserve Function in Patients With Ovarian Endometrioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recruitment
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ovarian endometriosis cyst and teratoma cyst

Brief summary: the relationship between FOXO3A-bim pathway gene polymorphisms and ovarian reserve function of paitients with ovarian endometrioma

Detailed description: Ovarian reserve refers to the left ovarian cortex follicle growth, development, the quantity and quality of potential ability of oocytes, reflects the fertility in women. Ovarian endometrioms have an effect on ovarian reserve function. Oxidative stress is one of the important reasons. The effect has individual differences and the mechanisms are not clear.FOXO3A-bim pathway gene polymorphisms have been reported to related to individual variation of ovarian reserve function of paitients with POF. Our working hypothesis is that FOXO3A-bim pathway gene polymorphisms are also related to ovarian reserve function of paitients with ovarian endometrioma. In recent 10 years, we have set up a database including more than 2000 cases of ovarian endometrioma. In this project, we are going to investigate the oxidative stress factors, the level of sexual hormone, ultrasound information and the relationship between FOXO3A-bim pathway gene polymorphism.All these multi-diciplinary research will lead to novel understanding of individual variation of ovarian reserve function.

Eligibility criteria: Inclusion Criteria:

20 to 35 years old, non-menstrual period, not in pregnancy or puerperal period, diagnosed with ovarian cyst according to preoperative clinical symptoms, physical examination, ultrasound, CA125 and other non-surgical diagnosis methods, and all the participants having surgical indications, and ultimately conformed through histopathological diagnosis

Exclusion Criteria:

Participants receiving hormone therapy within the past six months, HIV or hepatitis B/C positive, autoimmune diseases, endocrine diseases and systemic diseases (such as diabetes, hormone therapy diseases, severe liver and kidney dysfunction), severe mental illness and malignant tumors.

Primary outcomes:
measure: difference in ovarian reserve function
timeFrame: 4 months
Secondary outcomes:
measure: FOXO3A-bim pathway gene polymorphism
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Jinhua Leng, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02397941: Diastasis Recti Abdominis and Abdominal Muscles
Official title: Diastasis Recti Abdominis and Abdominal Muscles in Pregnant and Non-pregnant Women
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Interrectal Distance
Diastasis Recti
Dimensions of the Muscles of the Lateral Abdominal Wall
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion:

* non-pregnant women aged 20-45 y with a BMI \< 30 kg/m2 who never were pregnant
* pregnant women aged 20-45 y with a BMI \< 30 kg/m2 before pregnancy

Brief summary: Purpose of the study is the assessment of interrectal distance and dimensions of the muscles of the lateral abdominal wall in pregnant and non-pregnant women

Detailed description: * Purpose of the study is the assessment of interrectal distance and dimensions of the muscles of the lateral abdominal wall in pregnant and non-pregnant women
* Assessment via ultrasound measurement transabdominally
* 3 groups of participants: 1.) 20 pregnant women, who have never been pregnant before; 2.) 40 pregnant women with their first pregnancy, followed over the course of pregnancy; 3.) 20 women1-5 days after delivery (10 after spontaneous delivery, 10 after planned cesarean section)
* comparison between pregnant and non-pregnant women; evaluation of influence of pregnancy and mode of delivery

Eligibility criteria: Inclusion Criteria:

* non-pregnant women aged 20-45 y with a BMI \< 30 kg/m2 who never were pregnant
* pregnant women aged 20-45 y with a BMI \< 30 kg/m2 before pregnancy

Exclusion Criteria:

* abdominal pre-operations
* chronical lung diseases
* constipation
* maternal collagenosis
* polyhydramnion (AFI \> 25)
* uterus fibroids \> 10 cm
* inability to perform Valsalva

Primary outcomes:
measure: interrectal distance
timeFrame: baseline
Secondary outcomes:
measure: measurement of the abdominal muscles of the lateral abdominal wall by ultrasound.
timeFrame: baseline
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Nina Kimmich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05649241: QuitAid Pilot Feasibility Trial
Official title: Testing the Efficacy, Feasibility and Acceptability of a Pharmacist-Delivered Medication Therapy Management Approach to Smoking Cessation for Rural Smokers in Appalachia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2x2 factorial design
Primary purpose: TREATMENT

Brief summary: Adult smokers were recruited through an independent pharmacy in rural Appalachia and were randomized to 1 of 8 treatments, including medication and/or therapy from the pharmacist, to help quit smoking.

Detailed description: 24 adult smokers were recruited through an independent pharmacy in rural Appalachia were randomized to 1 of 8 treatments: (1) pharmacist delivered QuitAid intervention (Yes vs. No), (2) Combination NRT Gum + NRT Patch (vs. NRT patch), and/or (3) 8 weeks of NRT (vs. standard 4 weeks). All participants received 4 weeks of NRT patch in addition to the components to which they were assigned. Participants completed baseline and 3-month follow-up assessments. The primary outcomes were feasibility of recruitment and randomization, retention, treatment adherence and fidelity.

Eligibility criteria: Inclusion Criteria:

* smokers must have smoked at least 5 cigarettes per day for the past 6 months
* be willing to set a quit date in the next 30 days
* own a cell phone
* be over 18 years of age
* not be pregnant or planning to become pregnant in the next 6 months
* not have any medical contraindications to using NRT

Exclusion Criteria:

* Those who are pregnant or plan to be
* Those under 18 years of age
* Those with a medical contradiction
* Those who do not own a cell phone
* Those who have not smoked 5 cigarettes per day for the last 6 months
* Those who are unwilling to set a quit date within 30 days

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: 3 months
measure: Feasibility of randomization
timeFrame: 3 months
measure: Retention
timeFrame: 3 months
Secondary outcomes:
measure: Tobacco Use
timeFrame: 3 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Melissa Little, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01915641: CPAP Improves the Walking Capacity in Patients With COPD and OSA
Official title: CPAP Improves the Walking Capacity in Patients With COPD and OSA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Walking Capacity
Keywords: walking capacity
COPD
OSA
CPAP
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We have reported that CPAP treatment improved the walking capacity of overlap syndrome patients.

However, the previous study was not randomized, double blinded study. Therefore, we design a prospective, randomized, double blinded, controlled, cross-over trial to confirm this finding.

Detailed description: inclusion criteria :

* COPD : FEV1/FVC \< 70%, no response to bronchodilator (FEV1 change \<12% and \<200ml)
* OSA : AHI \> 15/h, obstructive type predominant

exclusion criteria :

* any malignancy
* pregnancy
* claustrophobia
* age\<18

primary outcome : exercise capacity (walking distance (meter), measured by incremental shuttle walking test)

Method : For those fit in criteria. CPAP titration will be performed to determine the optimal pressure Baseline measurement : incremental shuttle walking test, urine catecholamine, heart rate variability, muscle power and other baseline characteristics Randomized those patients to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement

Eligibility criteria: Inclusion Criteria:

* FEV1/FVC \< 70%, no response to bronchodilator (FEV1 change \<12% and \<200ml)
* OSA : AHI \> 15/h, obstructive type predominant

Exclusion Criteria:

* any malignancy
* pregnancy
* claustrophobia
* age\<18

Primary outcomes:
measure: exercise capacity (walking distance (meter), measured by incremental shuttle walking test)
timeFrame: CPAP treatment for 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Thoracic Medicine, Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Thoracic Medicine, Chang Gung Memorial Hospital 199 Tun-Hwa N. Rd., Taipei, Taiwan
name: TSAI-YU WANG, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Thoracic Medicine, Chang Gung Memorial Hospital
name: TSAI-YU WANG, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02332941: Treatment -Resistant Neovascular Age-Related Macular Degeneration
Official title: Intravitreal Rituximab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Macular Degeneration
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 5
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if treatment of Age Related Macular Degeneration (AMD) with a new medication,rituximab is effective. To address this issue, investigators propose a clinical trial in which patients with late stage disease, poor vision and who have failed treatment by conventional means will receive rituximab by direct injection into the affected eye and will be followed for improvement in the structure of their retina. Age Related Macular Degeneration (AMD) is a leading cause of vision loss in the elderly with routine care involving injections in the eye to improve and to prevent worsening of vision. However, some patients do not respond to the medications that we currently have and as such an alternative medication is needed. One potential medication is rituximab, which has been injected into the eye for primary eye cancer, and has been tolerated well and led to patient improvement. Investigators will obtain baseline eye tests then plan on injecting this medication in to the eye of our patients with late stage AMD, by first placing numbing drops into the eye, then injecting the medication directly into the eye using sterile techniques. Investigators will then follow the patient and repeat eye tests to monitor for improvements.


Eligibility criteria: Inclusion Criteria:

* Over the age of 40
* Patients who have a diagnosis of wet age-related macular degeneration
* Patients who have a central visual acuity ,20/200
* Patients who have been deemed "treatment-resistant" at the discreation of the treating physician

Exclusion Criteria:

* Patients with treatment failure for neovascular AMD
* Patients who have tried multiple anti-vegf medication without anatomical or objective improvement

Primary outcomes:
measure: Central Macular Thickness
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: St Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Rithwick Rajagopal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04164641: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration
Official title: Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Single Center, Non-Randomized, Single treatment group
Primary purpose: TREATMENT

Brief summary: Determining whether the utilization of Noraxon myoRESEARCH Software gait analysis Evaluation and orthotic gait Correction can reduce diabetic foot ulceration Or subsequent amputation in patients with a history of a diabetic foot ulceration.

Detailed description: The purpose of this study is to identify emerging abnormal structural pathology of the vulnerable re-ulcerative diabetic foot incorporating physical therapy evaluation as well as the Noraxon gait analysis to generate quantitative and qualitative gait data. Once peak foot pressures and gait pathology is identified, gait remedy is fabricated including either a foot orthotic and/or an ankle foot prosthesis. Evaluation of constructed remedy will then be evaluated focusing on gait analysis data to validate decreased plantar foot peak pressures and gait realignment towards the reduction of the diabetic foot re-ulceration and subsequent foot or limb loss.

Eligibility criteria: Inclusion Criteria:

* History of healed diabetic foot ulceration
* Over 18 years of age

Exclusion Criteria:

Patients who are:

* under 18 years of age
* non-diabetic
* non-ambulatory
* non-healed wounds.

Primary outcomes:
measure: Number of re-ulceration occurrences
timeFrame: One year
Secondary outcomes:
measure: Number of major proximal amputation occurrences
timeFrame: One year
measure: Change of peak plantar pressure (n/cm^2)
timeFrame: Every 3 months, up to one year
measure: Change of length of gait (m)
timeFrame: Every 3 months, up to one year
measure: Location of amputation
timeFrame: One year
measure: Number of patients who remain in remission
timeFrame: One year
measure: Percentage of patients who do not experience re-ulceration after custom orthosis
timeFrame: One year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ronald Sherman, DPM, MBA
role: PRINCIPAL_INVESTIGATOR
References: