louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01679691: The Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Post Lower Limb Salvage Surgery
Official title: The Effect of Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Following Lower Limb Salvage Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bone Tumor
Lead sponsor: Children's Cancer Hospital Egypt 57357
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Epidural anesthesia is a very useful tool in lower limb salvage surgery, which helps pain control intra and more importantly post-operative pain. It is a well-known effect of epidural injections to cause a sympathetic stimulation and consequently vasodilatation in the lower limb vessels.

Since epidural catheters can cause vasodilatation in lower limb vessels, they can subsequently lead to increased intra and post-operative bleeding from the surgical wound.

The study will involve all patients having a bone tumor in the lower limb and subjected to tumor resection and reconstruction by prosthesis.

The patient will be randomized according to the administration of epidural anesthesia into two arms, an arm in which epidural anesthesia was employed and another arm in which the patient was subjected only to general anesthesia and the amount of intra and postoperative bleeding will be compared in both arms.

Detailed description: Assessment of intra-operative bleeding will be based upon weighing and counting of the blood soaked dressing and the amount of blood transfusion used.

Assessment of post-operative bleeding will be based upon the amount of blood collected from the suction drain and amount of blood transfusion.

All patient subjected to anticoagulant post-operative or another type of surgery other than implantation of prosthesis will be excluded from the study.

Eligibility criteria: Inclusion Criteria:

* lower limb bone tumor
* reconstruction by prosthesis

Exclusion Criteria:

* upper limb and pelvic salvage surgery.
* other methods of reconstruction than prosthesis
* use of tourniquet intra-operative.
* post-operative anticoagulation.

Primary outcomes:
measure: Measure the blood loss intra- and post-operative in both the contro and study groups
timeFrame: start of surgery until removal of sucction drain
Secondary outcomes:
measure: prolongation of hospital stay
timeFrame: the number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children's Cancer Hospital Egypt-57357
Study officials:
affiliation: Children's Cancer Hospital Egypt 57357
name: ahmed elghoneimy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05125991: Evaluation of the Effectiveness of Prepectoral Breast Reconstruction
Official title: Evaluation of the Effectiveness of the Prepectoral Breast Reconstruction With Braxon Dermal Matrix: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.

Detailed description: The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.

The study plans to collect robust data to support the prepectoral implant placement and complete coverage of implant with acellular dermal matrix in the clinical practice.

Consequently, the project plans to move toward evidence-based medicine in breast reconstruction, avoiding marketing influences and surgeon experience as the sole source of evidence.

Eligibility criteria: Inclusion Criteria:

1. Informed consent
2. Not smokers
3. No vascular comorbidities (diabetic, vasculitis, coagulation disorders)
4. BMI\<30
5. CUP B-C (or mastectomy estimated weight less than 550gm)
6. Good subcutaneous layer (\>1cm on pinch test measured in upper/medial quadrant)
7. No previous breast surgery
8. No previous breast irradiation
9. Breast Ptosis 1-2 according to Renault's classification
10. DCIS tumors
11. T1 T2 pN0 breast tumor with known favourable biologic features

Exclusion Criteria:

1. Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality)
2. Positive sentinel node biopsy requiring complete axillary dissection

Primary outcomes:
measure: Satisfaction assessed by the BREAST-Q
timeFrame: 1 year
Secondary outcomes:
measure: Immediate complications rate
timeFrame: 1 month
measure: Short term complications rate
timeFrame: 6 months
measure: Long term complications rate
timeFrame: 24 months
measure: Percentage of capsular contracture
timeFrame: 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Francesca De Lorenzi, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Institute of Oncology
name: Paolo Veronesi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01228591: Pilot Dispensing Evaluation of a Plus Power Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.


Eligibility criteria: Inclusion Criteria:

* The subject must be at least 18 years of age and no more than 45 years of age.
* The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study).
* The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D.
* Any cylinder power must be ≤ 0.75D.
* The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear.
* Systemic disease or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.
* Need any near correction.

Primary outcomes:
measure: Visual Acuity One Week After Lens Wear
timeFrame: 1 week
measure: Visual Acuity at Time of Initial Fit
timeFrame: After 10-15 minutes of lens wear
Secondary outcomes:
measure: Contact Lens Comfort Using Contact Lens User Experience (CLUE)
timeFrame: 1 week
measure: Subject Reported Vision Using Contact Lens User Experience (CLUE).
timeFrame: 1 week
measure: Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)
timeFrame: Baseline
measure: Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)
timeFrame: Baseline
Other outcomes:
Locations:
city: Winter Park
country: United States
state: Florida
city: New York
country: United States
state: New York
city: Nanticoke
country: United States
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00400491: Vitamin D Supplementation to Patients With Type 2 Diabetes
Official title: Vitamin D Supplementation to Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: diabetes
insulin
glycated hemoglobin
cholecalciferol
vitamin D
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2006-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.

Detailed description: The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.

We will include 70 patients with type 2 diabetes. They will be treated with 40.000 IU cholecalciferol per week (or placebo) for 6 months. Metabolic control will be evaluated with measurements of glycated hemoglobin, home glucose measurements, and fasting blod glucose and serum insulin. Only subjects using insulin at bedtime combined with metformin during the day will be included.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least 1 year
* age 21-75 years
* long-acting insulin at bedtime
* metformin during the day
* for women of child bearing age use of reliable method of birth control

Exclusion Criteria:

* serum creatinine above 130 umol/l for men and above 110 for women
* systolic blood pressure \> 175 or diastolic \> 104 mmHg
* heart disease
* serum calcium \> 2.54 mmol/l
* history of renal stones

Primary outcomes:
measure: glycated hemoglobin
timeFrame: 6 months
Secondary outcomes:
measure: blood pressure
timeFrame: 6 months
measure: body weight
timeFrame: 6 months
measure: Hip/waist ratio
timeFrame: 6 months
measure: lipids
timeFrame: 6 months
measure: Hs-CRP
timeFrame: 6 months
measure: insulin sensitivity
timeFrame: 6 months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Clinical Research Unit, University Hospital of North Norway
Study officials:
affiliation: University of Tromsø, Tromsø
name: Rolf Jorde, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01055691: A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets
Official title: A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Volunteers, in the Fed State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: healthy volunteers
bioequivalence
dapagliflozin
metformin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet.


Eligibility criteria: Inclusion Criteria:

* Female healthy volunteers must be post-menopausal (cessation of menses \>1year), be surgically sterile (documented) or hysterectomy or on abstinence
* Have normal physical exam, vital signs Electrocardiogram (ECG) findings, and laboratory values

Exclusion Criteria:

* Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization
* History of allergy to metformin
* Previous participation in an AstraZeneca (AZ) or BristolMyers-Sqibb dapagliflozin study

Primary outcomes:
measure: bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.
timeFrame: Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP.
Secondary outcomes:
measure: To examine the safety and tolerability of the combination of dapagliflozin and metformin.
timeFrame: Throughout study (for 4 days in each period and a follow-up visit ~6 days later)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
affiliation: Parexel
name: Georg Golor, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Parexel
name: Thomas Koernicke
role: STUDY_DIRECTOR
References:
Clinical trial NCT00758394: Clinical Study to Compare Dental Plaque Control
Official title: Clinical Study to Compare Dental Plaque Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

Detailed description: Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

Eligibility criteria: Inclusion Criteria:

* Male or female volunteers at least 18 - 53 years of age
* Good general health
* Must sign informed consent form
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures
* Moderate or advanced periodontal disease or heavy dental tartar (calculus).
* 2 or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that are currently affecting salivary function
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this study.
* Use of tobacco products
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* Presence of an orthodontic appliance which interferes with plaque scoring.
* History of allergy to common dentifrice ingredients.
* History of allergy to arginine (amino acid)
* History of allergy to bicarbonate
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Primary outcomes:
measure: Dental Plaque Index
timeFrame: 4-Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Bluestone Center for Clinical Research, NYU College of Dentistry
state: New York
Study officials:
name: Patricia Corby, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01832194: Use of Botox to Treat Scrotal Pain
Official title: Use of Botox to Treat Scrotal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Scrotal Pain
Keywords: Scrotal pain
Botox
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There are no previous reports on the use of Onabotulinum Toxin A to treat men with scrotal pain that we found published. We propose a pilot study to use Botox to block the testicular nerves on a group of 15 men with chronic scrotal pain who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using marcaine. Before and 1 month, 3 months and 6 months after the Onabotulinum Toxin A injection, the men would be asked to fill in visual analog scales for pain, a quality of life assessment, a depression index (MDI) and Chronic Epididymitis Symptom Index (CESI). They will also be subject to sensory testing of the scrotum before, after 1 month, 3 moths and 6 months.


Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Have nociceptive scrotal pain,
* Have no identifiable, reversible causes for the scrotal pain
* Have failed standard medical therapy
* Have responded temporarily to cord blocks

Exclusion Criteria:

* Are interested in trying to conceive with their partners in the next 6 months,
* Have any local infection near the site of the injections,
* Have had an allergic reaction to Botox in the past,
* Are unable to provide informed consent
* Have a history of motor neuron disease or neurogenic bladder
* Who have hemostatic disorder or who are taking aspirin, Coumadin (warfarin), Xarelto (rivaroxaban) or other blood thinners

Primary outcomes:
measure: Change in pain
timeFrame: 6 months after entering in trial
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Canada
name: Keith Jarvi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01388894: Functional MRI and MRA in Migraine With Aura
Official title: Functional MRI and MRA in Migraine With Aura
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine With Aura
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2011-07-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with migraine with aura

Brief summary: Patients who report that exposure to bright light or strenuous physical activity will induce migraine aura will be provoked using one or both of these methods. Followingly the patients will be examined by functional MRI. Íf the patients develop migraine headache, MR angiography will be performed as well. The primary study hypothesis is that the functional MRI signal will show features similar to those of the electrophysiological phenomenon of cortical spreading depression.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with migraine with aura as defined by The International Classification of Headache Disorders 2
* Age between 18 and 80 years both inclusive
* Reports that bright light or strenuous physical activity may trigger migraine aura

Exclusion Criteria:

* Contraindications towards exposure to photostimulation or strenuous exercise
* Body weight above 130 kg
* Pregnant or lactating females
* Contraindications towards MRI scanning
* History or clinical signs of: cardiovascular disease, psychiatric disease, substance abuse or any symptom or disease considered relevant by the examining physician.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
References:
Clinical trial NCT00333294: Phase II Iressa + Irradiation Followed by Chemo in NSCLC
Official title: A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* 18 to 75 years inclusive.
* At least one measurable lesions histologically confirmed inoperable stage III NSCLC.
* WHO performance status of 0 to 2 inclusive.
* Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %.
* Life expectancy of at least 6 months.
* Using secure contraceptives precautions.

Exclusion Criteria:

* Any previous anti cancer therapy for NSCLC.
* Known severe hypersensitivity to these products
* Any evidence of clinically active interstitial lung disease
* Other co-existing malignancies, symptomatic metastases.
* Abnormal blood test
* Weight loss of over 15% in the 3 months before the start of the study.
* Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.

Primary outcomes:
measure: To estimate the objective response rate in patients treated with this drug
Secondary outcomes:
measure: Determine the safety and toxicity of this drug in these patients
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Paris
country: France
facility: Research SIte
Study officials:
affiliation: AstraZeneca
name: AstraZeneca France Medical Director, MD
role: STUDY_DIRECTOR
References: