louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02011737: Naftopidil 75mg for Improving Clearance of Urinary Stones
Official title: The Effectiveness and Safety of Naftopidil 75mg for Improving Clearance of Ureteral and Renal Stones After Shockwave Lithotripsy: Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Calculi
Ureter Calculi
Keywords: Medical Expulsive therapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Dong-A ST Co., Ltd.
First posted: 2013-12-13
Enrollment: 130
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
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 Efficacy and Safety of oral intake of Naftopidil 75mg once daily for the improving clearance of ureteral or renal stones.

Detailed description: Prospective, Single-center, Double blind, Randomized controlled trial

Treatment

- Oral Naftopidil 75 mg once daily are given to the patients who are scheduled for shockwave lithotripsy (ESWL) because of ureteral or renal stones.

Follow up Assessments including X-ray(KUB), visual analogue pain scale, are done 2, 4, and 6 weeks after the ESWL.

Eligibility criteria: Inclusion Criteria:

* Radio-opaque (identifiable in KUB) ureter or kidney calculi
* size criteria is from 5mm to 15mm

Exclusion Criteria:

* Symptomatic acute urinary tract infection during the run-in period
* severe hydronephrosis
* 2 or more urinary stones
* Radiolucent (non-visible in KUB) stone
* recent intervention for the urinary stone within 6 month
* Patients who have ureteral stent
* over 2.0 mg/dl of serum creatinine level
* severe hepatic dysfunction
* orthostatic hypotension
* current usage of alpha-adrenergic blocker or calcium channel blocker
* Pregnant or nursing women
* Age under 15 year
* severe or uncontrolled medical conditions

Primary outcomes:
measure: Difference of the treatment success rate in two weeks after ESWL between treatment group and placebo group
timeFrame: 2 weeks after ESWL
Secondary outcomes:
measure: Difference of the treatment success rate after ESWL between treatment group and placebo group
timeFrame: 4, 6 weeks after ESWL
measure: Adverse Event
timeFrame: 2,4,6weeks
measure: pain scale
timeFrame: baseline, 2, 4, 6 weeks
measure: rate of additional intervention
timeFrame: 6 week
Other outcomes:
measure: time to stone expulsion
timeFrame: 2,4,6week
measure: Number of ESWL
timeFrame: 6week
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Deok Hyun Han, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06037837: Improving Surgeon Performance Measures for Robot-Assisted Surgery
Official title: Generalized Robotic Skills Assessment Using Machine Learning-Based Analysis Across Multiple Surgical Specialties
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Surgery
Keywords: Robot assisted surgical procedure
robotic surgery
prostate surgery
kidney surgery
bladder surgery
colon surgery
pancreas surgery
gallbladder surgery
stomach surgery
uterus surgery
lung surgery
Memorial Sloan Kettering Cancer Center
23-094
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgeons who meet the inclusion criteria will be approached by the study team for participation in this study.

Brief summary: The purpose of this study is to develop new tools to understand surgeon performance to improve surgical training and participant outcomes after surgery.


Eligibility criteria: Inclusion Criteria:

* Surgeons who perform robotic surgery for candidate procedures
* Surgeons who perform candidate procedures that are frequently performed by at least three surgeons (to ensure the ability to make adequate comparisons)
* Surgeons who agree to participate in the study

Exclusion Criteria:

* Surgeons who decline to participate in the study

Primary outcomes:
measure: Correlation of Automated Performance Metrics to surgeon experience
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activites)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alvin Goh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01976637: Compression Treatment of Superficial Vein Thrombosis
Official title: Compression Treatment of Superficial Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Erythema
Thrombus Length
Quality of Life
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 80
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: Leg compression is considered the basic treatment for superficial vein thrombosis (SVT). However, its use is more or less based on subjective experience while scientific evidence for its efficacy is lacking. There is one uncontrolled trial reporting improvement of clinical symptoms when patients with SVT were treated with fixed compression bandages.

This study evaluates the efficacy of compression stockings (23-32 mmHg) in the treatment SVT of the legs. The investigators hypothesis is that compression treatment is superior to no compression in alleviating disease related clinical symptoms.


Eligibility criteria: Inclusion Criteria:

* patients with superficial vein thrombosis of the leg,
* thrombus extent of at least 5 cm confirmed by duplex sonography,
* clinical signs of inflammation (pain, erythema)

Exclusion Criteria:

* superficial thrombus distance to the saphenofemoral or saphenopopliteal junction of less than 2cm,
* concomitant deep vein thrombosis,
* thrombophilia,
* active malignoma,
* immobility,
* peripheral arterial occlusive disease,
* superficial vein thrombosis after sclerotherapy
* incision and clot expression
* excessive leg configuration not covered by ready made compression stockings

Primary outcomes:
measure: pain assessed by VAS (cm)
timeFrame: at baseline, week 1, week 2, week 3
Secondary outcomes:
measure: skin erythema (cm2)
timeFrame: at baseline, week 1, week 2, week 3
measure: duplex-sonographic change in thrombus length (cm)
timeFrame: at baseline, week 1, week 2, week 3
measure: quality of life (SF-36)
timeFrame: at baseline and at week 3
measure: amount of analgetics (number of pills)
timeFrame: week 1, week 2, week 3
measure: duplex-sonographic confirmation of deep vein thrombosis
timeFrame: at baseline and at week 3
measure: löwenberg test (mm Hg)
timeFrame: at baseline, week 1, week 2, week 3
Other outcomes:
measure: D-dimer ug/ml
timeFrame: at baseline and at week 3
measure: platelet count
timeFrame: at baseline, day 7 and day14
Locations:
Study officials:
affiliation: Medical University of Vienna, Department of General Dermatology
name: Kornelia Böhler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03205137: Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice
Official title: Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy Based on Database Data in Real-world Japanese Therapeutic Practice
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japan Medical Information Research Institute (JMIRI), Inc. prescription database is used.

Brief summary: The primary objective of this study is to compare the medication adherence measured by PDC of patients with FDC or double-pill combination therapy in real-world Japanese therapeutic practice.The further objective of this study is how much influence the background of patients to the adherence.


Eligibility criteria: Inclusion Criteria:

* Patients with hypertension
* Patients must have their first prescription (defined as index date\*) for telmisartan and hydrochlorothiazide or Micombi® between 01/07/2010 and 28/09/2010
* Patients must have their first prescription (defined as index date\*) for telmisartan and amlodipine or Micamlo® between 10/12/2010 and 09/03/2011
* Patients must have at least 180 days follow up verified by the presence of prescription record

Exclusion Criteria:

* Patients who were under 40 years old at the time of enrolment
* Patients who prescribed the study drugs less than 90 days during a follow up period of 180 days
* Patients whose visits are less than 2 times during a follow up period of 180 days

Primary outcomes:
measure: Proportion of days covered of patients treated with single- and double- combination therapy
timeFrame: 180 days
Secondary outcomes:
measure: Demographic and clinical characteristics of patients treated with single- and double combination
timeFrame: 180 days
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd.
Study officials:
References:
Clinical trial NCT05103137: Post-transition Clinical and Socio-professional Future in Adult Patients With Recurrent Multifocal Chronic Osteitis
Official title: Post-transition Clinical and Socio-professional Future in Adult Patients With Recurrent Multifocal Chronic Osteitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Recurrent Multifocal Osteomyelitis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with CRMO disease started at pediatric age. Patients who agreed to participate to the study (study questionnaires during a telephone interview (SF36, HAQ and questionnaire pre-established for the study)

Brief summary: Chronic Recurrent Multifocal Osteomyelitis (CRMO) is a rare autoinflammatory bone disease in children. Studies evaluating the quality of life of patients with CRMO are small and heterogeneous. A better understanding of the impact of the disease on the quality of life of adult patients with CRMO beginning in childhood would allow better long-term management of these patients. Our study aims are to assess the clinical and socio-professional outcomes of adult patients who started CRMO at pediatric age.


Eligibility criteria: Inclusion Criteria:

* Adult Patient with a CRMO with pediatric-onset disease (\> 18years)
* Patient who was informed and agreed to participate in this study

Exclusion Criteria:

* Patients with Monogenic auto-inflammatory disease associated with osteolytic bone lesions (e.g. interleukin-1 receptor antagonist deficiency)
* Patient with Majeed syndrome
* Patient without sufficient imaging data to confirm the presence of one or more inflammatory lesions
* Patients with incomplete data.
* Patients placed under legal protection, guardianship or curatorship

Primary outcomes:
measure: Impact of the disease on the quality of life of adult CRMO patients with pediatric-onset disease.
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service Rhumatologie Pédiatrique Centre De Référence Maladies Rares RAISE Hôpital Femme Mère Enfant
city: Lyon
country: France
facility: Service de Rhumatologie Centre Hospitalier Edouard Herriot
city: Pierre-Bénite
country: France
facility: Service de Rhumatologie Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT00590915: Erwinase Master Treatment Protocol
Official title: Erwinase Master Treatment Protocol
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Leukemia, Acute Lymphoblastic
Acute Lymphoid Leukemia
Keywords: ALL
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
Collaborators: name: Fisher Bioservices
name: Jazz Pharmaceuticals
First posted: 2008-01-11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to make Erwinase available to patients with acute lymphoblastic leukemia (ALL) who have had previous allergic reactions to certain formulations of L-asparaginase.


Eligibility criteria: Inclusion Criteria:

* Patient must give written informed consent to receive Erwinase.
* Patient must be treated for acute lymphoblastic leukemia.
* Patient must have either systemic hypersensitivity reactions to native (Elspar) or pegylated E.coli asparaginase (Oncaspar). This includes patients with generalized rash with or without anaphylactic symptoms, or patients with previously documented local or systemic reactions to E.coli derived L-asparaginase.

Exclusion Criteria:

* Previous allergic reaction to Erwinia L-asparaginase (Erwinase)
* Previous acute pancreatitis
* Pregnant or lactating woman

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01770015: Bronchial Colonization With Fungi and Late Respiratory Acquired Pneumonia
Official title: Study of the Impact of Bronchial Colonization With Fungi in the Occurrence of Late Ventilator Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Acquired Pneumonia
Keywords: patient ventilated for at least five days
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Ventilator acquired pneumonia (VAP) are severe nosocomial infections. On the other side, bronchial fungi colonization is commonly observed in ICU; therefore, the investigators propose to study the role of bronchial fungi colonization on the occurrence of VAP taking into account the immune status of the patient and the antibiotic and antifungal treatments he has received.


Eligibility criteria: Inclusion Criteria:

* patient ventilated for at least 5 days

Exclusion Criteria:

* invasive infection Candida sp defined by : candidemia, isolation of Candida from a normally sterile site, candida pneumoniae.

Primary outcomes:
measure: Onset of a late ventilator acquired pneumonia (VAP)
timeFrame: Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks
Secondary outcomes:
measure: Onset of a pseudomonas aeruginosa associated VAP
timeFrame: Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks
measure: Onset of late ventilator associated pneumonia associated to staphylococcus aureus
timeFrame: Participants will be followed for the duration of mechanical ventilation, an expected time frame that can go from 5 days to up to 8 weeks
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Hospital University Clermont Ferrand Gabriel Montpied
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: TIMSIT Jean-François, PU/PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Timsit JF, Schwebel C, Styfalova L, Cornet M, Poirier P, Forrestier C, Ruckly S, Jacob MC, Souweine B. Impact of bronchial colonization with Candida spp. on the risk of bacterial ventilator-associated pneumonia in the ICU: the FUNGIBACT prospective cohort study. Intensive Care Med. 2019 Jun;45(6):834-843. doi: 10.1007/s00134-019-05622-0. Epub 2019 Apr 24.
Clinical trial NCT04770415: Ophthalmic Manifestations of Patients With Mucopolysaccharidosis
Official title: Ophthalmic Manifestations of Patients With Mucopolysaccharidosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ophthalmic Manifestations
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 28
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients at any age up to 18 years with any type of MPS

Brief summary: Mucopolysaccharidosis (MPSs) are a group of disorders caused by inherited defects in lysosomal enzymes resulting in widespread intra- and extra-cellular accumulation of glycosaminoglycan(1,2). They have been subdivided according to enzyme defect and systemic manifestations and include MPS IH (Hurler)(3) , MPS IS (Scheie), MPS IH/S (Hurler/Sheie), MPS II(4,5) (Hunter), MPS III (Sanfilippo)(6) , MPS IV (Morquio)(7,8), MPS VI (Maroteaux-Lamy)(9), MPS VII (Sly)(10,11) and MPS IX (Natowicz)(12). Mucopolysaccharidosis have a spectrum of systemic manifestations, including airway and respiratory compromise, skeletal deformities, intellectual and neurological impairment, cardiac abnormalities, gastrointestinal problems and ocular manifestations(13). Ocular manifestation are common in the mucopolysaccharidosis and may result in significant visual impairment(14). Corneal opacification of varying severity is frequently seen, as well as retinopathy, optic nerve swelling and atrophy, ocular hypertension, and glaucoma(14). New treatment modalities for the systemic manifestations of the mucopolysaccharidosis include bone marrow transplant and enzyme replacement therapy have resulted in an improved prognosis in many cases(15).


Eligibility criteria: Inclusion Criteria:

* All patients at any age up to 18 years with any type of MPS confirmed by the enzymatic assay

Exclusion Criteria:

* Any patient other than MPS

Primary outcomes:
measure: early detection and management of ophthalmic manifestations in patients with MPS
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT02980315: A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application
Official title: A New Efficient EBV AssociatedTechnologies of T Cells in Treating Malignant Tumors and Clinical Application
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Nasopharyngeal Neoplasms
Keywords: nasopharyngeal carcinoma
EBV related cancers
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 20
Sex: ALL
Standard ages: CHILD
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 safety of the designed LMP1-CAR -T cells and determine whether the CAR-T cells are effective in the treatment of EBV associated malignant tumors.

Detailed description: Half of the patients will treat with LMP1-CAR-T cells,while the other half will receive a placebo.During the time of the treatment ,we will supervise the side effect of treated group.At last we compare the survival rate and health condition of the two groups.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of nasopharyngeal carcinoma

Exclusion Criteria:

* •pregnant woman

  * severe autoimmune diseases
  * serious infection

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: SecondNanjingMU
state: Jiangsu
Study officials:
References:
Clinical trial NCT01010815: Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis
Official title: Metagenomic Analysis of Gut Microbiome in Korean Patients With Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis
gut microbiome
metagenomics
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2009-11-10
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: gastroenterology clinic at SNUH(Seoul National University Hospital)

Brief summary: The researchers will investigate gut microbiome in Korean patients with ulcerative colitis and normal control subjects using metagenomic analysis to elucidate the significant difference between two groups This study will help to understand the association between gut microbiome and inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* Between the age of 19 and 75 years
* willing to consent/undergo necessary procedures
* clinically active or inactive Ulcerative colitis

Exclusion Criteria:

* Inability to provide informed consent or
* Clinically severe or fulminant ulcerative colitis
* Previous abdominal surgery
* Pregnancy
* Clinically or laboratory-confirmed gastroenteritis for at least 3 months before sampling
* the use of antibiotics in the past a month before sampling
* the use of probiotics in the past a month before sampling
* Severe cardiovascular or pulmonary disease
* Severe convulsive disorder and current use of anti-convulsive medication
* Malignancy
* Transplantation

Primary outcomes:
measure: characterize the difference in gut microbiomes through metagenomic analysis between UC patients and normal control subjects
timeFrame: 1 year
Secondary outcomes:
measure: characterize the difference in gut microbiomes through metagenomic analysis between stool specimens and biopsy specimens in participants with UC and normal subjects
timeFrame: 1 year
measure: characterize the difference in gut microbiomes among colonoscopy biopsy locations (rectum, ascending and descending colon)
timeFrame: 1 year
measure: characterize the difference in gut microbiomes between active and inactive UC patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Joo Sung Kim, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: