louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01589705: The Relation Between Uric Acid Level and Endothelial Dysfunction in Patients With Polycystic Kidney Disease
Official title: Endothelial Dysfunction in Patients With Polycystic Kidney Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Polycystic Kidney, Autosomal Dominant
Keywords: Uric acid
polycystic kidney disease
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with early stage(preserved renal function) Autosomal dominant polycystic kidney disease (n = 91) from two academic medical center.We also excluded the patients with a previous diagnosis of hypertension, gout, diabetes, current use of oral antidiabetic medication, insulin, thiazide, allopurinol or uricosuric, or a fasting glucose level 126 mg/dl. In addition, the subjects with a history of smoking or current use of any anti-hypertensive medication and statins were excluded

Brief summary: There are substantial data demonstrating increased endothelial dysfunction, inflammation and oxidative stress in patients with Autosomal dominant polycystic kidney disease (ADPKD), the association between serum uric acid level and endothelial dysfunction has not been elucidated yet in these patients. Therefore, in this study, the investigators aimed to examine the relationship between the uric acid level and the ED in normotensive ADPKD patients with preserved renal function.

Detailed description: This is the first study to evaluate the relationship between uric acid and endothelial dysfunction in patients with early stage ADPKD

Eligibility criteria: Inclusion Criteria:

* ADPKD patients with normal renal function,
* Normotensive ADPKD patients

Exclusion Criteria:

* Patients with impaired kidney function,
* Atherosclerotic disorders,
* Diagnosis of hypertension, gout, diabetes,
* Using of insulin, thiazide, allopurinol or uricosuric drugs

Primary outcomes:
measure: Measurement of asymmetric dimethylarginine (ADMA) and flow mediated dilatation (FMD)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Medical School
Study officials:
affiliation: Erciyes University Medical School
name: Bulent Tokgoz, Professor
role: STUDY_DIRECTOR
References:
citation: Kocyigit I, Yilmaz MI, Orscelik O, Sipahioglu MH, Unal A, Eroglu E, Kalay N, Tokgoz B, Axelsson J, Oymak O. Serum uric acid levels and endothelial dysfunction in patients with autosomal dominant polycystic kidney disease. Nephron Clin Pract. 2013;123(3-4):157-64. doi: 10.1159/000353730. Epub 2013 Jul 25.
Clinical trial NCT02607605: A Prospective, Observational Trial on the Diagnostic and Prognostic of LM
Official title: A Prospective, Observational Trial on the Diagnostic and Prognostic Value of Cell-free DNA in Advanced Lung Cancer With Leptomeningeal Metastases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasms
Meningeal Carcinomatosis
Keywords: lung cancer
leptomeningeal metastases
cell-free DNA
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical symptoms and imaging tests are highly suspicious of advanced lung cancer with leptomeningeal metastases

Brief summary: The primary purpose of this study is to compare the positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid in Advanced lung cancer with leptomeningeal metastases.


Eligibility criteria: Inclusion Criteria:

1. Patient who was confirmed primary lung cancer by pathologic histology or cytology
2. Adult patients (≥18 years and ≤75 years). ECOG Performance Status 0 or 1.Life expectancy of at least 12 weeks.
3. Clinical symptoms and imaging tests are highly suspicious of advanced lung cancer with leptomeningeal metastases
4. Without contraindications to lumbar puncture

Exclusion Criteria:

1. Patients who have primary benign or malignant brain tumor and metastatic malignant brain tumor
2. Patients who have contraindications to lumbar puncture
3. Serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease

Primary outcomes:
measure: positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid
timeFrame: 2 years
Secondary outcomes:
measure: The relationship between the number of cell-free DNA and OS
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University of cancer center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: li-kun Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan W, Gu W, Nagpal S, Gephart MH, Quake SR. Brain tumor mutations detected in cerebral spinal fluid. Clin Chem. 2015 Mar;61(3):514-22. doi: 10.1373/clinchem.2014.235457. Epub 2015 Jan 20.
citation: Newman AM, Bratman SV, To J, Wynne JF, Eclov NC, Modlin LA, Liu CL, Neal JW, Wakelee HA, Merritt RE, Shrager JB, Loo BW Jr, Alizadeh AA, Diehn M. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nat Med. 2014 May;20(5):548-54. doi: 10.1038/nm.3519. Epub 2014 Apr 6.
Clinical trial NCT05749705: Fat to Lean Mass Ratio and Its Effect on Low Back Pain and Permanent Functional Disability.
Official title: Fat to Lean Mass Ratio and Its Effect on Low Back Pain and Permanent Functional Disability.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain, Mechanical
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2023-03-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People who suffer from excess fat mass and their age is over 18 years.

Brief summary: The study was conducted for people who suffer from excess fat mass and their age is over 18 years will be calculated with G\*power will be used body composition analyzer to calculate the percentage of fat.

Detailed description: Cross-sectional study was applied. Data was collected through a questionnaire (oswestry disability index arabic version). Fat percentage was taken by Body composition analyzer.

Eligibility criteria: Inclusion Criteria:

* Excess fat mass
* Age must be over 18 years.

Exclusion Criteria:

* People under the age of 18.
* Low back pain not associated with increased fat mass.

Primary outcomes:
measure: Fat to Lean mass ratio
timeFrame: Immediately after the admission
Secondary outcomes:
measure: Low Back Pain and disability
timeFrame: Immediately after the admission
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Jazan University
state: Gizan
Study officials:
References:
Clinical trial NCT01909505: Comparison of Salivary and Serum Free Testosterone in Normal and Hypogonadal Men
Official title: Comparison of Salivary Testosterone With Serum Free Testosterone Done by Equilibrium Dialysis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Known Androgen Deficiency
Lead sponsor: Saliva Biomarkers, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-26
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty normal males and 20 male subjects, 25 to 65 years of age.

Brief summary: Low testosterone is a common male problem. The diagnosis of low testosterone often requires blood sampling and expensive testing. We want to know if measuring saliva testosterone can be used in place of blood sampling. Study participants will be asked to provide samples of blood and saliva for the measurement of testosterone. These results may lead to the development of a saliva test for testosterone.

Detailed description: Testosterone is required for normal male health that is known to decline in aging or other conditions. Physiologically active testosterone, also known as "free" testosterone, is present as a small percentage of the total blood level, mostly bound to sex hormone binding globulin and albumin. Estimation of serum free testosterone is difficult and costly, requiring equilibrium dialysis of a serum sample. These binding proteins are not normally present in saliva. It is hypothesized that the free fraction of testosterone in blood is in equilibrium with the extravascular space, notably saliva. The sponsor proposes to test this hypothesis by sampling saliva and serum and measuring testosterone. Serum free testosterone will be measured following equilibrium dialysis. To perform this study approximately 40 eugonadal and 20 hypogonadal males will be recruited.

Eligibility criteria: Inclusion Criteria:

* Normal male subjects aged 20-65 years

Exclusion Criteria:

* Women Smokers, HIV positive, diabetes, hepatatis C positive, subjects currently taking testosterone who are unwilling to suspend use for teh duration of the trial, subjects taking aldactone or medicines that may interfere with the protocol

Primary outcomes:
measure: blood and saliva testosterone
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: John's Hopkins University Medical Center
state: Maryland
Study officials:
affiliation: Georgetown University
name: West T Moore, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04360005: Managed Access Programs for ABL001, Asciminib
Official title: Managed Access Programs for ABL001, Asciminib
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Chronic Myeloid Leukemia in Chronic Phase
Keywords: Chronic myeloid leukemia
CML
CML-CP
Asciminib
ABL001
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-04-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this registration form is to list all Managed Access Programs (MAPs) related to ABL001, asciminib


Eligibility criteria: Inclusion Criteria:

1. An independent request was received from a licensed physician.
2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
7. Managed Access provision is allowed per local laws/regulations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02788305: Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy
Official title: Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Induced; Birth
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 144 pregnant women with BMI \>= 30 and 144 pregnant women with BMI \<30, post date \>= 41 wks, not in labor admitted in Kaselaini H for induction of labor.

Brief summary: This study investigate the progression of labour in 144 normal weight pregnant women (BMI \<30) and 144 obese pregnant women (BMI \>30) , not in labor admitted for induction of labor. These women are to be investigated for success of induction of labor.

Detailed description: * This prospective study will be conducted for 144 obese and 144 non obese ), post date (\>41 wks), not in labor.
* Woman is classified as obese if BMI \>=30.
* Prolonged pregnancy was defined as delivery on or after (41+0 weeks) of gestation.
* First informed consent will be obtained.
* Determination of gestational age
* Proper history taking, general and abdominal examinations will be done then digital examination will be performed to determine bishop score.
* And obstetric U/S scan will be done and by which the following data will be obtained :

  * Fetal biometry
  * Fetal heart activity
  * Presentation
  * Localization of the placenta.
  * Amount of amniotic fluid.
  * Exclude multifetal pregnancy.
* Induction of labor will be done using vaginal misoprostol according to the estimated Bishop score.

Eligibility criteria: Inclusion Criteria:

* Pregnant woman.

  * Post date \>= 41 weeks.
  * Absent onset of labor.
  * Patient acceptance to join the study after signing an informed consent.

Exclusion Criteria:

* Placenta previa and or vasa previa.
* Previous caesarean section(CS).
* Multiple gestation
* Any patient who will refuse to be a part of the study.
* Intra- uterine fetal death (IUFD).

Primary outcomes:
measure: route of delivery vaginal or caesarean section.
timeFrame: 48 hours from the start of induction
Secondary outcomes:
measure: maternal haemorrhage
timeFrame: 48 hours from the start of induction
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr wl aini hospitals
state: Greater Cairo
Study officials:
affiliation: KasrElaini Hospital
name: Heba M Marie, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maged AM, El-Semary AM, Marie HM, Belal DS, Hany A, Taymour MA, Omran EF, Elbaradie SMY, Mohamed MAK. Effect of maternal obesity on labor induction in postdate pregnancy. Arch Gynecol Obstet. 2018 Jul;298(1):45-50. doi: 10.1007/s00404-018-4767-8. Epub 2018 Apr 2.
Clinical trial NCT03096405: Impact MRSA -PCR on Patient Management
Official title: Impact MRSA -PCR on Patient Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MRSA Bacteremia
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: every patient hospitalized in St Joseph Hospital with an positive hemoculture to Staphylococcus Aureus Methicillin Sensitive

Brief summary: Staphylococcus aureus represents one of the most met germs, with Escherichia coli, during bacteremia. Microbiologist distinguish at aureus S. two profiles of resistance in beta-lactamines: S. aureus sensitive to the methicillin ( SASM) and the S. aureus resistant to the methicillin ( SARM).

With the implementation of the MALDI-TOF, it is now possible to identify the origin responsible of the bacteremia the day of the positivity of the hemoculture ( J0) and to set up a treatment with adapted antibiotic, which, in the case of a sepsis to aureus S., is the vancomycine. Ye it was demonstrated, that the use of the vancomycine on the SASM increased the average duration of stay and a more important rate of relapse.

The PCR SARM was organized in the GHPSJ in 2014. It allows from the day of the positivity of the hemoculture ( J0), to determine the phenotype of resistance of S. aureus.


Eligibility criteria: Inclusion Criteria:

* Hemoculture positive to Staphylococcus Aureus Methicillin Sensitive

Exclusion Criteria:

* Positive test to Staphylococcus Aureus Methicillin Sensitive but not hospitalized.

Primary outcomes:
measure: Adaptation duration of antibiotherapy
timeFrame: 24 hours
Secondary outcomes:
measure: Mortality
timeFrame: Day 30
measure: average duration of hospitalization
timeFrame: day 30
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Groupe Hospitalier Paris St JOSEPH
name: MIZRAHI Assaf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe Hospitalier Paris St JOSEPH
name: LEMONNIER Alban, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01220505: Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
Official title: A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Deformity
Keywords: scoliosis
kyphosis
spinal deformity
curvature
lordosis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2010-10-14
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects with a spinal defomrity with a Risser score of a minimum of 3 where the physician has determined that the patient requires a spinal fusion of the thoracic or lumbar spine are eligible for entry into the post market surveillance.

Brief summary: The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System.

Detailed description: The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System. We have extended the study tol collect further outcomes data at the 12 month time point.

Eligibility criteria: Inclusion Criteria:

* 200 subjects at 10 clinical centers.
* All subjects undergoing spinal fusion surgery between the levels of T1- Ilium (Thoracic 1 to Ilium)
* All subjects are skeletally mature with spinal deformity.
* Risser score must be ≥ 3.
* Subjects or their representative must be willing and able to give informed consent and assent (if applicable).
* Subjects who do not meet any of the following contraindications: spinal infection or inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal sensitivity, foreign body sensitivity, patients with inadequate tissue coverage over the operative site, open wounds local to the operative area, any case not described in the specific indications

Exclusion Criteria:

* Any subject who does not meet the inclusion criteria

Primary outcomes:
measure: Maintenance of Deformity Correction
timeFrame: 6 months
Secondary outcomes:
measure: Decreased Operative Time
timeFrame: 6 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Orthopedics for Kids, PC
state: Alabama
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Atlanta
country: United States
facility: Children's Orthopedics of Atlanta
state: Georgia
city: Indianapolis
country: United States
facility: Orthopedics Indianapolis, P.C.
state: Indiana
city: Rochester Hills
country: United States
facility: Rochester Hills Orthopedics
state: Michigan
city: San Juan
country: Puerto Rico
facility: Torre Auxillo Mutuo
Study officials:
affiliation: Zimmer Biomet
name: Tammy Stinson
role: STUDY_DIRECTOR
References:
Clinical trial NCT01939405: Children's Use of the Built Environment for Physical Activity
Official title: Use of the Built Environment to Promote Physical Activity in Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Obesity
Overweight
Physical Activity
Built Environment
counseling
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aims are to develop and test the feasibility of a pediatric physical activity intervention that incorporates personal information on use of the built environment, and test the intervention's preliminary efficacy at increasing physical activity. The investigators hypothesize that it will be feasible to incorporate and measure changes in empiric GIS (geographic information system), GPS (global positioning system), and accelerometer feedback in the office setting as demonstrated by: i) Completeness of GPS and accelerometer data collection (primary measure of feasibility), ii) Participation rates among adolescents in the intervention group compared to the control group, and iii) Acceptability to patients as measured by adolescent satisfaction.


Eligibility criteria: Inclusion Criteria:

* Adolescents ages 10-16 years
* BMI \> 85th percentile for age and sex

Exclusion Criteria:

* Physical conditions impairing ambulation
* Adolescents who do not speak English
* Adolescents who have missed more than 2 scheduled doctor's appointments during the past 5 years
* Adolescents who are receiving any other form of physical activity counseling/intervention at the time of enrollment

Primary outcomes:
measure: Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Moderate-to-Vigorous Physical Activity (MVPA)
timeFrame: 4 months from baseline
measure: Sedentary Time
timeFrame: Immediately post-intervention
measure: Sedentary Time
timeFrame: 4 months from baseline
Other outcomes:
Locations:
city: Revere
country: United States
facility: Massachusetts General Hospital Revere HealthCare Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nicolas M Oreskovic, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oreskovic NM, Winickoff JP, Perrin JM, Robinson AI, Goodman E. A Multimodal Counseling-Based Adolescent Physical Activity Intervention. J Adolesc Health. 2016 Sep;59(3):332-337. doi: 10.1016/j.jadohealth.2016.03.012. Epub 2016 May 24.