louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02067650: Ultrasound Findings of Finger, Wrist and Knee Joints in Mucopolysaccharidosis
Official title: Ultrasound Findings of Finger, Wrist and Knee Joints in Mucopolysaccharidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MPS I
MPS IV
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 18
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
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 MPS I and IV

Brief summary: Hardly any imaging studies specifically addressing the articular and periarticular structures in MPS patients are available at this point. The investigators propose to do for the first time a pilot study using musculoskeletal ultrasound in patients with various types of MPS.


Eligibility criteria: Inclusion Criteria

* Diagnosis of Mucopolysaccharidosis
* Ability to collaborate with the ultrasound assessment
* Written informed consent from parents and patients over 14 years of age, assent from children 7 to 14 years

Exclusion Criteria

* Inability to collaborate with the ultrasound assessment
* Acute trauma to a joint that will be assessed in the 3 months preceding the study
* Coexistence of other pathology that is known to affect the respective joints

Primary outcomes:
measure: Power Doppler
timeFrame: one time exam
Secondary outcomes:
measure: Ultrasound scanning technique
timeFrame: one time scan
measure: Findings of synovitis or tenosynovitis
timeFrame: one time scan
measure: Differences between MPS I and IV
timeFrame: one time scan
measure: Differences between ERT and BMT
timeFrame: one time scan
measure: Differences between severe and attenuated phenotypes
timeFrame: one time scan
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Johannes Roth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05680350: Relation Between MicroRNA 203 and 210 and Sparing the Laparoscopic Examination in Cases of Unexplained Infertility
Official title: Plasma Levels of Micro RNA 203 and 210 Might Spare the Exploratory Laparoscopy in Case of un Explained Infertility With Suspected Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility Unexplained
Endometriosis
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study targets to evaluate the role of estimation of plasma expression levels of gene of microRNAs 203 and 210 in helping to diagnose and grade endometriosis. The study included women with unexplained infertility and clinical picture suggestive of presence of endometriosis were divided randomly into two groups: Control and study groups. All patients underwent exploratory laparotomy for diagnosis and grading of endometriosis if present. Patients of study group gave blood samples for estimation of plasma expression levels of microRNA 203 and 210 using qRT-PCR procedure.


Eligibility criteria: Inclusion Criteria:

* 30-45 years old
* Unexplained infertility

Exclusion Criteria:

* Presence of other causes of infertility,
* age out of the predetermined range,
* the presence of immune disorders,
* maintenance on immunosuppressive drugs

Primary outcomes:
measure: grading of endometriosis
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Banha University
state: El- Qalyobia
Study officials:
References:
Clinical trial NCT04917250: GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
Official title: Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extranodal NK/T-cell Lymphoma
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of GPED (gemcitabine, pegaspargase, etoposide, and dexamethasone) regimen in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients


Eligibility criteria: Inclusion Criteria:

Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.

* refractory or relapsed after initial remission, or stage III-IV de novo patients
* PET/CT or CT/MRI with at least one objectively evaluable lesion.
* General status ECOG score 0-3 points.
* The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb\>80g/L, PLT\>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
* Sign the informed consent form

Exclusion Criteria:

Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.

Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.

Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months.

• Other experimental drugs are being used.

Primary outcomes:
measure: overall response rate
timeFrame: 24 weeks ±7 days
Secondary outcomes:
measure: complete response rate
timeFrame: 24 weeks ±7 days
measure: 1-year progression free survival rate
timeFrame: up to 1year after enrollment
measure: 1-year overall survival rate
timeFrame: up to 1year after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
Study officials:
affiliation: Beijing Tongren Hospital
name: Liang Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00690950: A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart
Official title: Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Keywords: BPH
Lead sponsor: Urologic Consultants of Southeastern PA
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 50
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis: Dutasteride will perform better than finasteride in decreasing prostate volume, improving symptoms based on International Prostate Symptom score,and lower pvr based on the scientific information that dutasteride inhibits both Type I and II 5-alpha-reducatase vs. finasteride which only inhibits the Type II enzyme


Eligibility criteria: Inclusion Criteria:

* Male
* Age 50-80
* On finasteride for no less than 12 months
* Willing to undergo all necessary test in the 12 month evaluation

Exclusion Criteria:

* History of medication non-compliance
* Unwillingness to undergo/tolerate 2 blood draws
* Unwillingness to tolerate/undergo 2 TRUSP

Primary outcomes:
measure: Laboratory parameters: including serum testosterone, DHT level and PSA
timeFrame: 12 months
Secondary outcomes:
measure: volume measurements of TRUSP and PVR
timeFrame: 12 months
measure: A decrease in the AUASI
timeFrame: 12 months
Other outcomes:
Locations:
city: Bala Cynwyd
country: United States
facility: Urologic Consultants of Southeastern PA
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01980550: Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy
Official title: Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nicotine Dependence
Lead sponsor: National Institute on Drug Dependence, China
Sponsor class: OTHER
Collaborators: name: Bronx VA Medical Center
First posted: 2013-11-11
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Nicotine replacement treatment (NRT) can be efficacious for smoking cessation, but used by only a minority of smokers in China. Pharmacogenetic matching may improve treatment outcomes for NRT in subgroups of smokers. The investigators evaluated the efficacy and safety of sublingual nicotine tablets (SNT) for smoking cessation and the association of catechol-O-methyltransferase (COMT) genotype with efficacy in this smoking cessation trial among Chinese smokers.

Detailed description: All subjects provided written informed consent after a full explanation of the protocol design.

Eligibility criteria: Inclusion Criteria:

* Subjects motivated to stop smoking and Han Chinese
* aged 20-70 years who lived in the Haidian District of Beijing
* smoke ≥10 cigarettes/day
* have smoked for ≥3 years
* carbon monoxide (CO) level ≥10 p.p.m. in exhaled air

Exclusion Criteria:

* a history of "Diagnostic and Statistical Manual of Mental Disorders-fourth Edition" (DSM-IV) psychiatric disorder
* alcohol abuse and other drug abuse
* with pathological changes in the floor of their mouth
* cardiovascular disease
* taking psychotropic medications
* using other forms of tobacco or any other NRT products during the last 6 months
* pregnant or breast-feeding

Primary outcomes:
measure: Changes in the exhaled carbon monoxide (CO) level during the 12-week study
timeFrame: The first was 1 day before quit day (baseline), followed by visits after 1, 2, 4, 6 and 8 weeks at the end of treatment (EOT), with a final follow-up visit at 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: VA Medical Center，USA
name: xiang y zhang, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02911350: Safety Study of Combination of Hormone Therapy, Paclitaxel and Radiation Therapy to Treat Prostate Cancer
Official title: Phase I Study of Bi-weekly Taxol and Definitive Radiation in Androgen Ablated Locally Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 23
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the combination therapy of Hormone, Paclitaxel and Radiation therapy are effective in treatment of locally advanced prostate cancer


Eligibility criteria: Inclusion Criteria:

* Any one or more of the following characteristics will qualify patient with T2/T3 prostate cancer for eligibility to current study:
* Biopsy proven prostate cancer with Gleason score \> 7
* Pathologic staging TXN1 (on MRI or CT)
* Prostate-specific antigen (PSA) \> 10 ng/ml done within a month prior to study entry (the day of first hormonal ablation) and \> 10 days after prostate biopsy.

In addition patients must also have:

* Performance status \< 2
* Hemoglobin \> 11 grams per deciliter (g/dL), White blood cell (WBC) \> 4000 and platelet count \> 100.000/l
* No evidence of other synchronous primary. Prior malignancies does not exclude if the patient is disease free \> 5 years.
* Prior or concurrent basal cell or non-invasive squamous carcinoma of the skin is eligible and
* Received hormone therapy with any of the following combination for less than 3 months
* Lupron / Flutamide
* Zoladex/ Flutamide
* Lupron/ Casodex
* Zoladex/ Casodex

Exclusion Criteria:

* Clinical stage T1N0, PSA \< 10, and Gleason score less than 7.
* Evidence of distant metastasis
* Previous surgery for prostate cancer (radical prostatectomy).
* Current treatment with ketoconazole, cimetidine or hormone therapy for more than 3 months prior to inclusion in the protocol for prostate cancer
* Major medical or psychiatric illness, which in the investigator's opinion may prevent completion of the study and interfere with follow up.
* Bilirubin \> 1.5
* Prior chemotherapy is not allowed

Primary outcomes:
measure: Maximum tolerated dose (MTD) assessment
timeFrame: 8 weeks
measure: Number of participants with qualitative and quantitative toxicities
timeFrame: up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Perlmutter Cancer Center
name: Nicholas Sanfilippo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00544050: Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
Official title: An Open-Label, Single Dose, Pharmacokinetic Study of 20 mg/kg of Levetiracetam Oral Solution in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Levetiracetam
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study was to document the pharmacokinetic parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg of levetiracetam in epileptic pediatric subjects, aged 1 month to less than 4 years.


Eligibility criteria: Inclusion Criteria:

* male or female between 1 month and less than 4 years
* diagnosis of any type of epilepsy
* at least 5 kg body weight
* using no more than two antieplieptic drugs

Exclusion Criteria:

* a treatable seizure etiology
* epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease
* history of status epilepticus during the 2 weeks prior to the Selection Visit
* history of or the presence of pseudoseizures
* epilepsy surgery within one year prior to the Selection Visit
* on a ketogenic diet
* taking felbamate at the Selection Visit

Primary outcomes:
measure: PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Glauser TA, Mitchell WG, Weinstock A, Bebin M, Chen D, Coupez R, Stockis A, Lu ZS. Pharmacokinetics of levetiracetam in infants and young children with epilepsy. Epilepsia. 2007 Jun;48(6):1117-22. doi: 10.1111/j.1528-1167.2007.01090.x. Epub 2007 Apr 18.
Clinical trial NCT00541450: A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)
Official title: A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of Sitagliptin and MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 and 78 with type 2 diabetes mellitus
* Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3 months

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
* Patient has previously been treated with sitagliptin or has previously been in a study using a DPP-4 inhibitor

Primary outcomes:
measure: Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks
timeFrame: Baseline to 40 weeks
measure: Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks
timeFrame: Baseline and 40 weeks
measure: Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks
timeFrame: Baseline and 40 weeks
measure: Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Perez-Monteverde A, Seck T, Xu L, Lee MA, Sisk CM, Williams-Herman DE, Engel SS, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naive patients with type 2 diabetes. Int J Clin Pract. 2011 Sep;65(9):930-8. doi: 10.1111/j.1742-1241.2011.02749.x.
Clinical trial NCT00473850: Establishing the Genetic Profile of Multiple Hereditary Exostoses (HME) in Families of BC
Official title: Establishing the Genetic Profile of Multiple Hereditary Exostoses (HME) in Families of BC
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Exostoses, Multiple Hereditary
Keywords: DNA sequencing
EXT genes
Hereditary Multiple Exostoses,
also known as Multiple Hereditary Exostoses,
also known as Hereditary Multiple Osteochondromas
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Circle of Care
name: Vancouver Foundation
name: Children's & Women's Health Centre of British Columbia
First posted: 2007-05-16
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Benetic profile of families in British Columbia with HME.

Brief summary: The purpose of this study is to establish the genetic profile of families in British Columbia with HME.

Detailed description: The purpose of this study is to establish the genetic make-up of families and patients with HME. This will occur as the patient presents to a regular clinic visit. Dr. Alvarez will be introduced to interested patients and their parent(s) and a brief discussion about the project will occur. If the patient and their direct family are interested they will be entered into the study. This will involve interviewing the patients and their direct family. This interview will take about 1 hour. We are interested in identifying all affected family members as far up the family tree as possible. We ask that the idea of the study be introduced to extended family members by the participating family members and then have them call Dr. Alvarez to set up an appointment. Each available member will be interviewed and a physical exam done to determine the location of osteochondromas. In addition, Xrays will be done to determine the location of all osteochondromas. All Xrays will be reviewed. No new ones will be taken unless it is part of the patient's routine care.

To complete the genetic work up DNA analysis will be done on all available family members. This will entail obtaining a blood sample from each family member willing to partake in the study. These blood samples will be used only for the purpose of identifying abnormalities in the genes related to osteochondromas. The blood samples will be taken at British Columbia's Children's Hospital and processed there. DNA samples will be kept confidential.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with HME

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Christine Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02085850: Incidence and Progression of Glaucoma in the Tema Eye Survey Cohort
Official title: Incidence and Progression of Glaucoma in the Tema Eye Survey Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Lead sponsor: Tema Christian Eye Center
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 1375
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Aim 1: To determine the incidence of glaucoma in Ghana in subjects previously found to be non-glaucomatous in the Tema Eye Survey.

Aim 2: To characterise the progression of glaucoma and the outcomes of subjects diagnosed with glaucoma in the Tema Eye Survey.


Eligibility criteria: Inclusion Criteria:

- glaucomatous and non-glaucomatous patients previously seen in the Tema Eye Survey who are selected and invited to participate

Exclusion Criteria:

- patients not previously seen in the Tema Eye Survey

Primary outcomes:
measure: Incidence of Glaucoma
timeFrame: Day 0
measure: Progression of Glaucoma
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Tema
country: Ghana
facility: Tema Christian Eye Center
Study officials:
affiliation: Tema Christian Eye Center
name: Alexander Spratt, MBBCh FRCOphth
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Donald L Budenz, MD MPH
role: STUDY_CHAIR
References: