louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01885494: AFF008E: Observational Phase 1b Follow-up Extension Study for Patients With Parkinson's Disease After Immunization With AFFITOPE® PD01A
Official title: AFF008E:Observational Follow-up Extension Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE® PD01A Applied During AFF008 in Patients With Parkinson's Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: Affiris AG
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 41
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only participants of AFF008 will be offered participation in AFF008E.

Brief summary: AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been applied during AFF008 with regard to safety as well as immunological-, radiological and clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied. Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at the occasion of 4 quarterly visits. This is offered to patients who received PD01A vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will ensure standardized and controlled management of individuals who have received PD01A as part of AFF008, the Phase I study analyzing for the first time in humans this first in class candidate.


Eligibility criteria: Inclusion Criteria:

* Written informed consent signed and dated by the patient
* Participation in AFF008

Exclusion Criteria:

* History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
* Participation in the active treatment phase of another clinical trial except AFF008 within 13 weeks before Visit 1 and for the whole study duration

Primary outcomes:
measure: Tolerability and Safety
timeFrame: 52 weeks
Secondary outcomes:
measure: Immunological and Clinical Efficacy
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt, Skodagasse 32
Study officials:
affiliation: Studienzentrum der PROSENEX AmbulatoriumbetriebsgesmbH an der Confraternität-Privatklinik Josefstadt
name: Dieter Volc, Prim. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McFarthing K, Simuni T. Clinical Trial Highlights: Targetting Alpha-Synuclein. J Parkinsons Dis. 2019;9(1):5-16. doi: 10.3233/JPD-189004. No abstract available.
Clinical trial NCT02125994: Effect of 0.5% vs 0.375% Ropivacaine on Autonomous Nervous System
Official title: Comparison of the Effect of Ropivacaine 0.5% vs 0.375% on the Autonomous Nervous System During Shoulder Surgery in Beach Chair Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Surgery
Interscalene Nerve Block
Ropivacaine
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is established that the local anesthetic that is administered during an interscalene block affects the autonomic outflow to the heart. This is very well seen during shoulder surgery when the patient is positioned in beach chair pasition.

The investigators want to study the different effect of the two concentrations (0.5% and 0.375%) of ropivacaine on the autonomic nervous system through blood pressure and heart rate measurements.


Eligibility criteria: Inclusion Criteria:

* Elective shoulder surgery
* Age 18- 80 years old
* ASA I - IV
* Beach chair position

Exclusion Criteria:

* Coagulopathy disorders
* Infection at the puncture site for the interscalene block
* Neurological deficit on the side to be operated
* Allergy to local anesthetics
* Psychiatric disorders
* Patient's refusal
* Problems with patient communication
* Failure of the interscalene block

Primary outcomes:
measure: Blood pressure fluctuations
timeFrame: Completion of the surgery
Secondary outcomes:
measure: Heart rate fluctuations
timeFrame: Completion of surgery
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Private Clinic of Larissa "Asklipeiio"
Study officials:
affiliation: Private Clinic of Larissa "Asklipeiio"
name: Marina Simaioforidou, Medicine
role: STUDY_DIRECTOR
affiliation: University Hospital of Larisa
name: Metaxia Bareka, Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Clinic of Larissa "Asklipeiio"
name: George Basdekis, Medicine
role: STUDY_CHAIR
affiliation: Larissa University Hospital
name: Konstantinos Bargiotas, Medicine
role: STUDY_CHAIR
affiliation: Larissa University Hospital
name: Sokrates Varitimidis, Medicine
role: STUDY_CHAIR
affiliation: Private Clinic of Larissa "Asklipeiio"
name: Aristeidis Zibis, Medicine
role: STUDY_CHAIR
affiliation: Larissa University Hospital
name: Konstantinos Alexiou, Medicine
role: STUDY_CHAIR
References:
Clinical trial NCT02384694: Effects of a Zumba Dance Program for Postmenopausal Women With Metabolic Syndrome
Official title: ZumBeat: Effekte Eines Rhythmusorientierten Aeroben Tanz-Bewegungsprogrammes für Postmenopausale Frauen Mit Metabolischem Syndrom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: cardiorespiratory fitness
weight
quality of life
depression
menopausal symptoms
exercise barriers
executive functions
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 17
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effects of a 12-week Zumba dance intervention on fitness, anthropometric and psychometric parameters and eating behavior.


Eligibility criteria: Inclusion Criteria:

* postmenopausal women (Age 45-65)
* waist of \>94 cm or BMI \> 30kg/m2
* not physically active \>1x/week for 20 minutes
* written consent before the start of the study

Exclusion Criteria:

* involvement in other clinical studies
* unable to participate at the dance lessons
* medical contraindications for the intervention or increased risk for exercise participation

Primary outcomes:
measure: VO2peak (=peak oxygen consumption)
timeFrame: VO2peak will be assessed at T1 and T12 (baseline and after 12 weeks of intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department for Sports, Exercise and Health, Sports and Exercise Medicine, University of Basel
Study officials:
affiliation: Sports and Exercise Medicine, Department of Sports, Exercise and Health, University of Basel
name: Arno Schmidt-Trucksäss, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06506994: A Study of HRS-9057 in Patients With Heart Failure and Volume Overload
Official title: An Open Label, Tolvaptan-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Ascending Dose of HRS-9057 in Heart Failure With Volume Overload
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Heart Failure With Volume Overload
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HRS-9057 injection was compared with Tolvaptan tablets
Primary purpose: TREATMENT

Brief summary: The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload. A total of 24 subjects who experience volume overload due to heart failure despite diuretic treatment will be enrolled in the study and receive HRS-9057 injection or Tolvaptan tablets.


Eligibility criteria: Inclusion Criteria:

1. Male or female, age 18-70 years at the time of signing informed consent.
2. Diagnosed as chronic heart failure at least 1 month prior to screening.
3. Patients with CHF in whom lower limb edema, pulmonary congestion, jugular venous distension or hepatomegaly due to volume overload is present despite diuretics treatment.

Exclusion Criteria:

1. Medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening;
2. Hypovolemic hyponatremia.

Primary outcomes:
measure: The incidence and severity of any adverse events (AEs)
timeFrame: baseline up to Day 14
Secondary outcomes:
measure: Tmax for HRS-9057
timeFrame: Predose on Day 1 through Day 6
measure: Cmax for HRS-9057
timeFrame: Predose on Day 1 through Day 6
measure: Daily urine volume
timeFrame: Predose on Day 1 through Day 7
measure: Daily fluid balance
timeFrame: Predose on Day 1 through Day 7
measure: Serum sodium concentration
timeFrame: Predose on Day 1 through Day 6
measure: Serum osmolality
timeFrame: Predose on Day 1 through Day 6
measure: Urine osmolality
timeFrame: Predose on Day 1 through Day 7
measure: Body weight
timeFrame: baseline to Day 8
measure: Lower limb edema change from baseline
timeFrame: baseline to Day 8
measure: Jugular venous distension change from baseline
timeFrame: baseline to Day 8
measure: Pulmonary congestion change from baseline
timeFrame: baseline to Day 8
measure: New York Heart Association (NYHA) classification change from baseline
timeFrame: baseline to Day 8
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT03173794: CommunityRx for Hunger: A Hospital-Based Intervention
Official title: CommunityRx for Hunger: A Children's Hospital-Based Intervention to Support Caregivers in an African American Community
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Food Insecurity
Caregivers
Clinical Trial
Hunger
Health-Related Quality of Life
Patient Satisfaction
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this research program is to reduce health disparities by deploying an information-based intervention to increase caregiver utilization of community-based food supports and satisfaction with care among food insecure caregivers of hospitalized children. We will conduct a randomized controlled trial to evaluate, versus usual care, the effects of the CommunityRx-H intervention on caregiver use of food resources (primary), caregiver patient satisfaction with care (primary), caregiver mental health-related quality of life (secondary), and caregiver household food security (secondary). The proposed research will yield an understanding of how to leverage a child's hospitalization to effectively intervene on the problem of food insecurity. Findings will inform the rapidly growing field of healthcare-based interventions to address health-related social needs.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* English-speaking
* Living in 1 of the 16 ZIP code target regions
* Self-identify as a primary caregiver of a child \<18 years old hospitalized in CCH's general, intensive care or transplant units

Exclusion Criteria:

* Recollection of previous receipt of a HealtheRx

Primary outcomes:
measure: Change from baseline in use of food resources
timeFrame: Baseline, 7 days, 30 days, 60 days, and 90 days
measure: Patient satisfaction with care
timeFrame: 7 days
Secondary outcomes:
measure: Change from baseline in mental health-related quality of life
timeFrame: Baseline, 7 days, 30 days, 60 days, and 90 days
measure: Change from baseline in household food insecurity
timeFrame: Baseline, 30 days, 60 days, and 90 days
Other outcomes:
measure: Change from baseline in caregiver stress
timeFrame: Baseline, 7 days, 30 days, 60 days, and 90 days
measure: Change from baseline in caregiver burden
timeFrame: Baseline, 7 days, 30 days, 60 days, and 90 days
measure: Change from baseline in caregiving self-efficacy
timeFrame: Baseline, 7 days, 30 days, 60 days, and 90 days
measure: Change from baseline in contact Community Resource Navigator
timeFrame: Baseline, 7 days, 30 days, 60 days, and 90 days
measure: Satisfaction with navigation
timeFrame: 7 days
measure: Change in stigma during child's hospital stay
timeFrame: 7 days, 30 days, 60 days, 90 days
Locations:
Study officials:
affiliation: University of Chicago
name: Stacy Lindau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04109794: Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study
Official title: Comparison of Two Techniques in Gingival Recession Treatment. One-year Clinical Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 42 patients were treated either with E-CTG (N=20) or SCAF (N=22). The recordings included clinician-based (recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, tissue thickness, clinical attachment gain (CAG), root coverage (RC), keratinized tissue change (KTC)) and patient-based (wound healing index (WHI), dentine hypersensitivity (DH), tissue appearance, patient expectations and aesthetics) parameters that were taken at baseline, T1 (sixth week), T2 (sixth month) and T3 (first year).


Eligibility criteria: Inclusion Criteria:

* single Miller I GR defects ≤3mm at upper anterior or premolar teeth
* systemically healthy
* identifiable cemento-enamel junction (CEJ)
* PD ≤3 mm

Exclusion Criteria:

* periodontal surgery experience in the past two years
* excessive contacts
* mobility
* caries
* loss of vitality
* smoking
* pregnancy

Primary outcomes:
measure: recession depth
timeFrame: baseline
measure: recession depth
timeFrame: 6 weeks
measure: recession depth
timeFrame: 6 months
measure: recession depth
timeFrame: 12 months
Secondary outcomes:
measure: recession width
timeFrame: baseline
measure: recession width
timeFrame: 6 weeks
measure: recession width
timeFrame: 6 months
measure: recession width
timeFrame: 12 months
measure: probing depth
timeFrame: baseline
measure: probing depth
timeFrame: 6 weeks
measure: probing depth
timeFrame: 6 months
measure: probing depth
timeFrame: 12 months
measure: clinical attachment level
timeFrame: baseline
measure: clinical attachment level
timeFrame: 6 weeks
measure: clinical attachment level
timeFrame: 6 months
measure: clinical attachment level
timeFrame: 12 months
measure: keratinized tissue width
timeFrame: baseline
measure: keratinized tissue width
timeFrame: 6 weeks
measure: keratinized tissue width
timeFrame: 6 months
measure: keratinized tissue width
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Evginer MS, Olgun E, Parlak HM, Dolgun AB, Keceli HG. Comparison of two techniques in gingival recession treatment: A randomized one-year clinical follow-up study. Dent Med Probl. 2022 Jan-Mar;59(1):121-130. doi: 10.17219/dmp/137621.
Clinical trial NCT01681394: Effect of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression
Official title: Effect of the Administration of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Function
Gene Expression
Lead sponsor: Technological Centre of Nutrition and Health, Spain
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce blood pressure. However, the mechanisms implicated in these effects have not been elucidated yet. The purpose of this study is to evaluate changes in gene expression induced by the administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells (PBMC) in humans.

Detailed description: This is a prospective, randomized, controlled, double-blind and cross-over study. The intervention will consist in the administration of 250g of chocolate cream with or without the extract after 12 hours fasting. Blood samples will be taken at point 0, 2, 3 and 6 hours after the administration. At each time point, blood pressure and endothelial function (with a non-invasive method) will be measured.

Eligibility criteria: Inclusion Criteria:

1.Healthy males between the ages of 20 and 39 who do not meet any of the exclusion criteria.

Exclusion Criteria:

1. Body mass index (BMI) lower than 18 or greater than 27 Kg/m2
2. Smokers
3. Regular medication
4. Consumption of medication during the last week
5. Following a weight-loss diet
6. Vegetarians
7. Abnormal glucose levels
8. Diabetes
9. Cardiovascular disease
10. Gastrointestinal disease
11. Anemia
12. Allergy

Primary outcomes:
measure: Gene expression changes in PBMCs (using a microarray)
timeFrame: 0-6 hours
Secondary outcomes:
measure: Blood pressure
timeFrame: 0-2-3-6 hours
measure: Endothelial function (assessed by ischemic reactive hyperemia)
timeFrame: 0-2-3-6 hours
measure: Plasma levels of procyanidins metabolites
timeFrame: 0-6 hours
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Technological Center of Nutrition and Health (CTNS)
state: Tarragona
Study officials:
affiliation: University Rovira i Virgili
name: Rosa Solà, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04072094: Minimally Invasive Locking Plate Fixation vs Reamed Intramedullary Nail Fixation on Patients With Open Tibia Fracture
Official title: A Prospective Randomized Trial Comparing the Effect of Minimally Invasive Locking Plate Fixation and Reamed Intramedullary Nail Fixation on Patients With Gustilo I-III A Open Tibia Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open tíbia Fracture
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Taizhou Hospital
name: Ningbo No.2 Hospital
name: The First People's Hospital of Huzhou
First posted: 2019-08-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The best treatment for the open tibia fractures remains controversial. It is unknown whether minimally invasive locking plate or reamed intramedullary nail fixation will result in lower complication rates and better function.

Detailed description: The best fixation method for open tibial fractures remains controversial. The current standard treatment options recommended the use of intramedullary nail for treating such fractures. Recent studies also showed favorable results for the use of plates in managing open tibial fractures. However, it is unknown whether locking plate or intramedullary nail fixation will result in lower complication rates and better function.

This study is a prospective, randomized trial to compare the safety and efficiency of minimally invasive plate osteosynthesis and reamed intramedullary nails in treating type I-II open tibial shaft fractures. The investigators hypothesize that neither intervention resulted in a superior disability rating at 12 months. Outcomes evaluated will include the rate of infection, the number of re-hospitalization for the complication, the time to bone healing, Patient-Reported outcome and quality of life and other complications.

Eligibility criteria: Inclusion Criteria:

* Ages 18 - 60 years inclusive
* Open diaphyseal fracture
* Gustilo-Anderson Type I, II, IIIA

Exclusion Criteria:

* Closed, periarticular or pathological fracture
* Gustilo-Anderson Type IIIB,IIIC
* Patients with concomitant fractures in the ipsilateral limb
* The patient is unable to medically tolerate general anesthesia
* The patient is unable to provide informed consent or comply with completing questionnaires
* Tibia already infected as diagnosed by a surgeon
* The patient has been diagnosed with a severe psychiatric condition

Primary outcomes:
measure: LEFS
timeFrame: 12 months
Secondary outcomes:
measure: EQ-5D
timeFrame: 12 months
Other outcomes:
measure: SF-12
timeFrame: 12 months
measure: Fracture Healing
timeFrame: 12 months
measure: Complications
timeFrame: 12 months
Locations:
Study officials:
References:
Clinical trial NCT04620694: Impact of Arterial Cannulation Site on Vasopressor Requirement in Cardiac Surgery
Official title: Impact of Arterial Cannulation Site on Vasopressor Requirement During Cardiac Surgery: a Monocentric Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Disease
Keywords: Cardiac surgery
Aortic to radial arterial pressure gradient
Vasopressor
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients scheduled for cadiac surgery wih cardiopulmonary bypass

Brief summary: Choice of arterial cannulation site during cardiac surgery is controversial. Some physicians in our institution prefer radial artery site, others prefer aortic site (via femoral artery or brachial artery). The investigators aim to compare these two strategies for vasopressor requirement. The study hypothesis is that radial artery cannulation is associated with a larger dose of vasopressor due aortic to radial arterial pressure gradient phenomenon.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Scheduled for cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* More than one arterial cannula at the beginning of the surgery

Primary outcomes:
measure: Intraoperative vasopressor requirement
timeFrame: end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Louis Pradel
Study officials:
References: