louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00889304: Position HTO Multicenter NIS
Official title: Study on Quality of Life in Patients With Unicompartmental Arthrosis After High Tibial Osteotomy With the Position HTO(R) System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medial Monocompartmental Osteoarthritis of the Knee
Keywords: HTO, high tibial osteotomy, open wedge, medial arthritis
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2009-04-28
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients

Brief summary: Evaluation of the Position HTO system in patients with unicompartmental medial arthrosis after open wedge high tibial osteotomy


Eligibility criteria: Inclusion: Varus deformity between 0 - 20°, Isolated medial arthrosis ≥ level 2 (K\&L) OR a congenital deformity OR chondromalacia ≥ level 2 (ICRS), Lateral cartilaginous tissue damage ≤ level 1(K\&L), Intact lateral meniscus, Age ≥ 18 years, Range of Motion at least 0° - 0° - 130°, Patella/ sliding plane without signifikant signs of arthrosis, Stable joint OR possibility of intraoperative balancing of the tendon tension;

Exclusion: Clinically relevant disorders of bone metabolism, Aktive infection, Adipositas (BMI ≥ 35), Rheumatoid arthritis, Osteomyelitis in the tibia, No availibility for follow-up examinations

Primary outcomes:
measure: Patient health status improvement assessed by IKDC 2000 subjective knee score
timeFrame: 1 year after HTO
Secondary outcomes:
measure: Improvement of further scores: Tegner Activity Score, Lysholm-Gillquist Score, Cincinnati-Sportsmedicine and Orthopaedic Center-Score, IKDC 2000 objective knee score, Hospital for Special Surgery Score (HSS)
timeFrame: 1 year after HTO
Other outcomes:
Locations:
city: Bad Aibling
country: Germany
facility: Orthopädie Harthausen
city: Bad Mergentheim
country: Germany
facility: Caritas-Krankenhaus Bad Mergentheim
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Rottenburg
country: Germany
facility: Winghofer Medicum
city: Tübingen
country: Germany
facility: BGU Tübingen
Study officials:
affiliation: Winghofer Medicum
name: Jürgen Fritz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01005004: Study of Human Central Nervous System (CNS) Stem Cells Transplantation in Pelizaeus-Merzbacher Disease (PMD) Subjects
Official title: Phase I Study of the Safety and Preliminary Efficacy of Intracerebral Transplantation of HuCNS-SC® Cells for Connatal Pelizaeus-Merzbacher Disease (PMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pelizaeus-Merzbacher Disease
Keywords: PMD
stem cells
Pelizaeus-Merzbacher Disease
human stem cells
central nervous system stem cells
Lead sponsor: StemCells, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-30
Enrollment: 4
Sex: MALE
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine the safety and preliminary effectiveness of human central nervous system stem cells (HuCNS-SC®) transplantation in patients with Connatal Pelizaeus-Merzbacher Disease (PMD).

Detailed description: Enrolled subjects will be transplanted with HuCNS-SC cells into the brain and will receive immunosuppression for nine months. The study observation period is for one year after transplant surgery. Thereafter, subjects will be enrolled in a long-term observational follow-up study for four years.

Eligibility criteria: Inclusion Criteria:

* Confirmed clinical diagnosis of connatal PMD
* Molecular genetic confirmation of mutation in the proteolipid protein 1 (PLP1) gene
* MRI consistent with PMD as interpreted by a qualified neuroradiologist

Exclusion Criteria:

* Other significant congenital brain abnormality not related to PMD
* Previous participation in gene transfer or cell transplant trial
* Presence of neurological signs and symptoms not consistent with PMD
* Current or prior malignancy
* Prior organ, tissue or bone marrow transplant

Primary outcomes:
measure: Safety assessment through clinical neurological and MRI evaluation.
timeFrame: one year post transplant
Secondary outcomes:
measure: MRI examination for post-transplant myelination
timeFrame: one year post transplant
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: StemCells, Inc.
name: Stephen Huhn, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05605704: Olive Leaf Extracts in the Control of Diabet
Official title: Efficacy of a Treatment Based on Olive Leaf Extracts in the Control of Diabet
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
Atherolive
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In each study population, the patient will be assigned to one of two treatments (atherolive or placebo) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.
Primary purpose: PREVENTION

Brief summary: This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).

Patients over 18 years of age with:

-Diabets

Detailed description: This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).

All the population will benifit of a biological assessment which include:

* Complete lipid profile, blood sugar, creatinine
* HbA1c (if the patient is diabetic).
* Inflammatory assessment: reactive protein C One population will be rendomized:The population with diabetes. In each study population, the patient will be assigned to one of two treatments (atherolive or placebo). The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.

Continuous blood glucose monitoring to measure indices of glycemic variability is performed at baseline. These patients will be equipped with an iPro continuous glycemic monitoring

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age with:
* diabetes.

Exclusion Criteria:

* Exclusion criteria: None.

Primary outcomes:
measure: rate of continuous glycemic monitoring and Hemoglobin A1C
timeFrame: 90 days
Secondary outcomes:
measure: variation in lipid balance
timeFrame: 90 days
measure: rate of hospitalization for cardiovascular disease and adverse effects
timeFrame: 90 days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Semir Nouira
state: Monastir Tunisia
Study officials:
affiliation: University of Monastir
name: Nouira Semir, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00732004: Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Clinical Vision Research Australia
name: Alcon Research
First posted: 2008-08-11
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The principal aim of this project is to determine the time course of development of contact lens and contact lens case contamination during daily wear of silicone hydrogel lenses. The secondary aim of the study is to determine whether the time course of development of contact lens and contact lens case contamination varies between two different contact lens care systems.


Eligibility criteria: Inclusion Criteria:

* Distance contact lens prescription between +8.00 and -10.00D.
* Cylindrical component of refractive error no greater than 1.25D in either eye.
* Vision correctable to 6/12 (0.30 logMAR) or better in each eye.
* Healthy normal eyes without anterior segment infection, inflammation or abnormality, or significant slitlamp findings.

Exclusion Criteria:

* Concurrent ocular medication
* Eye injury or surgery within twelve weeks immediately prior to enrolment.
* Current ocular irritation that would preclude contact lens fitting.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Pregnant, lactating or planning a pregnancy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Clinical Vision Research Australia
state: Victoria
Study officials:
References:
Clinical trial NCT05795504: Resistive Exercise Versus HIIT on Calcium and Vitamin D
Official title: Resistive Exercise Versus High Intensity Interval Training on Calcium and Vitamin D in Premenopausal Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Vitamin D Deficiency
Calcium
Premenopause
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A comparison between resistive exercise and high intensity interval trainig on calcium and vitamin d in premenopausal women.

Detailed description: A total of 57% of women were vitamin D deficient with higher vitamin D deficiency found among premenopausal women (64.7%). Concentrations of 25(OH) D, defined as severely deficient (\< 12 ng/ml), deficient (12-19 ng/ml), insufficient (20-30 ng/ml) and sufficient (\> 30 ng/ml). Both severe vitamin D deficiency and calcium deficiency was significantly more frequent in premenopausal women compared to postmenopausal women. So, it is important to find effective therapeutic approaches to treat vitamin D deficiency among these women

Eligibility criteria: Inclusion Criteria:

* Premenopausal women having reduced calcium level (less than 500mg) intake as recorded by 24 hours' dietary recall method and vitamin D deficiency (12-19 ng/ml).
* Their ages will range from 40 to 45 years.
* Their BMI will range from 25-30 kg/m2.
* Don't receive hormonal replacement therapy.

Exclusion Criteria:

* Smoking.
* History of chronic disease (uncontrolled hypertension, diabetes mellitus)
* Osteoporosis.
* severe musculoskeletal disorders
* cardiovascular disease, thyroid dysfunction

Primary outcomes:
measure: Vitamin D serum level
timeFrame: three months
measure: serum calcium level
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
affiliation: faculty of physical therapy
name: Mai shehata
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01604304: Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi
Official title: Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy
Keywords: stone
calculi
kidney
renal treatment
flexible ureteroscopy
extracoporeal shockwave lithotripsy
retrograde intra renal surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 30
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: Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. There is no prospective randomized study comparing these two treatments. Our study will define with a good level of evidence which technique is the best with regard to the stone free rate, secondary procedure rate and adverse effect.


Eligibility criteria: Inclusion Criteria:

* Patient with 5 to 20 mm renal stone
* Age ≥ 18 years old
* Patient agreement signed
* BMI \< 35
* Contraception

Exclusion Criteria:

* Pregnancy
* Severe musculoskeletal deformities
* Renal artery or aorta aneurysm
* Pacemaker
* Anesthesia contra indication
* Psychiatric trouble or law protection

Primary outcomes:
measure: Stone free rate
timeFrame: Three months
Secondary outcomes:
measure: Stone free rate in weight's sub group
timeFrame: 3 months
measure: Stone free rate in sub group depending on stone diameters
timeFrame: 3 months
measure: Secondary procedure rate
timeFrame: 3 months
measure: Serious and non serious adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service d'urologie, Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: Xavier Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ravier E, Abid N, Ruffion A, Fassi-Fehri H, Buron C, Ganne C, Mallet A, Martin X. [Effectiveness of flexible ureteroscopy versus extracorporeal shock wave lithotripsy for kidney stones treatment]. Prog Urol. 2015 Apr;25(5):233-9. doi: 10.1016/j.purol.2015.01.005. Epub 2015 Jan 29. French.
Clinical trial NCT04771104: The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy
Liver Cirrhosis
Sleep Disturbance
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Sleep disturbances are common among patients with liver cirrhosis, but the reasons are not well understood. In this project the investigators evaluated whether an increase in blood ammonia in patients with cirrhosis had an impact on sleep quality and the function of retinal ganglion cells measured by pupillary response to blue light.


Eligibility criteria: Inclusion Criteria:

* Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis
* Written informed consent
* \>20 and \<80 years of age

Exclusion Criteria:

* Misuse of alcohol in the preceding 6 months,
* Episodes of hepatic decompensation leading to in-patient admissions during the previous month
* History or clinical signs of overt HE or severe sleep-wake disturbances
* On anti-HE treatment (lactulose, rifaximin, Hepa-Merz, Generaid, Bramino)
* History of significant head injury
* Neurological/psychiatric comorbidity needing medical treatment
* Taking neuroactive medication/medication known to affect sleep
* Travel across more than two time zones in the preceding 3 months
* Shift work in the preceding 5 years
* Contraindications for arterial puncture (negative collateral circulation test, wrist infection or vascular abnormalities).

Primary outcomes:
measure: Difference in the late post-illumination pupillary response after intervention compared to placebo
timeFrame: 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of gastroenterology and hepatology, Rigshospitalet
Study officials:
References:
citation: Kann AE, Ba-Ali S, Seidelin JB, Larsen FS, Hamann S, Bjerring PN. The effect of induced hyperammonaemia on sleep and melanopsin-mediated pupillary light response in patients with liver cirrhosis: A single-blinded randomized crossover trial. PLoS One. 2022 Sep 28;17(9):e0275067. doi: 10.1371/journal.pone.0275067. eCollection 2022.
Clinical trial NCT02714504: Anti-mold Azole in the Prophylaxis for Invasive Fusariosis
Official title: Evaluation of the Efficacy of Anti-mold Azole Prophylaxis in High-risk Hematologic Patients With Baseline Superficial Skin Lesions Positive for Fusarium Spp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fusariosis
Onychomycosis
Keywords: Prophylaxis
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 239
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened with dermatologic examination. In the presence of any skin lesion in the extremities, direct exam and fungal culture will be performed. If these exams indicate the presence of Fusarium species, patients will receive anti-mold azole prophylaxis

Detailed description: Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened on admission. Patients may be included more than once, provided that a new treatment is administered and \>30 days elapses from one to other admission (episode).

Screening will consist of a thorough physical examination in the extremities. In case of a skin lesion, direct exam and fungal culture will be performed. Nail samples will be obtained by scrapping the nails with a curette, and samples from interdigital areas will be obtained using swabs.

In a first phase no intervention will be performed. In a second phase, if direct exam and /or culture indicate the presence of Fusarium spp., primary antifungal therapy with an anti-mold azole (voriconazole (200 mg BID) or posaconazole (200 mg TID) will be started.

Patients will be followed until discharge. The primary endpoint is invasive fusariosis, comparing the observational period with the intervention period.

Eligibility criteria: Inclusion Criteria:

* admission for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia

Exclusion Criteria:

* prior documentation of invasive fusariosis or allergy to azoles

Primary outcomes:
measure: Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery
timeFrame: Until neutrophil recovery, for an average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
state: RJ
Study officials:
References:
Clinical trial NCT04157504: Evaluation of Physical Functions in Lower Limb Burn Injury
Official title: Clinical Factors Affecting Physical Functions in Lower Limb Burn Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Burn Scar
Lower Limb Injury
Lower Limb Wound
Keywords: Burn Injury
Balance
Lower extremity function
burn scar
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study evaluates scar tissue, normal range of motion of lowr extremity joints, lower extremity functions, functional capacity, functional mobility, kinesiophobia and quality of life in lower limb burn injury.

Detailed description: Patients with lower extremity burns experience problems with range of motion, muscle strength, balance and gait. These problems contribute to prolonged physical disability, return to work or deterioration of work capacity and thus lead to a negative impact on quality of life.

In addition to studies showing that quality of life and functions may be affected adversely after burn, there are studies showing that burn percentage, health-related quality of life and functional outcomes are affected. The aim of this study is to determine the effects of burn area (with or without joint), percentage of burns and hypertrophic scar on the patient's function in patients with lower extremity burns.

Eligibility criteria: Inclusion Criteria:

* Having a lower limb burns
* To be a volunteer to participate

Exclusion Criteria:

* orthopedic problems affecting gait and stance
* Having a neurological disorders
* Walking with assist device

Primary outcomes:
measure: Lower Extremity Function
timeFrame: 10 minutes
measure: Nottingham health profile
timeFrame: 10 minutes
Secondary outcomes:
measure: scar tissue assessment
timeFrame: 10 minutes
measure: Tampa kinesiophobia scale
timeFrame: 10 minutes
measure: Six minutes walk test
timeFrame: 10 minutes
measure: Timed up and go test
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ozden Ozkal
Study officials:
References: