louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04084847: Berberis Vulgaris Consumption and Blood Pressure
Official title: Effect of Berberis Vulgaris Consumption on Blood Pressure and Plasma Lipids in Subjects With Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Cardiovascular Risk Factor
Lipid Profile
Keywords: Barberry
Berberis vulgaris
Blood pressure
Lipids
Inflammation
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of barberry consumption on systolic and diastolic blood pressure, serum lipids, and inflammatory status. The study will involve cases having elevated BP (129/ \< 85) and known hypertensive patients on medical treatment. Seventy people will be randomized into two groups, including intervention (barberry) or placebo groups.

Before and after of 8 week intervention, 24-hour ambulatory blood pressure monitoring will be done and fasting venous blood sample will be taken to measure plasma lipids. In addition, 24-hour urine will be collected to measure its sodium content and estimate sodium intake.


Eligibility criteria: Inclusion Criteria:

* willingness to participate in the study
* age between 20-65 years
* having elevated BP (129/ \< 85) and known hypertensive patients on medical treatment
* at least one other classical cardiovascular disease risk factors, including hyperlipidemia or diabetes mellitus

Exclusion Criteria:

* Unwillingness to continue participation
* BMI\> 30
* patients on nitrates
* high doses of statins consumption (Atorvastatin\>40 mg/day or Rosuvastatin\>20 mg/day)
* consumption of vitamins or minerals supplements during past month
* Chronic kidney disease stage 4 or 5

Primary outcomes:
measure: blood pressure
timeFrame: at 8 weeks
Secondary outcomes:
measure: lipid profile
timeFrame: at 8 weeks
measure: plasma NOx
timeFrame: at 8 weeks
measure: Inflammatory cytokine
timeFrame: at 8 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rajaei Cardiovascular, Medical & Research Center
Study officials:
References:
citation: Emamat H, Zahedmehr A, Asadian S, Nasrollahzadeh J. The effect of barberry (Berberis integerrima) on lipid profile and systemic inflammation in subjects with cardiovascular risk factors: a randomized controlled trial. BMC Complement Med Ther. 2022 Mar 7;22(1):59. doi: 10.1186/s12906-022-03539-8.
citation: Emamat H, Zahedmehr A, Asadian S, Tangestani H, Nasrollahzadeh J. Effect of barberry (Berberis vulgaris) consumption on blood pressure, plasma lipids, and inflammation in patients with hypertension and other cardiovascular risk factors: study protocol for a randomized clinical trial. Trials. 2020 Nov 27;21(1):986. doi: 10.1186/s13063-020-04918-7.
Clinical trial NCT06445647: Effect of Core Exercise on ADL in Hemodialysis
Official title: Effect of Core Stability Exercise Training on Activities of Daily Living, Fatigue Level and Balance in Hemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialysis
Keywords: Core Exercise
ADL
Balance
Hemodialysis
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Finding the effect of core stability exercises with breathing exercises on Activities of daily living (ADLs), fatigue level and balance in maintenance hemodialysis patients.

Detailed description: Sixty patients will be randomly assigned into two equal groups, the experimental (EX) group and the control group (CON). The participants' age will be 50-65 years and undergo hemodialysis. The Ex-group will attend three sessions/week of core stability exercise training (CSE) combined with Deep Breathing (25:30-min) for 8 weeks, the CON will attend 3 sessions/week of Deep Breathing (15-min) for 8 weeks. All the patients received only routine hemodialysis department care.

Eligibility criteria: Inclusion Criteria:

* Adults ranging from 55- 70 years old of both genders.
* Diagnosed as maintenance hemodialysis for at least 6 months or more.
* Free from mental illness, neuromuscular disorders, and serious lung problems and able to implement the interventional exercise.

Exclusion Criteria:

* Obesity (BMI ≥ 30 kg/m2)
* Orthopeadics or neurological problems that interferes with training.
* History of pulmonary problems (COPD, pneumonia)
* History of Myocardial infarction and/or cardiothoracic surgery
* Unstable medical status
* Dementia that interferes with the ability to follow instructions.
* History Chronic Fatigue Syndrome (CFS).

Primary outcomes:
measure: Activities of Daily Livings (ADLs)
timeFrame: up to 8 weeks
measure: Fatigue
timeFrame: up to 8 weeks
measure: Balance
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kz hospital
Study officials:
affiliation: National institute for Gerontology
name: Mohammed S Saif
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01014247: Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation
Official title: A Randomized, Double-blind, 2-way Crossover, Placebo-controlled Study to Investigate the Influence of a Single-dose of Moxifloxacin on the QTc Interval in Healthy Male and Female Subjects for Positive Control Validation in Selected Centers of the PATENT-1 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: QTc Evaluation
Electrocardiography
Keywords: Moxifloxacin
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-11-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of moxifloxacin on the QT interval in order to gain information on the validity of results that will be collected during another clinical study testing riociguat in patients with pulmonary arterial hypertension (PATENT-1 study).


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age 18-75 years - Normal ECG Exclusion Criteria:
* Abnormal ECG - Intolerance to fluorochinolones

Primary outcomes:
measure: QTc interval at 3 hours
timeFrame: Day 1 of treatment period 1 and 2
Secondary outcomes:
measure: Safety variables
timeFrame: Up to last visit of follow up
measure: Pharmacokinetic parameters
timeFrame: On different time points
Other outcomes:
Locations:
city: Melbourne
country: Australia
state: Victoria
city: Gießen
country: Germany
state: Hessen
city: Dresden
country: Germany
state: Sachsen
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: London
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01919047: Drug Use-Results Survey of Betanis Tablets in Japan
Official title: Drug Use-Results Survey of Betanis Tablets 25 and 50 mg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: overactive bladder
mirabegron
occurrence of adverse events
Overactive Bladder Symptom Score
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-08-08
Enrollment: 10711
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 who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.

Brief summary: This study is to determine the following information.

1. The occurrence of adverse drug reactions in clinical settings.
2. Factors potentially impacting safety, effectiveness, and other aspects.

Detailed description: This survey aims to determine the following information and the need for conducting specified drug use-results surveys and post-marketing clinical studies in patients using Betanis (generic name: mirabegron):

1. The occurrence of adverse drug reactions in clinical settings.
2. Factors potentially impacting safety, effectiveness, and other aspects.

Items of Particular Interest:

* Safety and effectiveness in patients with hepatic impairment and patients with renal impairment.
* Safety and effectiveness when mirabegron is used concomitantly with other drugs (α1 blockers, anticholinergic agents, 5α reductase inhibitors, drugs with a potent CYP3A4-inhibiting effect, drugs with a CYP3A4-inducing effect, drugs metabolized primarily by CYP2D6, and other frequently used drugs).
* The occurrence of cardiovascular adverse events.
* The occurrence of adverse events related to increased intraocular pressure.
* The occurrence of urinary retention

Eligibility criteria: Inclusion Criteria:

* Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.

Primary outcomes:
measure: Occurrence of adverse events and adverse drug reactions
timeFrame: For 12 weeks
Secondary outcomes:
measure: Changes in OABSS (overactive bladder symptom score)
timeFrame: baseline and at 12 weeks (or last observation period)
measure: Items of particular interest
timeFrame: baseline and at 12 weeks (or last observation period)
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT06904547: Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC
Official title: Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC: A Multi-center, Observational, Prospective Real-world Cohort Study (LORES)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ALK-Positive NSCLC
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 100
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: adult patients with ALK-positive locally advanced or metastatic NSCLC

Brief summary: This is a prospective, multicenter, non-interventional, single-arm, real-world study planned to be conducted in China, aimed at exploring the resistance mechanisms of first-line lorlatinib treatment in patients with ALK-positive locally advanced or metastatic NSCLC, as well as the efficacy and safety of sequential treatments following lorlatinib resistance in the real-world setting.


Eligibility criteria: Inclusion Criteria

1. Age: Patients aged 18 years or older;
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC
3. Documened ALK resrrangemen by approved test (eg.. FisH,IHC. .r NGS).
4. first-line loelaninab treatment fom Apr2023-Apr-2027.
5. Evidenoe of popression to first-line lorlztinib within 2 weekes.

Exclusion Criteria

1. Previous treatment with other ALK-TKIs: Patients who have previously received any ALK TKI other than lorlatinib;
2. Concomitant medications: Patients who have received any systemic anti-tumor treatment other than lorlatinib before enrollment.

Primary outcomes:
measure: mechanisms of resistance to first-line lorlatinib
timeFrame: 24 months
Secondary outcomes:
measure: Exploring the sequential treatment strategies and their efficacy and safety after first-line progression with lorlatinib
timeFrame: 24 months
Other outcomes:
measure: To determine the optimal sequential treatment strategies for different resistance mechanisms and the impact of these resistance mechanisms on patient outcomes in sequential treatment
timeFrame: 24 months
Locations:
Study officials:
References:
Clinical trial NCT02858947: Three-Year Clinical Evaluation of Class II Posterior Composite Restorations
Official title: Three-Year Clinical Evaluation of Class II Posterior Composite Restorations Placed With Different Techniques and Flowable Composite Linings in Endodontically Treated Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: composite resin
bulk-fill
teeth endodontically-treated
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the clinical effectiveness of direct resin composite restorations placed with different placement techniques (incremental or bulk) and with different flowable linings (conventional or bulk-fill flowable) used in open-sandwich technique, in endodontically treated Class II cavities (mesio-occlusal or disto-occlusal), in a randomized controlled comparison.

Detailed description: Forty-seven pairs Class II (mesio-occlusal or disto-occlusal) composite restorations were placed in 37 patients. In all cavities, Adper Single Bond 2 was used. In one of the cavities of each pair, a conventional flowable composite, Aelite Flo, was applied in approximately 2mm thick, and the remaining cavity was restored incrementally with GrandioSO. In the second cavity, a bulk-fill flowable composite, x-tra base, was applied in approximately 4 mm thick in bulk increments and the remaining 2mm occlusal part of the cavity was restored with GrandioSO. All cavities were restored with open-sandwich technique by the same operator. At baseline and after 6-month, 1-, 2- and 3-year follow-up visits, restorations were evaluated by Modified USPHS criteria.

Eligibility criteria: Inclusion Criteria:

* Permanent premolars and molars without any restorations were included in the study. Every tooth included in the study had neighboring teeth and were in occlusion to antagonistic teeth.

Exclusion Criteria:

* Patients were excluded who needed indirect restorations due to significant loss of tooth structure, known allergies to product ingredients, had poor oral hygiene and a history of bruxism.

Primary outcomes:
measure: Clinical performance evaluation of different composite resin restorations with USPHS criteria
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06157047: Evaluation of the Crestal Bone Expansion Obtained With the Magnetic Mallet® During the Preparation of the Implant Site
Official title: Evaluation of the Crestal Bone Expansion Obtained With the Magnetic Mallet® During the Preparation of the Implant Site
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Alveolar Ridge
Lead sponsor: Universita degli Studi di Genova
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to evaluate the use of a magnetodynamic instrument (Magnetic Mallet®, Metaergonomica, Turbigo, Italy) to perform a horizontal bone expansion in edentulous sites that need to be rehabilitated with a dental implant.

Detailed description: From October 2019 to May 2022, a sample of 15 patients, 11 men and 4 women, age between 39 and 78 years, was analyzed. A total of 18 conical-shaped implants with a diameter of 3.80 mm and a length between 10 and 11.5 mm were inserted in the maxillary region in the area between the lateral incisor and the first upper molar. The patients were treated by two different surgeons.

Eligibility criteria: Inclusion Criteria:

* Patients with maxillary mono-edentulism between the lateral incisor and the first upper molar with a bone crest measuring between 4-6 mm;
* Insertion of conical implants with dimensions 3.80 x \> 10 mm;
* Correct occlusal relationships between upper and lower jaw;
* Patients willing to cooperate and follow the instructions given by the clinicians.

Exclusion Criteria:

* Smokers \> 15 cigarettes per day;
* Patients with systemic diseases;
* Irradiation to the head/neck region within 12 months prior to surgery;
* Pregnancy or breastfeeding;
* Poor oral hygiene and lack of motivation to return for checkups;
* Edentulous area for less than 1 year;
* Edentulousness of the lower jaw.

Primary outcomes:
measure: bone thickness at T0
timeFrame: Before the surgery
measure: bone thickness at T1
timeFrame: Immediately after the implant site preparation
measure: bone thickness at T2
timeFrame: Immediately after the implant insertion
Secondary outcomes:
measure: bone thickness at T3
timeFrame: 3 months
Other outcomes:
Locations:
city: Genova
country: Italy
facility: PAD 4 ospedale san martino
Study officials:
References:
Clinical trial NCT05808647: Low Energy Availability and Pituitary Function (LEAP Study)
Official title: A Randomized Cross-over Study of Low Energy Availability on Pituitary Function in Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypogonadotropic Hypogonadism
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to learn more about reproductive hormones and if they change in response to 5-days eating an individualized, standardized diet at two levels: energy balance and low energy intake.


Eligibility criteria: Inclusion Criteria:

* Female
* Age 18-30
* Body mass index between 18.5-24.9 OR 30-45
* Have regular menstrual cycles between 18-40 days over the past 6 months
* Weight stable (not gained or lost 5kg) in the past 3 months

Exclusion Criteria:

* Using hormonal birth control currently or within the past three months
* Polycystic ovary syndrome (current or past diagnosis)
* Pregnant, lactating, planning to become pregnant in next 6 months
* Engaging in regular intentional aerobic exercise
* Significant medical issues (e.g.,cardiovascular disease or diabetes)

Primary outcomes:
measure: Change from baseline in stimulated pituitary function, as measured by Luteinizing hormone (LH) area under the curve (AUC) over two hours following pituitary stimulation with a physiologic bolus intravenous dose of gonadorelin acetate
timeFrame: Baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado Anschutz School of Medicine
name: Ann E Caldwell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06558747: Comparison of the Clinical Success of Pediatric Zirconia Crowns Applied with Different Luting Cements
Official title: Comparison of the Clinical Success of Pediatric Zirconia Crowns Applied with Different Luting Cements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Dental Plaque
Dental Caries in Children
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 53
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to evaluate and compare the clinical outcomes of prefabricated zirconia crowns (PZCs) for primary molars cemented with different luting cements. The main questions to answer are:

Will there be any difference in the clinical success regarding retention among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding periodontal health among the PZCs cemented with different luting cements? Will there be any difference in the clinical success regarding pulpal survival among the PZCs cemented with different luting cements? Fifty-three children (60 teeth), between 5 and 11 years old enrolled for the study. Researchers will compare the retention status, plaque index (PI), gingival index (GI), and probing depth (PD) scores, and endodontic/periodontal pathology of PZCs.

Participants will:

- visit the clinic 1st,3rd,6th,12th months after the restoration.


Eligibility criteria: Inclusion Criteria:

Patients:

* no history of allergies
* a Frankl scale score of 3 or 4
* has at least one carious primary molar

Teeth:

* No percussion or palpation sensitivity
* No pathological root resorption
* No abscess and/or fistula
* No radiolucency at the furcation area
* No prior pulpal treatment
* Presence of permanent successor
* No mobility or periodontal disease
* Normal position of permanent successor
* An interproximal decay and/or extensive decay with at least 2 surfaces
* If present, physiological root resorption no more than one-third of the root
* Opposing teeth in occlusal contact
* Normal lamina dura and periodontal space

Exclusion Criteria:

* congenital and/or developmental defects
* history of bruxism
* skeletal and/or dental malocclusion
* history of trauma
* infraocclusion

Primary outcomes:
measure: Retention Status
timeFrame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Secondary outcomes:
measure: Pulpal Survival
timeFrame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
measure: Plaque Index
timeFrame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
measure: Gingival Index
timeFrame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
measure: Probing Depth
timeFrame: Evaluations were conducted at the 1st, 3rd, 6th, 12th months.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Department of Pediatric Dentistry, Akdeniz University
Study officials:
References: