louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02609867: A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)
Official title: A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of 'Flowise Cerebral Flow Diverter' for the Treatment of Unruptured Wide-necked Cerebral Aneurysm in the Internal Carotid Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: 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 safety and short-term effectiveness of implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked cerebral aneurysm in the internal carotid artery.

Detailed description: Flowise is indicated for use in patients with unruptured wide-necked aneurysm in the internal carotid artery. Consecutive subject data should be collected at discharge, 1, 3, and 6 month post Flowise implantation.

Eligibility criteria: Inclusion Criteria:

* Functional neurological state ≤2 mRS
* Unruptured wide-neck aneurysm in the internal carotid artery has a size \>8mm, a neck ≥4mm, or dome/neck ratio \<2
* Parent artery with diameter ≥3.25mm and ≤4.5mm
* Patient willing to provide written informed consent and comply with follow-up requirements

Exclusion Criteria:

* Intracranial hemorrhage within 30 days
* Untreated ruptured intracranial aneurysm
* ≥1 intracranial aneurysm except the target one requires treatment within 6 months
* Immunosuppressive disease
* Active infectious disease (e.g. endocarditis, meningitis)
* Platelet count \< 100 x 103 cells/mm3
* Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.

Primary outcomes:
measure: Procedural success
timeFrame: 5days
measure: ≥50% intracranial aneurysm size reduction success at 6 month
timeFrame: 6months
measure: Aneurysm occlusion success at 6month
timeFrame: 6months
Secondary outcomes:
measure: ≥50% Parent artery stenosis or occlusion
timeFrame: 6months
measure: Newly developed neurological disorder
timeFrame: 6months
measure: Ipsilateral stroke
timeFrame: 6months
measure: 30-day death
timeFrame: 6months
measure: Other adverse events
timeFrame: 6months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Healthcare System, Severance Hospital
state: Yeonsei-ro Seodaemun-gu
Study officials:
affiliation: Yonsei University Healthcare System, Severance Hospital
name: Buyng Moon Kim, PhD. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935467: Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects
Official title: A Study to Characterize the Steady-State Pharmacokinetics and Pharmacodynamics of 2.5 mg Saxagliptin Administered Twice Daily With Meals to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects


Eligibility criteria: Inclusion Criteria:

* Men and women ages 18 to 45 inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]²

Exclusion Criteria:

* WOCBP who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* History of allergy to DPP4 inhibitor or related compounds
* Prior exposure to saxagliptin

Primary outcomes:
measure: Evidence of steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects
timeFrame: Within the first 24 hours of dosing
Secondary outcomes:
measure: To characterize the steady-state pharmacodynamics of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects
timeFrame: 18 time points up to 14 hours on two separate study days
measure: To assess the PK of the pharmacologically active major metabolite of saxagliptin, BMS-510849, following administration of 2.5 mg saxagliptin twice daily with meals to healthy subjects
timeFrame: 21 time points up to 23 hours after first dosing
measure: To assess the safety and tolerability of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects
timeFrame: Day 1 to Day 7
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ppd Development, Lp
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05235867: Secretin in Refeeding
Official title: Secretin Levels in Refeeding-induced Polyuria (Cross Section)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia in Adolescence
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with restrictive-type anorexia hospitalized for medical nutritional stabilization.

Brief summary: Patients with restrictive-type anorexia nervosa who are admitted to the hospital for feeding often urinate excessive amounts. Others have changes in the way that they handle acid and base. These issues prolong hospitalizations. Current data suggest that one hormone--named secretin--may control both urine output and how the body handles acid and base. This study will evaluate whether secretin levels are different in anorexic patients who urinate an excessive amount compared to those who urinate normal amounts. For this study, patients will have one extra blood draw before and after one meal during their hospitalization. The blood draw before the meal coincides with a standard of care blood draw. Also after the meal, subjects will be asked to provide one extra urine sample. Information from subject's medical records will also be used.


Eligibility criteria: Inclusion Criteria:

* Group 1:

  * male and female patients
  * age 13-24 years
  * diagnosis of restrictive-type anorexia nervosa
  * hospitalization for nutritional support
  * \>4 cc/kg/day of urine output (a.k.a. "fluid dumpers"; n=5)
* Group 2:

  * male and female patients
  * age 13-24 years
  * diagnosis of restrictive-type anorexia nervosa
  * hospitalization for nutritional support
  * \<2 cc/kg/d of urine output (a.k.a. "non-dumpers"; n=5)

Exclusion Criteria:

* 5150 hold
* Anti-depressant, anti-psychotic, or anticonvulsant medications
* Previous hospitalization within the past 6 months
* Underlying metabolic disorder not related to anorexia nervosa (including chronic kidney disease, renal tubular disorders, and underlying endocrine disorders)
* Pregnancy
* NG or G-tube feeds after day 2 of hospitalization
* \> 10% of nutritional needs from supplemental feeds

