louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00446485: Efficacy and Safety of Ginkgo Biloba Extract in Mild Cognitive Impairment and Cerebrovascular Insufficiency
Official title: Efficacy and Safety of Ginkgo Biloba Standardized Extract (24% Ginkoflavonoglicozides and 6% Terpenes) in Treatment of Mild Cognitive and Concentration Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mild Cognitive Impairment
Cerebrovascular Insufficiency
Keywords: ginkgo biloba
cerebrovascular insufficiency
mild cognitive impairment
concentration impairment
Lead sponsor: Milsing d.o.o.
Sponsor class: OTHER
First posted: 2007-03-13
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine weather Ginkgo biloba standardized extract (24% ginkoflavonoglicozides and 6% terpenes) is effective in treatment of cognitive and concentration impairment

Detailed description: Inclusion criteria is cerebrovascular insufficiency MNSE\>20. 90 patients are divided into three groups randomly. First group is being administered 120 mg ginkgo biloba extract, second group 60 mg of the extract and the third group has being administered placebo during the period of 6 months. Methods used for evaluation are SCAG, MMSE, MDRS, VFT, CGI, TCD and color Doppler of carotid arteries. Methods used for follow up safety include: routine blood tests, biochemical tests, neurologic and physical examination, vital signs and ECG.

Eligibility criteria: Inclusion Criteria:

* cerebrovascular insufficiency and mild cognitive disorder (MMSE=20-28)

Exclusion Criteria:

* pregnancy
* cognitive disorder caused by psychological, metabolic endocrine nutritional and heart disorder
* alcohol or drug abuse

Primary outcomes:
measure: Changes of MDRS
timeFrame: 6 months
measure: Changes of VFT
timeFrame: 6 months
measure: Changes of CGI
timeFrame: 6 months
measure: Changes of SCAG
timeFrame: 6 months
measure: Changes of MMSE
timeFrame: 6 months
Secondary outcomes:
measure: Changes of TCD, and color Doppler of carotid arteries
timeFrame: 6 months
measure: Changes of platelets, hematocrit, prothrombin time, and activated partial tromboplastin time
timeFrame: 6 months
measure: Changes of total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides
timeFrame: 6 months
measure: Safety will be assessed according to occurrence of adverse events during the trial
timeFrame: 6 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29
Study officials:
affiliation: University Department of Neurology, Sestre milosrdnice University Hospital, Vinogradska 29, HR-10000 Zagreb, Croatia
name: Vida Demarin, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02981485: Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China
Official title: Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer Lymphedema
Keywords: Fat Grafting, Breast Cancer Lymphedema
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Breast cancer related lymphedema (BRCL) is a common complication following breast cancer treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in the axilla and the type of the radiation therapy. BRCL can causes cosmetic deformities, impaired physical mobility, mental discomfort, reduced quality of life and erysipelas. Therapy of BRCL is divided into conservative and operative methods. However, all the above method has some shortcomings. It is urgent to investigate new approaches to treat BRCL. In this study, fat grafting is to be used for the treatment of BRCL, and the efficacy and safety of this method will be also assessed.


Eligibility criteria: Inclusion Criteria:

Breast cancer diagnosis regardless of the date of operation and identified unilateral arm lymphedema Stage Ⅱ of lymphedema according to the standard of International Society of Lymphology The patient is able to read, understand, and complete questionnaires. Completed radiotherapy and/or chemotherapy at least 2 months prior to inclusion The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.

Exclusion Criteria:

Relapse of breast cancer Untreated infection Untreated heart failure Untreated renal failure Untreated deep venous thrombosis in the arm Iodine allergy Pregnancy Psychiatric disorders

Primary outcomes:
measure: Change in arm volume
timeFrame: Baseline, 3 months, 6months and 12 months
Secondary outcomes:
measure: Change in tissue edema
timeFrame: Baseline, 3 months, 6months and 12 months
measure: The function of the lymphatic vessel
timeFrame: Baseline, 3 months, 6months and 12 months
measure: Side effects of treatment
timeFrame: Baseline, 3 months, 6months and 12 months
measure: Change in quality of life
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Shijingshan
country: China
facility: Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College
state: Beijing
Study officials:
affiliation: Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College
name: Jie Luan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02366585: The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
Official title: The Effect of Locally Delivered Ciclosporin as an Adjunct to Healing After Treatment of Periodontal Pockets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontitis
Lead sponsor: PerioC Limited
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 23
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of the trial is to investigate the effect of locally delivered ciclosporin as an adjunct to non-surgical mechanical debridement in the treatment of chronic periodontitis and to compare it to mechanical debridement alone.


Eligibility criteria: Inclusion Criteria:

* Patients in good general health
* 2 pairs of contralateral interproximal periodontal sites with probing depths of ≥7mm in single-rooted teeth not associated with furcations or root furrows.The test sites should have a distance of at least two teeth to the control sites.
* Teeth selected should have a vital pulp as determined by thermal or electric stimulation

Exclusion Criteria:

* Patients already included in other clinical trials involving therapeutic intervention (either medical or dental)
* Periodontal treatment during the last 6 months
* Antibiotic treatment 6 months prior to the start of the trial
* Antibiotic prophylaxis required for dental treatment
* Patients with acute infectious lesions in the areas of intended treatment
* Regular anti-inflammatory medication
* Known history of ciclosporin allergy
* Ongoing medication that may affect the clinical features of periodontitis
* Patients who are smokers
* Patients that are immuno-compromized or on immunosuppressive medication
* Patients who are pregnant or lactating

Primary outcomes:
measure: Probing pocket depth (PPD)
timeFrame: 3 months
measure: Bleeding on Probing (BoP)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: The Sahlgrenska Academy, University of Gothenburg
Study officials:
affiliation: Göteborg University
name: Per Ramberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03211585: EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA
Official title: EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA (FACIAL REDNESS, TELANGIECTASIAS AND PHOTODAMAGE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rosacea
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2017-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to further quantify the safety and effectiveness of the Syneron-Candela long pulse-duration, extended sub-pulse, larger spot-size prototype Perfecta V-Beam, 595nm laser system for the treatment of facial redness associated with flushing and blushing, or rosacea. The Perfecta laser system is expected to provide effective treatment of rosacea with less bruising or purpura and greater effectiveness than previous generation systems. This study should enable optimization of treatment parameters for using the Perfecta 595nm laser for treating rosacea.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a Fitzpatrick skin type of I-IV and have Rosacea as evaluated by the treating physician.
* Subjects must have visible telangiectasia on the side of the face.
* Subjects must be willing and able to comply with all follow-up requirements.
* Subjects must be willing and able to apply sunblock SPF of 30 while exposed to the sun.
* Subject willing to have photographs taken and used in presentations or publications.

Exclusion Criteria:

* Subjects must not have had a previous laser treatment, deep chemical peel in the intended treatment site(s) within 6 months prior to treatment, oral retinoids within 6 months of their inclusion into this study or have ever taken gold therapy.
* Subjects must not have a history of keloid formation.
* Subjects with Fitzpatrick Classification of V or VI (to reduce the risk of hyper-pigmentation).
* Subjects must be willing and able to comply with all follow-up requirements.
* Subjects cannot have vitiligo, a condition where pigment is lost in the skin and white patches appear).
* Subjects not willing to avoid sun exposure or not will to apply sunblock SPF of 30 while exposed to the sun.
* Subject not willing to have photographs taken and used in presentations, publications and marketing material

Primary outcomes:
measure: The percentage reduction in the facial redness and telangiectasias of rosacea
timeFrame: two months following the final treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Main Line Center for Laser Surgery
name: Eric Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05274685: Early Renal Replacement Therapy in COVID 19 Patients With AKI Does it Improve the Outcome?
Official title: Early Renal Replacement Therapy in COVID 19 Patients With AKI Improves the Prognosis of the Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multi Organ Failure
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: patients will be divided into two equal groups, each group including 50 adult patients with a confirmed diagnosis of covid, patients with acute kidney injury, the first group will be treated with early hemodialysis, second group will be conservative until there is an urgent need for dialysis


Eligibility criteria: Inclusion Criteria:

* adult patients (≥18 years old) with confirmed severe acute respiratory syndrome coronavirus 2 infections admitted to the ICU.

Exclusion Criteria:

* •Malignancy.

  * Immuno-deficiency diseases.
  * Chronic diabetic, cardiac and hypertensive patients
  * autoimmune diseases.

Primary outcomes:
measure: reduction of Sequential Organ Failure Assessment Score
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University
Study officials:
References:
Clinical trial NCT00155285: Evaluating the Infant Complex Congenital Heart Disease by Multidetector Computed Tomography
Official title: Integrated Evaluating the Infant Complex Congenital Heart Disease by Multidetector(16)Spiral Computed Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Diseases
Keywords: heart diseases
congenital
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To test the ability of multi-detector spiral CT in evalting the infant complex congenital heart disease.

Detailed description: To test the ability of multi-detector spiral CT in evalting the infant complex congenital heart disease.

Eligibility criteria: Inclusion Criteria:

complex congenital heart disease

Exclusion Criteria:

-

Primary outcomes:
measure: Diagnostic accuracy
Secondary outcomes:
measure: sensitivity, specificity
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Dept. Medical Imaging, NTUH
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shyh-Jye Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00257985: Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2
Official title: Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Familial Hemiplegic Migraine Type 1 and 2
Healthy Volunteers
Keywords: Familial hemiplegic migraine type 1 and 2
GTN
middle cerebral artery
superficial temporal artery
headache
genotype
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
Collaborators: name: EUROHEAD
First posted: 2005-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to GTN infusion.

Detailed description: Glyceryl trinitrate (GTN) induces migraine attacks indistinguishable from spontaneous attacks in approximately 80% of migraine sufferers. After systemic administration GTN is transformed to nitric oxide (NO). Treatment of spontaneous migraine attacks with an inhibitor of NO is effective in 60% of patients. These data show that NO is involved in both initiation and maintenance of migraine attack.

The consequence of migraine gene mutations on relevant migraine pathways has never been tested. The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to GTN infusion. The project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Eligibility criteria: Inclusion Criteria:

Patients: Diagnosis of familial hemiplegic migraine (IHS-classification criteria) caused by mutations in the CACNA1A gene and the ATP1A2 gene.

Controls: healthy volunteers

Exclusion Criteria:

Controls: No primary headache in their own history

Patients and controls:

* A history of cerebrovascular disease and other CNS- disease
* A history of serious somatic and mental disease
* A history suggesting ischaemic heart disease
* A history of hypo- or hypertension
* Daily intake of medication apart from oral contraceptives
* Abuse of alcohol or medicine (opioid analgesics).
* Pregnant or breastfeeding women.

On the study day:

* No intake of a simple analgesic in the previous 48 hours
* No headache in the previous 48 hours

Primary outcomes:
measure: headache and associated symptoms , blood flow velocity of the middle cerebral artery, diameter of the superficial temporal artery
Secondary outcomes:
measure: MAP, HR
Other outcomes:
Locations:
city: Glostrup, Copenhagen
country: Denmark
facility: Danish Headache Center, University of Copenhagen, Department of Neurology, Glostrup Hospital
Study officials:
affiliation: Danish Headache Center
name: Jakob Møller Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06767085: Pain Management During Diagnostic Office Hysteroscopy in Postmenopausal Women: a Randomized Study
Official title: Pain Management With Lidocaine-prilocaine Spray During Diagnostic Office Hysteroscopy in Postmenopausal Women: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Office Hysteroscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 106
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists

Detailed description: To assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists

Eligibility criteria: Inclusion Criteria:

* Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

* Nulliparous patients patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding allergy or contraindications to lidocaine-prilocaine spray

Primary outcomes:
measure: Intensity of pain
timeFrame: 5 minutes
Secondary outcomes:
measure: Intensity of pain
timeFrame: 20 minutes
measure: ease of insertion
timeFrame: 5 MINUTES
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00376285: Effects of Fenofibrate on the Safety, Toleration and Efficacy Biomarkers of CP-742,033
Official title: A Phase 1, Randomized, Investigator and Subject Blind, Sponsor Open Study to Determine the Effects of Fenofibrate on the Safety, Toleration and Efficacy Biomarkers of CP-742,033 When Co-Administered in Otherwise Healthy Obese Adult Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether fenofibrate effects the toleration, safety, or efficacy biomarkers of CP-742,033, a drug being developed for the treatment of obesity.


Eligibility criteria: Inclusion Criteria:

* BMI of 30-40 kg/m2

Exclusion Criteria:

* Women of childbearing potential

Primary outcomes:
measure: Toleration and safety
Secondary outcomes:
measure: Efficacy biomarkers, serum lipids
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02321085: The Comparison With Clinical Impacts on Functional Capacity and Symptom Improvement According to the Rhythm Control in Patients With Heart Failure and Recent Onset Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Recent Onset Atrial Fibrillation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized (rhythm control or rate control in heart failure patients with new onset atrial fibrillation) Objective of study 1. To analyze long term outcome of patients with heart failure with new onset atrial fibrillation according to the rhythm control 2. To analyze remodeling of atrium and ventricle by the new onset AF in heart failure patients 3. To analyze the change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF


Eligibility criteria: Inclusion Criteria:

1. Patients with Heart failure and Atrial fibrillation within 1year (20\~80 years old)
2. LA diameter \< 5mm
3. LVEF 20\~49%
4. patients possible to anticoagulation and anti arrhythmic drug
5. Expected survival \>1yr

Exclusion Criteria:

1. Impossible to anticoagulation or anti arrhythmic drug
2. valvular atrial fibrillation ( Mitral valve stenosis, Mitral valve plasty, valve replacement)
3. LV ejection fraction \< 20%
4. Structural cardiac disease
5. Catheter ablation history for AF, maze surgery
6. patient with severe medical disease
7. Impossible to anticoagulation or anti arrhythmic drug

Primary outcomes:
measure: improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation
timeFrame: 1 year
measure: functional capacity according to the rhythm control in patient with heart failure and new onset atrial fibrillation
timeFrame: 1 year
Secondary outcomes:
measure: remodeling of atrium by the new onset AF in heart failure patients The change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF
timeFrame: 1 years late
measure: remodeling of ventricle by the new onset AF in heart failure patients The change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF
timeFrame: 1 years late
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References: