louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04752995: Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum
Official title: Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum: Improving the Technique and Managing Potential Complications.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deformity Knee
Deformity of Limb
Keywords: Genu varum, mini-invasive, osteotomy, osteoclasis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 70
Sex: ALL
Minimum age (years): 36
Maximum age (years): 52
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective randomized study
Primary purpose: TREATMENT

Brief summary: Genu-varum is a common problem encountered in pediatric orthopedic. Correction of pathological deformity is mandatory to ensure normal load transfer through the knee. In this study, the investigators describe a new technique of osteotomy osteoclasis in order to evaluate if it is an effective and reliable method in management of infantile genu varum

Detailed description: Seventy children with 122 legs suffering significant infantile genu-varum were treated by percutaneous osteotomy-osteoclasis technique. The mean age was 46 months. Genu varum was bilateral in 52 children and unilateral in 18 with a mean preoperative proximal medial tibial angle 66.67 ± 2.670. Under general anesthesia, transverse osteotomy osteoclasis was performed below the tibial tuberosity. Follow-up radiograph was done within the first post-operative week and then every two weeks to assess alignment and consolidation.

Eligibility criteria: Inclusion criteria:

* Infantile genu-varum
* PMTA≤70 not spontaneously corrected

Exclusion criteria:

* Active rickets or other metabolic disease
* Patients in whom the femur or the joint is the main site of the deformity

Primary outcomes:
measure: proximal medial tibial angle
timeFrame: one year
measure: the posterior proximal tibial angle
timeFrame: one year
measure: Self-Administered Patient Satisfaction Scale
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rab GT. Oblique tibial osteotomy revisited. J Child Orthop. 2010 Apr;4(2):169-72. doi: 10.1007/s11832-009-0228-z. Epub 2009 Dec 20.
Clinical trial NCT02024295: Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
Official title: Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis, Alcoholic
Lead sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-31
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.

Detailed description: randomize first time for core treatment stage for 6 weeks, then randomized second time for extend treatment for 42 weeks.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index range 19-30kg/m2
* Alcohol Drinking history more than 5 years, for male ≥ 40g/ day, for female ≥ 20g/ day;
* STB from 2 to 10X ULN;
* ALP\>1.5X ULN or GGT\>3X ULN

Exclusion Criteria: any one of below,

* active virus hepatitis, or anti-HIV(+)
* exclude other hepatic disease: non-alcoholic fatty liver, drug-induced liver injury, autoimmune hepatitis( AMA/ANA\>1:100), Wilson disease, hemochromatosis or other hepatic disease; obstructive cholestasis
* other non-hepatic diseases caused jaundice
* primary hepatic carcinoma

Primary outcomes:
measure: response rate of serum total bilirubin
timeFrame: 6 weeks
Secondary outcomes:
measure: level of serum direct bilirubin
timeFrame: 6 weeks and 48 weeks
measure: level of serum bile acids
timeFrame: 6 weeks and 48 weeks
measure: level of glutamic pyruvic transaminase
timeFrame: 6 weeks and 48 weeks
measure: level of glutamic oxaloacetic transaminase
timeFrame: 6 weeks and 48 weeks
measure: level of alkaline phosphatase
timeFrame: 6 weeks and 48 weeks
measure: level of gamma-glutamyl transpeptidase
timeFrame: 6 weeks and 48 weeks
measure: level of hyaluronic acid
timeFrame: 6 weeks and 48 weeks
Other outcomes:
measure: Liver biopsy
timeFrame: 48 weeks
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Beijing
country: China
facility: Jun Cheng
state: Beijing
Study officials:
affiliation: Beijing Ditan Hospital affiliated ffiated to Capital Medical University
name: Jun Cheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00663195: Effects of Spironolactone on Matrix Metalloproteinases (MMPs) in Heart Failure
Official title: Effects of Spironolactone on Circulating MMPs in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Stable Heart Failure
Keywords: heart failure
fibrosis
MMP
spironolactone
furosemide
Lead sponsor: Tottori University Hospital
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels and insulin resistance in patients with chronic heart failure.

Detailed description: Myocardial fibrosis is observed in failing hearts. MMPs are considered markers of fibrosis. Recently, circulating MMPs can be measured and are elevated in patients with chronic heart failure (CHF). It has been reported that spironolactone improves myocardial fibrosis in CHF animal models. Therefore, the purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels in patients with chronic heart failure.

Eligibility criteria: Inclusion Criteria:

* chronic stable heart failure

Primary outcomes:
measure: MMP levels
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03712995: Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf
Official title: Reconstruction of Upper Eyelid Defects Secondary to Malignant Tumors With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reconstructive Surgical Procedure
Keywords: Cutler-Beard
tarsoconjunctival graft
upper eyelid
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Retrospective review of charts of the patients enrolled
Primary purpose: TREATMENT

Brief summary: To study the results of a modified Cutler-Beard technique , using a contralateral tarsoconjunctival graft, in patients who underwent excision of large malignant tumors of the upper eyelid

Detailed description: A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described.

Functional, cosmetic outcomes and postoperative complications were evaluated.

Eligibility criteria: Inclusion Criteria:

* Upper eyelid defect after tumor resection

Exclusion Criteria:

* previous surgery

Primary outcomes:
measure: Eyelid retraction
timeFrame: 42 months
Secondary outcomes:
measure: Retraction of the donor lower eyelid
timeFrame: 42 months
measure: Lagophthalmos
timeFrame: 42 months
measure: Lid margin stability
timeFrame: 42 months
measure: Eyelid status
timeFrame: 42 months
Other outcomes:
measure: Symptoms of the patients
timeFrame: 42 months
Locations:
Study officials:
affiliation: Hospital Universitario 12 de Octubre, Madrid, Spain
name: Enrique Mencía-Gutiérrez, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00538395: Intensive Sequential Chemotherapy With Adriamycin Taxol and Cytoxan in the Treatment of Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intensive sequential chemotherapy with Adriamycin Taxol and Cytoxan in the treatment of locally advanced breast cancer


Eligibility criteria: Inclusion Criteria:

* Patients with locally advanced breast cancer

Primary outcomes:
measure: Effectiveness
timeFrame: overall
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: KFSH&RC, Riyadh, Saudi Arabia
name: Adnan Ezzat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02860195: Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration
Official title: Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Sweat Alcohol Concentration
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A non invasive transdermal sensor device was developed by the Im2Np laboratory to determine the presence of vapor of alcohol in insensible perspiration.

One of possible application would be a continuous and non invasive monitoring of drinking behavior. To investigate the validity of this method, it's necessary to compare Transdermal Alcohol Concentrations results obtained by this new device with Blood Alcohol Concentrations and breath Alcohol Concentrations provided by reference methods.

The purpose of this study is to identify the kinetic of alcohol concentration in blood, exhaled air and sweat after alcohol ingestion.


Eligibility criteria: Inclusion Criteria:

* Male or female 18-40 years, age-matched (+ 3 years)
* Caucasian
* BMI: 19 to 28 kg/m2
* No smoking or light smoker (\<5 cig/d)
* Moderate consumer of alcohol (3-14 drinks/week), with the intoxicated experience

Exclusion Criteria:

* Subjects with addiction to toxic or alcohol (MINI Questionnaire)
* Positive individuals in search of drugs and toxic
* Anxiety or depressive subjects (IASTA Questionnaires and BDI)

Primary outcomes:
measure: The determination of ethanol in the plasma
timeFrame: 6 months
Secondary outcomes:
measure: measures in the exhaled air
timeFrame: 6 months
measure: sweat alcohol concentration
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
affiliation: ASSISTANCE PUBLQIUE HOPITAUX DE MARSEILLE
name: OLIVIER BLIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02155595: Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy
Official title: Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Atypical Femoral Fractures
Prodromal Bone Deterioration
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2014-06-04
Enrollment: 738
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be found within the Henry Ford Health System Division of Endocrinology, Diabetes, Bone \& Mineral Disorders

Brief summary: The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called "bisphosphonates", colloquially referred to as Alendronate, risedronate, Ibandronate, and Zoledronate.

In addition, the study is designed to find out which patient is most likely to develop this potential life changing complication and why. Finally, the results of this study will help clinicians to better understand the reason and thus tailor patient specific treatments...i.e., "the right treatment for the right patient for right duration."


Eligibility criteria: Inclusion Criteria:

* women with a diagnosis of osteopenia or osteoporosis as defined by Bone Mineral density (BMD)
* patient treated with BPs for \>5 years
* patients treated with non-BP anti-fracture medications such as...
* estrogens, raloxifene, calcitonin
* treatment naive patients

Exclusion Criteria:

* all men regardless of BMD result
* patients with obvious traumatic AFF
* patients with normal BMD (better than -1.0 T-score at spine or proximal hip)
* unable to take tetracycline
* previous use of teriparatide
* known allergies to the following:
* tetracycline antibiotics
* meperidine
* midazolam

Primary outcomes:
measure: Prodromal bone deterioration (PBD)
timeFrame: 5 years
Secondary outcomes:
measure: Diagnosis of PBD
timeFrame: 5 years
Other outcomes:
measure: Osteocyte lacunae
timeFrame: 5 years
Locations:
city: Detroit
country: United States
facility: Henry Ford Medical Center, New Center One
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Sudhaker D. Rao, M.B;B.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farlay D, Rizzo S, Ste-Marie LG, Michou L, Morin SN, Qiu S, Chavassieux P, Chapurlat RD, Rao SD, Brown JP, Boivin G. Duration-Dependent Increase of Human Bone Matrix Mineralization in Long-Term Bisphosphonate Users with Atypical Femur Fracture. J Bone Miner Res. 2021 Jun;36(6):1031-1041. doi: 10.1002/jbmr.4244. Epub 2021 Feb 11.
Clinical trial NCT04555395: The Differences Between Gonadal and Extra-gonadal Malignant Teratomas
Official title: The Differences Between Gonadal and Extra-gonadal Malignant Teratomas in Both Genders and the Effects of Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SEER Database
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 3799
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The registry used in our study was the SEER 9 registries Custom Data (with additional treatment fields), Nov 2016 Submission (1973-2014) \< Katrina/Rita Population Adjustment\> - Linked to County Attributes -Total United States, 1969-2015 Counties, National Cancer Institute, DCCPS (Division of Cancer Control and Population Sciences), Surveillance Research Program, released April 2017, based on the November 2016 submission.

Brief summary: A tumor comprising of different types of tissues (such as hair, muscle, bone, etc.) is known as a teratoma. It is a type of germ cell (cells that make sperm or eggs) tumor. When these germ cells have rapid cancerous growth, then such a teratoma is called a malignant teratoma. We have studied the differences between gonadal and extra-gonadal malignant teratomas and the effects of chemotherapy in both genders.

Methods: The samples of 3799 male and 1832 female patients with malignant teratoma samples, between the ages of 1 and 85+ years, were selected from the years 1973 to 2014. Trends in incidence, estimated prevalence, incidence rates, and frequency were calculated in gonadal and extra-gonadal tumors with age adjustment. The fiveyear observed, expected, and relative survival rates were analyzed to study the prognosis.


Eligibility criteria: The registry used in our study was the SEER 9 registries Custom Data (with additional treatment fields), Nov 2016 Submission (1973-2014) \< Katrina/Rita Population Adjustment\> - Linked to County Attributes -Total United States, 1969-2015 Counties, National Cancer Institute, DCCPS (Division of Cancer Control and Population Sciences), Surveillance Research Program, released April 2017, based on the November 2016 submission.

Primary outcomes:
measure: survival rates
timeFrame: 1973-2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00374595: Vascular Risk After Kidney Transplantation
Official title: Vascular Risk After Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Chronic Kidney Disease
Diabetes
Vitamin D Deficiency
Hyperparathyroidism
Keywords: Kidney Transplant
Vascular Risk
inflammation
Diabetes
Insulin resistance
Chronic kidney disease
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-09-11
Enrollment: 338
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Transplant Clinic patients

Brief summary: Hypothesis: Nontraditional risk factors, such as inflammation, vitamin D deficiency, elevated PTH, insulin resistance, homocysteine, or uric acid, contribute to cardiovascular disease progression after kidney transplant.

The purpose of this study is to evaluate which traditional and nontraditional cardiovascular disease risk factors best predict progression of cardiovascular disease (CVD) using carotid intima media thickness performed by ultrasound, in kidney transplant patients.

Detailed description: Cardiovascular disease remains the greatest cause of mortality after kidney transplant. Traditional risk factors, such as hypertension, diabetes, hyperlipidemia and smoking, contribute to vascular disease after transplant, but nontraditional risk factors may play a bigger role in vascular disease progression in this setting. This observational study will evaluate nontraditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over time. The study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intima media thickness

Eligibility criteria: Inclusion Criteria:

* Kidney transplant more than 6 months ago
* 19 years or older

Exclusion Criteria:

* Estimated GFR \<30
* Previous small bowel, or lung transplant
* Pancreas transplant less than 6 months ago
* Cancer or any condition that would change weight dramatically in the near future such as malabsorption.
* Willing to return for testing annually for 3 years
* Women who are pregnant

Primary outcomes:
measure: Carotid Intima Media Thickness (CIMT)
timeFrame: 3 years (baseline and three year follow up)
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Jennifer L Larsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01882595: Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient
Official title: Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomized Patients
Keywords: Nebulization aerosol nebulizer tracheostomy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare lung deposition of amikacin in two settings: spontaneously breathing through a tracheostomy cannula and through the mouth.


Eligibility criteria: Inclusion Criteria:

* Patient who were likely to require an elective tracheostomy surgery as part as their head and neck surgery

Exclusion Criteria:

* Allergy to Aminoglycosides
* Patients who received Aminoglycosides treatment less than one month prior the surgery
* Pectoralis major flap reconstruction
* Latissimus dorsi flap reconstruction

Primary outcomes:
measure: Amikacin urinary drug concentration
timeFrame: At each micturition during 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT02038595: The Norepinephrine Transporter: A Novel Target for Imaging Brown Adipose Tissue
Official title: The Norepinephrine Transporter: A Novel Target for Imaging Brown Adipose Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Brown Adipose Tissue
Keywords: brown adipose tissue
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: NYU Langone Health
First posted: 2014-01-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study seeks to assess a novel imaging technique to image brown adipose tissue utilizing the norepinephrine transporter.


Eligibility criteria: Inclusion Criteria:

* age 18-30 yrs
* BMI \< 24 kg/m2
* Caucasian

Exclusion Criteria:

* Current neuro-psychiatric illness
* substance abuse
* medical or neurological illnesses likely to affect physiology or anatomy, i.e., uncontrolled hypertension, cardiovascular disorders
* current pregnancy
* current breast feeding
* suicidal ideation or behavior
* use of medications which potentially affect NET binding within 2 weeks of the PET scans.

Primary outcomes:
measure: detection of brown adipose tissue based on PET imaging
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Robert Sherwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hwang JJ, Yeckel CW, Gallezot JD, Aguiar RB, Ersahin D, Gao H, Kapinos M, Nabulsi N, Huang Y, Cheng D, Carson RE, Sherwin R, Ding YS. Imaging human brown adipose tissue under room temperature conditions with (11)C-MRB, a selective norepinephrine transporter PET ligand. Metabolism. 2015 Jun;64(6):747-55. doi: 10.1016/j.metabol.2015.03.001. Epub 2015 Mar 5.