Primary outcomes:
measure: Change in secretin
timeFrame: 1 hour
Secondary outcomes:
measure: Change in serum bicarbonate
timeFrame: 1 hour
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
Study officials:
References:
Clinical trial NCT02724267: Targeted Internal Radiation Therapy in Advanced HCC Patients.
Official title: A Randomized Controlled Prospective Study of Targeted Internal Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internal Radiation
Advanced Hepatocellular Carcinoma
Keywords: 131I-chTNT-1/B treatment
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the 131I-chTNT-1/B treatment effect and safety of individual therapy using randomized controlled study, in order to acquire the evidence of evidence-based medicine and create a new program of targeted internal radiation therapy in advanced HCC patients.


Eligibility criteria: Inclusion Criteria:

1. Via clinical diagnosis and confirm it is advanced hepatocellular carcinoma
2. mRECIST estimation: necrosis region in HCC
3. Negative iodine allergy test
4. Liver function ：Child-Pugh A/B

Exclusion Criteria:

1. reject to attend；
2. impossible to come to our hospital for physical examination regularly.
3. Blood clotting function hindrance; 4, Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
Secondary outcomes:
measure: Time to Progression
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03730467: Puncture Breast Abscess
Official title: Continuation of Breastfeeding After Management of Breast Abscesses by Ultrasound-guided Punctures
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Abscess
Keywords: Breast feeding
breast abscess
ultrasound-guide
puncture
health
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women punctured for a breast lactant abscess in the center of Medical Imaging Duroc

Brief summary: Several breast diseases can complicate breastfeeding : 4% of women develop a mastitis and 1% develop an abscess.

The study deals with cases of breast abscess that have been treated according to a defined protocol (Parisian Perinatal Health Network), by a multidisciplinary team (center of Medical Imaging Duroc) trained in breastfeeding and ultrasound-guided punctures.

The aim of the study is to define the risk factors for the onset of a breast abscess, to evaluate the indications and methods of management of abscess by ultrasound puncture, and to provide arguments motivating the continuation of breastfeeding.


Eligibility criteria: Inclusion Criteria:

* Nursing mothers
* Patients referred for breast abscesses during lactation
* Having an abscess confirmed ultrasoundly and indicating a puncture
* Women punctured of an abscess of the breast abscess in the center of Medical Imaging Duroc
* Not opposing the use of them given and to answer the questionnaire on the immediate and medium-term future by telephone
* Women aged \> 18 years old
* Women understanding French
* Affiliated to Social Security

Exclusion Criteria:

No

Primary outcomes:
measure: Continuation of breastfeeding
timeFrame: 1 week to 6 months after the puncture
Secondary outcomes:
measure: Etiology of the abscess
timeFrame: 1 week to 6 months after the puncture
measure: Adequacy of medical care with the protocol of the Parisian Perinatal Health Network
timeFrame: 1 week to 6 months after the puncture
measure: Relationship between puncture breastfeeding continuation
timeFrame: 1 week to 6 months after the puncture
measure: Relationship between surgery and weaning
timeFrame: 1 week to 6 months after the puncture
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP Hopital Necker Enfants malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Virginie Rigourd, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02442167: Performance of FISH for the Diagnosis of Malignant Biliary Strictures in Thai Patients
Official title: Fluorescence in Situ Hybridization (FISH) Improves Performance of Conventional Cytology for the Diagnosis of Malignant Biliary Tract Strictures in Thai Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Duct Stricture
Malignancy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
First posted: 2015-05-13
Enrollment: 101
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: Patients being evaluated for malignant appearing biliary tract strictures who undergo ERCP

Brief summary: Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators conducted a prospective study in 2 university hospitals to determine diagnostic performance of FISH for the diagnosis of malignant biliary strictures in Thai patients.

Detailed description: Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators aimed to compare the sensitivity of FISH and conventional cytology for the diagnosis of malignant biliary strictures in Thai patients. A prospective study was performed in 2 university hospitals between 2010 and 2013. Patients being evaluated for malignant-appearing biliary strictures were included. Bile duct brushings were collected and assessed by cytology and FISH. Sensitivities with 95% confidence intervals of cytology and FISH were main outcome measurements.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Clinical suspicion of malignant biliary tract strictures

Primary outcomes:
measure: Sensitivities with 95% confidence intervals of FISH
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic, Rochester, MN, USA
name: Lewis R Roberts, MB, ChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04539067: Effect of Controlled Ovarian Stimulation in Quality of Oocyte and Embryo
Official title: Effect of Controlled Ovarian Stimulation With H FSH and HHMg Vs HMG Alone on Oocyte and Embryo Quality in IcsI Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Stimulation
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigate and compare the efficacy of H FSH plus HMG Vs HMG alone on oocyte and embryo quality in IcsI patients

Detailed description: 70 patients divided in to 2groups Group A controlled ovarian stimulation with H FSH and HHMg Group B controlled ovarian stimulation with HMG alone Results will be discussed later

Eligibility criteria: Inclusion Criteria:

1. Infertil women aged from 20_35yr
2. Normal utreus
3. Normal ovaries
4. unexplained infertility
5. no endometriosis

Exclusion Criteria:

1 - poor responders to gonadotropin 2-Prior history of more than 3unsucceful ICSI 3-Any malformation of sexual organs

Primary outcomes:
measure: Comparison between the efficacy of controlled ovarian stimulation with H FSH plus HMG Vs HmG alone on oocyte and embryo quality in IcsI patients
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine, Minia University
name: Marwa Ba Tarahony
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01291667: Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE
Official title: A Phase III Randomized Study for HER2-Overexpressed Metastatic Breast Cancer Patients Treated by Trastuzumab( Cipterbin®) Plus vinorelbinE Simultaneously or Sequencely
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progress-free Survival
Overall Response Rate
Adverse Events
Lead sponsor: Shanghai CP Guojian Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-02-08
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HER2-positive metastatic breast cancer patients

Brief summary: Breast cancer is the most common malignant disease and the most frequent causes of cancer mortality in females worldwide. The situation is same as the world in China. Trastuzumab has been proved valuable treatment for HER2-positive breast cancer patients. Cipterbin® is developing by Shanghai CP Guojian Pharmaceutical Co.Ltd.Now we carried on the phase III trial in order to prove Cipterbin® 's efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* signed ICF
* pathologic diagnosis breast cancer
* HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria age from 18y to 70y KPS\>=70

Exclusion Criteria:

* More than three prior chemotherapy lines for advanced disease LVEF\<50%
* prior exposure vinorebine for breast cancer
* prior exposure Trastuzumab for breast cancer
* uncontrolled brain metastasis
* breastfeeding or pregnant

Primary outcomes:
measure: progress-free survival
Secondary outcomes:
measure: overall response rate,safety
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01177267: Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions(DDI) Among Osteoarthritis Patients
Official title: Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Osteoarthritis Patients Taking Opioid Analgesics and Associated Economic Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: retrospective database analysis in osteoarthritis patients
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: retrospective database analysis

Brief summary: Using a retrospective database analysis, OA patients taking at least one CYP450-metabolized opioid (codeine, fentanyl, hydrocodone, methadone, oxycodone, or tramadol) and at least one other prescription drug metabolized via the CYP450 system were evaluated for an incident drug-drug exposure (DDE), which places them at risk for experiencing a pharmacokinetic drug-drug interaction (DDI).


Eligibility criteria: Inclusion Criteria:

* osteoarthritis

Exclusion Criteria:

* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NEMA Research
name: Joseph Pergolizzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01841567: Post Market Clinical Follow-up Study
Official title: A Multi-centre, Post CE-mark, Open Investigation to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip or Knee Surgery
Keywords: hip
knee
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2013-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall rationale for this study is to evaluate the clinical performance potential for Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less dressing change due to high absorption capacity. This study is a part of Post Market Clinical Follow-Up (PMCF).


Eligibility criteria: Inclusion Criteria

1. Age 45 years
2. Have an expected total length of stay of 4 or more days
3. Undergoing elective primary arthroplasty of the hip or knee
4. Undergoing hip surgery with a standard access
5. Give their written informed consent to participate

Exclusion Criteria

1. Dressing size does not fit the incision area
2. Known allergy hypersensitivity to any of the components of the dressing
3. Multi-trauma
4. Undergoing arthroplasty due to tumour
5. Fractures
6. Wound at the surgical site prior to surgery
7. Neurological deficit of operated side
8. Subject has documented skin disease at time of enrolment, as judged by the investigator
9. Previously enrolled in the present investigation
10. Subject included in other ongoing investigation at present, as judged by the investigator.

Primary outcomes:
measure: Minimize the Risk of the Development of Blistering.
timeFrame: 7 days
Secondary outcomes:
measure: Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.
timeFrame: 7 days
measure: Comfort, Comformability, Acceptability of the Dressing
timeFrame: 7 days
measure: Pain Evaluation
timeFrame: 7 days
measure: Overall Cost Regarding Dressing Wear Time
timeFrame: 7 days
Other outcomes:
Locations:
city: Köln
country: Germany
facility: universitätsklinikum Köln
Study officials:
affiliation: University Hospital Koln
name: Kourosh Zarghooni, Dr. Med
role: PRINCIPAL_INVESTIGATOR
References: