louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01441817: Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures
Official title: Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Malleolus Fracture Bimalleolar
Fracture of Medial Malleolus
Fracture of Ankle
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine if internal fixation of the medial malleolus is necessary following open reduction and internal fixation of the lateral and, if required, the posterior malleolus treating displaced bi-or trimalleolar ankle fractures.


Eligibility criteria: Inclusion Criteria:

* Patients with Orthopaedic Trauma Association (OTA) type 44 fractures (B2-3 and C2-3).

Exclusion Criteria:

* Patients with OTA type 43 distal tibia fractures.
* Patients with soft tissue injuries involving the medial malleolus.

Primary outcomes:
measure: American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS)
timeFrame: Average of 42 months
measure: The Olerud Molander Ankle score (OMAS)
timeFrame: Average of 42 months
Secondary outcomes:
measure: Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV)
timeFrame: Average of 42 months
measure: VAS score
timeFrame: Average of 42 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT00231517: Randomised Double Blind Placebo Controlled Cross Over Design of the Efficacy of Topical Morphine for Inflammatory Pain in Children With Epidermolysis Bullosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epidermylosis Bullosa
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2005-10-04
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Randomised Double blind placebo controlled cross over design study of the efficacy of morphine for inflammatory pain in children with Epidermolysis Bullosa


Eligibility criteria: Inclusion Criteria:

* children under 18 years epidermolysis wounds requiring dressing changes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital and the Institute of Child health
Study officials:
affiliation: Institute of Child Health
name: Richard Howard, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00348517: Safety/Efficacy of Systane Free vs Refresh Liquigel
Official title: An Evaluation of the Safety and Efficacy of Systane Free FID 105783
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.


Eligibility criteria: Inclusion Criteria:

* \>/= 3 corneal staining score using NEI scoring system.
* Need artificial tears at least some of the time.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History or evidence of ocular or intraocular surgery in either eye within the past six months.
* History of intolerance or hypersensitivity to any component of the study medication.
* Use of Restasis within 30 days of Visit 1.
* Participation in an investigational drug or device study within 30 days of entering this study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change in corneal staining at Day 28 from baseline (Day 0)
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01229917: Rhinovirus Study With Lactobacillus Rhamnosus GG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Tract Infections [C08.730]
Lead sponsor: Valio Ltd
Sponsor class: INDUSTRY
Collaborators: name: University of Helsinki
name: University of Virginia
name: Medcare Ltd
First posted: 2010-10-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection.


Eligibility criteria: Inclusion Criteria:

1. Male or female in general good health (stabilized chronic illnesses and regular medications are accepted, if not otherwise mentioned in the exclusion criteria)
2. Age 18-65 years
3. Serum neutralizing antibody titer of 1:4 or less for the challenge rhinovirus
4. No clinically significant finding on the pre-study nasal examination
5. Females must have a negative urine pregnancy test, and women of child-bearing potential must be using an effective method of birth control such as, but not limited to birth control pills, contraceptive foam, diaphragm, IUD, surgical sterilization, abstinence, or condoms
6. Written informed consent must be obtained at enrollment into the study

Exclusion Criteria:

1. Suffer from or have a history of significant allergic rhinitis at the time of study
2. Bronchial asthma or other lower respiratory tract diseases, such as chronic obstructive lung disease or emphysema
3. Nasal abnormalities or other nasal pathology, such as irreversible nasal mucosal hypertrophy or severe nasal septum derivation
4. Pregnancy or lactation
5. History of alcohol abuse (regularly consumes 5 or more alcohol drinks per day) and/or drug abuse during the 12 month period immediately preceding study enrollment
6. Daily smoking within the past 2 years
7. Use of investigational product or participation in a device trial during the 30 day period immediately preceding study enrollment
8. Previous participation in an experimental study with rhinovirus 39
9. Allergy to any ingredient in the study product
10. Have, as determined by the investigator and/or the sponsor's medical monitor, any surgical or medical condition or take any medication or dietary supplement that could interfere with the interpretation of study results or jeopardize the safety of the subject

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia, Respiratory Disease Study Center
state: Virginia
Study officials:
affiliation: University of Virginia Health System
name: Birgit Winther, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01941017: Evaluation of the Ovarian Reserve in Infertile Patients With Endometriosis
Official title: Evaluation of the Ovarian Reserve in Infertile Patients With Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group I : patients with minimal or mild endometriosis (I or II) as proven by laparoscopy (n=20).

Group II: (control group) patients with tubal obstruction without endometriosis (n=20).

Brief summary: Comparison between Ovarian reserve markers in patients with minimal/mild endometriosis and patients with tubal factor infertility

Detailed description: Comparison between Ovarian reserve markers (laboratory or us) in patients with minimal/mild endometriosis and patients with tubal factor infertility including:

Cycle Day 2 or 3 FSH and E2, Serum AMH and antral follicular count

Eligibility criteria: Inclusion Criteria:

Age 18-35 years of age. Written and signed informed consent by the patient to participate in the study. Patients with regular menses, both ovaries, serum TSH within normal range, body mass index (BMI) \<30 kg/m2 with normal sperm analysis of the husband.

Exclusion Criteria:

Patients with previous endocrine disorders. Cases in which the cause for infertility was other than endometriosis (except for patients with tubal obstruction, in the control group).

Patient with previous surgery for endometriosis.

Primary outcomes:
measure: Assessment of ovarian reserve in the 2 groups
timeFrame: 2 years
Secondary outcomes:
measure: Other Hormonal parameters
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03316417: Study of Adverse Renal Effects of Immune Checkpoints Inhibitors
Official title: Adverse Renal Effects of Immune Checkpoints Inhibitors (Nivolumab, Pembrolizumab, Atezolizumab and Ipilimumab) in Clinical Practice: a Large Monocentric Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Effect
Renal Toxicity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with Immune Checkpoints inhibitors treatment (Nivolumab, Pembrolizumab, ipilimumab, Atezolizumab), for dermatologic, pneumologic, or oncologic cancer treated on Centre Hospitalier Lyon Sud are included.

Brief summary: Renal toxic events related to Immune Checkpoints Inhibitors therapy (Nivolumab, Pembrolizumab, Atezolizumab and Ipilimumab) have been recently reported. These were immune-allergic acute interstitial nephritis.

However, no systematic study has ever focused on renal adverse effects. The investigators study here the evolution of renal function and the occurrence of nephrological events in a large monocentric cohort of patients treated with Immune Checkpoints Inhibitors in the Centre Hospitalier Lyon Sud. Nephrological parameters based on Serum Creatinine (SCr), estimate Glomerular Filtration Rate (eGFR) and urinary sediment are monitored. The aim of the study is to determine the incidence of renal events due to Immune Checkpoint Inhibitor treatment, particularly Acute Kidney Injury, (AKI) and identify the clinical presentation, histological description and risk factors.


Eligibility criteria: Inclusion Criteria:

All patients treated by one of the Immune Checkpoints inhibitors (Nivolumab, Pembrolizumab, ipilimumab or Atezolizumab), for neoplastic pathology in dermatologic, pneumologic, or medical oncology department.

Exclusion Criteria:

* Minor patients (less than 18y).
* Refusal to consent.
* For statistical analysis: Acute Renal Failure caused by another identified etiology than drug toxicity.

Primary outcomes:
measure: Incidence of Acute kidney Injury
timeFrame: maximum 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Department of Nephrology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT00921817: Body Composition in Infants and Children
Official title: Validation of a Body Composition Method for Infants and Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: healthy children
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy children weighing between 0 and 110 pounds

Brief summary: This study will test a new method for measuring body fat and muscle in infants and children: QMR.


Eligibility criteria: Inclusion Criteria:

* healthy child
* weighing between 0 and 110 pounds

Exclusion Criteria:

* child has condition that may affect growth or bone development
* child has chronic disease
* child has disorder of carbohydrate metabolism
* child takes medication that could affect bone density
* child has any type of nonremovable metal

Primary outcomes:
measure: Body Composition
timeFrame: one-time visit
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Aline Andres, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03754517: Finding the Latent Treponema Pallidum
Official title: Finding the Latent Treponema Pallidum of Syphilis With Serofast Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syphilis
Keywords: syphilis
serofast
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All syphilis cases.

Brief summary: Some syphilitic patients remain in a serologically positive state after the recommended therapy. Whether a serofast state could represent a persistent low-level infection by Treponema pallidum is still unknown. The possibility that persistent nontreponemal antibodies after treatment represent persistence of Treponema pallidum was raised by some investigators. The investigators use the Next-Generation Sequencing to test blood plasma, srum, cerebrospinal fluid, aqueous humor, lymph nodes, skin lesion, saliva, semen,milk of serofast patient and other positive and negative controls.

Detailed description: Some syphilitic patients remain in a serologically positive state after the recommended therapy. Whether a serofast state could represent a persistent low-level infection by Treponema pallidum is still unknown. The possibility that persistent nontreponemal antibodies after treatment represent persistence of Treponema pallidum was raised by some investigators. The investigators use the Next-Generation Sequencing to test blood plasma, serum, cerebrospinal fluid, aqueous humor, lymph nodes, skin lesion, saliva, semen,milk of serofast patient and other positive and negative controls.

Eligibility criteria: Inclusion Criteria:

* All clinical diagnosis of syphilis cases

Exclusion Criteria:

* Auto-immune disease (such as SLE)
* Lyme disease

Primary outcomes:
measure: the reads of treponema pallidum
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: PekingUMCH
Study officials:
affiliation: Peking Union Medical College Hospital
name: Jun Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02511717: A Trial of Transcutaneous Nerve Stimulation for OAB
Official title: A Randomized Trial of Transcutaneous Nerve Stimulation for Overactive Bladder Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence. This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the treatment of women with clinical symptoms of overactive bladder.


Eligibility criteria: Inclusion Criteria:

1. Female, \>18 years of age, with the clinical diagnosis of overactive bladder.
2. Failure of behavioral measures and pharmacologic therapy to adequately control overactive bladder symptoms.
3. Baseline patient perception of bladder condition score of 2 or higher.

Exclusion Criteria:

1. Current or previous percutaneous or sacral neuromodulation therapy
2. Stress predominant urinary incontinence
3. Newly added bladder medication or dose change with the last 2 months (Tamsulosin, Silodosin, Alfuzosin, Terazosin, Baclofen, Diazepam, amitriptyline, imipramine, DDAVP, tolterodine, oxybutynin, fesoterodine, darifenacin, solifenacin, trospium, mirabegron)
4. Intravesical botulinum toxin use within the last 1 year
5. Implanted pacemaker or defibrillator
6. History of epilepsy
7. Unable or unwilling to commit to study treatment schedule
8. Pregnant, or possible pregnancy planned for the duration of the study period
9. Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma)
10. Documented allergy to patch electrodes or their adhesive
11. Abnormal sensory function of the lower limb
12. Metallic implant within the lower limb

Primary outcomes:
measure: Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)
timeFrame: 12 weeks
Secondary outcomes:
measure: Overactive Bladder Questionnaire Short Form (OAB-q SF)
timeFrame: 12 weeks
measure: Voiding Diary
timeFrame: 12 weeks
measure: 24hr Pad Weights
timeFrame: 12 weeks
measure: Physician Assessment of Treatment Benefit
timeFrame: 12 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: St Josephs Health Care
state: Ontario
Study officials:
References:
Clinical trial NCT04655417: is Ultrasound-guided Foam Sclerotherapy a Cost-effective Alternate for Treatment of Varicose Veins?
Official title: is Ultrasound-guided Foam Sclerotherapy a Cost-effective Alternate for Treatment of Varicose Veins?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pain
Leg Edema
Cost Effectiveness
Cosmesis
Lead sponsor: Combined Military Hospital, Pakistan
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 70
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: . It is the aim of this paper is to discuss our experience of foam sclerotherapy for varicose veins atour hospital

Detailed description: we will manage all patients with vericose veins with injection sclerotherapy and will monitor there response in terms of relive in vsisble veins, swelling and pain.

we also want to evaluate hoe many sessions of injection sclerotherapy are required for complete resolution of symptoms.

Eligibility criteria: Inclusion Criteria:

* All the patients who present with symptomatic varicose veins underwent a duplex scan by radiologist to identify site of reflux and condition of deep veins. If the patient is a candidate for intervention then he is offered surgery or foam sclerotherapy

Exclusion Criteria:

* recurrent and secondary varicose veins

Primary outcomes:
measure: pain by VAS score
timeFrame: 1 MONTH
measure: leg edema
timeFrame: 1 MONTH
measure: cosmesis
timeFrame: 1 MONTH
measure: cost effectiveness
timeFrame: 1 MONTH
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Anum Arif
state: Select A State Or Province
Study officials:
affiliation: Combined military hospital lahore
name: Anum Arif
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01982617: Motivational Interviewing Compared to Psychoeducation for Smoking Precontemplators With SMI
Official title: A Randomized, Controlled Trial of Motivational Interviewing Compared to Psychoeducation for Smoking Precontemplators With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: Transtheoretical Model
Stages of Change
Nicotine Dependence
Severe Mental Illness
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators primary hypothesis was that recipients of the Motivational Interviewing intervention would be significantly more likely than those assigned to the Psychoeducation intervention to demonstrate increased readiness to quit smoking at the end of the intervention and to seek smoking cessation treatment in the one month period following the intervention. We also predicted that the Psychoeducation intervention would result in greater improvements in smoking knowledge.


Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* Had a diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or chronic major depressive disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria
* Smoked at least 10 cigarettes per day
* At baseline, reported not being ready to quit smoking within the next 30 days (i.e., in precontemplation or contemplation stages).

Exclusion Criteria:

-

Primary outcomes:
measure: Readiness to quit (Stage of Change)
timeFrame: 30 days
Secondary outcomes:
measure: Smoking Knowledge
timeFrame: 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford St
state: Massachusetts
Study officials:
References:
Clinical trial NCT03182517: Parathyroid Hyperplasia in Patients With Chronic Kidney Disease.
Official title: Correlation of Parathyroid Hyperplasia by Ultrasound With Clinical and Laboratory Findings in Patients With Chronic Kidney Disease.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic renal diseases

Brief summary: Secondary hyperparathyroidism is an important complication in patient with chronic kidney disease . It is associated with bone complication and an increase in cardiovascular mortality The parathyroid hormone rises in these patients as consequence of low concentration of vitamin D3 ,reduction in quantities of serum calcium, phosphorus retention and reduction of vitamin D receptors sensitive to calcium.


Eligibility criteria: Inclusion Criteria:

* stage 5 chronic renal failure
* dialysis (peritoneal ,or hemodialysis) since 3---5 years

Exclusion Criteria:

* previous of neck surgery.
* Patients refusal to participate in the study or voluntary withdrawal

Primary outcomes:
measure: The percentage of patients with high parathyroid hormone level
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References: