louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00569140: A Phase 1, Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration
Official title: A Phase 1, Single Ascending Dose Trial to Establish the Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Monotherapy and of E10030 Given in Combination With Lucentis®0.5 Mg/Eye in Subjects With Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age-related Macular Degeneration
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis® 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

Subfoveal choroidal neovascularization (CNV) due to AMD

Exclusion Criteria:

* Any of the following underlying diseases including:

  * Diabetic retinopathy.
  * History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months, ventricular tachyarrythmias requiring ongoing treatment.
  * History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
  * Clinically significant impaired renal (serum creatinine \>2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function.
  * Stroke (within 12 months of trial entry).
  * Any major surgical procedure within one month of trial entry. Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition.

Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the E10030 formulation.

Primary outcomes:
measure: Ophthalmic DLTs
timeFrame: immediate
Secondary outcomes:
measure: adverse events
timeFrame: immendiate
Other outcomes:
Locations:
city: New York
country: United States
facility: Denise Teuber
state: New York
Study officials:
References:
Clinical trial NCT00397540: The Effect of Viral Load on Intrahepatic Recurrence in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC)
Official title: Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Chronic Hepatitis B
Keywords: HBV DNA
HCC
recurrence
PEIT
RFTA
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2006-11-09
Enrollment: 145
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs) related with HBV.

Detailed description: Prospective cohort study

Survival

* Overall survival rate
* Disease free survival rate

Recurrence

* Cumulative recurrence rate

Eligibility criteria: Inclusion Criteria:

* Child-Pugh Class A or B
* Maximal tumor size less than 5 cm
* No previous history of treatment for hepatocellular carcinoma
* Recurrent hepatocellular carcinoma located more than 2 cm from the previous cancer site and is found more than 1 year's gap

Exclusion Criteria:

* Hepatocellular carcinoma in portal vein
* Hepatocellular carcinoma in hepatic vein

Primary outcomes:
measure: 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)
timeFrame: 1,3,5 year
Secondary outcomes:
measure: Overall Survival
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Won Kim, Professor
role: STUDY_DIRECTOR
References:
citation: Seo JY, Kim W, Kwon JH, Jin EH, Yu SJ, Kim HY, Jung YJ, Kim D, Kim YJ, Yoon JH, Lee HS. Noninvasive fibrosis indices predict intrahepatic distant recurrence of hepatitis B-related hepatocellular carcinoma following radiofrequency ablation. Liver Int. 2013 Jul;33(6):884-93. doi: 10.1111/liv.12132. Epub 2013 Mar 5.
citation: Chung GE, Kim W, Lee JH, Kim YJ, Yoon JH, Lee JM, Lee JY, Kim SH, Kim D, Lee HS. Negative hepatitis B envelope antigen predicts intrahepatic recurrence in hepatitis B virus-related hepatocellular carcinoma after ablation therapy. J Gastroenterol Hepatol. 2011 Nov;26(11):1638-45. doi: 10.1111/j.1440-1746.2011.06777.x.
Clinical trial NCT05071040: Sarcopenia and Physical Activity Intervention: a Randomized-controlled Trial
Official title: Reduction of Sarcopenia Through a Home-based, App-monitored, Physical Exercise Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
Collaborators: name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
First posted: 2021-10-07
Enrollment: 198
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sarcopenia is a pathophysiological process associated with aging and some metabolic conditions characterized by progressive muscle tissue loss, which may lead to loss of strength and performance and increased risk of falls and fractures, physical disability and premature death. With the present project the investigator aim to assess the effect of a feasible exercise program to improve muscle strength (primary outcome), and muscle volume and performance and other measures potentially associated with sarcopenia (secondary outcomes) in elderly and people living with HIV (PLWH) with sarcopenia. The investigators plan to enroll 98 elderly and 98 PLWH in a multicentric, 48-week, randomized, parallel-group, open label, superiority trial comparing the effect of a home-based and app-monitored strength exercise intervention versus no intervention. The investigators expect that participants who exercise will improve strength and other parameters and that improvement at week 12 and week 48 will be higher than in no-exercise controls.


Eligibility criteria: Inclusion Criteria:

* Sedentary
* \>60 year-old in the elderly group or \>50 year-old for the PLWH group;
* with sarcopenia, as defined by both relative loss of muscle mass by bioimpedentiometry (BIA) and low muscle strength by handgrip

Exclusion Criteria:

* Any disease requiring hospitalization in the 6 weeks before enrollment;
* Medical conditions contraindicating the proposed exercise as established by a sport medicine specialist;
* Current substance or alcohol abuse or use of drugs that may influence balance and coordination;
* Not being able to walk without assistance and to perform the prescribed exercises as by protocol.

Primary outcomes:
measure: Muscle strenght improvement
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele Turro
Study officials:
References:
Clinical trial NCT06250140: Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids
Official title: A Multicenter Retrospective Study on the Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Internal Hemorrhoid
Lead sponsor: Shenzhen Hospital of Southern Medical University
Sponsor class: OTHER
Collaborators: name: 964 hospital of joint Logistics Support Force
name: The Chinese people's liberation army army medical center
First posted: 2024-02-08
Enrollment: 900
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: Patients with internal hemorrhoids who had undergone endoscopic treatment for internal hemorrhoids could be enrolled in the study after informed consent was obtained

Brief summary: 2.1 Main objective: To observe the short-term and long-term recurrence rates of various endoscopic minimally invasive treatment methods for internal hemorrhoids and different time points of endoscopic minimally invasive treatment for internal hemorrhoids in patients with grade I-III internal hemorrhoids

2.2 Secondary objective: To observe the safety and efficacy of endoscopic minimally invasive treatment of internal hemorrhoids


Eligibility criteria: Inclusion Criteria:

* 1. Age ≥18 years old, both sexes

  2, grade I-III internal hemorrhoids with symptoms related to internal hemorrhoids

  3. The purpose and adverse consequences of endoscopic minimally invasive treatment of internal hemorrhoids have been fully understood before surgery, and the informed consent for endoscopic minimally invasive treatment of internal hemorrhoids has been signed

Exclusion Criteria:

* 1. Patients with contraindications to endoscopic minimally invasive treatment (1) grade IV internal hemorrhoids, mixed hemorrhoids and external hemorrhoids; (2) I-III

Degree of internal hemorrhoids with incarceration, thrombosis, erosion, infection, etc. (3) patients with severe systemic diseases could not tolerate endoscopic treatment; (4) accompanied by crissum infectious disease, anal fistula, and inflammatory bowel disease activity, etc.; (5) in menstrual period, pregnancy and puerperium, (6) patients with sclerotherapy allergy; (7) function of blood coagulation disorder or are using anticoagulant drugs.

2. Patients with a history of allergy to narcotic drugs

3. Patients who were deemed by the investigator to be ineligible for participation in the trial

Primary outcomes:
measure: Recurrence rate of minimally invasive endoscopic treatment
timeFrame: One year
Secondary outcomes:
measure: The overall efficacy of various treatment methods
timeFrame: One year
measure: Recurrence rates of various treatment modalities in different grades
timeFrame: One year
measure: The efficacy of sequential treatment after recurrence was evaluated
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03143140: The Effect of Percutaneous Radiofrequency Ablation of Feeding Arterial for Hepatocellular Carcinoma
Official title: The Clinical Value of Percutaneous Radiofrequency Ablation of Feeding Arterial for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Neoplasms
Keywords: Ablation Techniques
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 120
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: To evaluate a novel technique-ultrasound guided percutaneous abaltion of tumor feeding artery before RFA for liver malignancy.

Detailed description: Hepatocellular carcinoma is one of the most common tumor in clinical practice. In recent years, various local therapies, especially radiofrequency ablation (RFA) has been proved safe and effective.The main limitation of RFA is that its therapeutic impact is significant compromised by blood flow cooling effect, especially in hypervascular HCC. Recent studies showed combined therapy of TACE and RFA can decrease the blood supply of tumor, increase ablated volume and therefore improve the outcome. However, TACE application is limited in patients who cannot tolerate this therapy due to the side effects of repeated TACE, poor liver function or previously legated hepatic artery. The present study is focus on "difficult-to-treat" HCC patients who are neither surgical candidates, nor TACE candidates. The investigators introduce the novel treatment mode that RFA followed ultrasound guided percutaneous ablation of tumur feeding arterial to treat these difficult cases and evaluate the clinical effect.

Eligibility criteria: Inclusion Criteria:

1. tumor number ≤3， maximum tumor size ≤5cm;
2. accessibility of tumors via a percutaneous approach;
3. tumor feeding artery can be detected by 3D contrast enhance ultrasound;
4. platelet count ≥ 50,000/ml and INR \<1.6;
5. life expectancy more than 6 months
6. Child grade A or B

Exclusion Criteria:

1. patients who scheduled liver transplantation
2. with extrahepatic metastasis
3. women during menstruation, pregnancy, child birth and baby nursing period
4. patients with severe mental disorder
5. cardiopulmonary failure

Primary outcomes:
measure: completed tumor necrosis
timeFrame: 1 month
Secondary outcomes:
measure: tumor recurrence
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Kun Yan, master
role: STUDY_DIRECTOR
References:
citation: Zhang ZY, Lee JC, Yang W, Yan K, Wu W, Wang YJ, Chen MH. Percutaneous ablation of the tumor feeding artery for hypervascular hepatocellular carcinoma before tumor ablation. Int J Hyperthermia. 2018;35(1):133-139. doi: 10.1080/02656736.2018.1484525. Epub 2018 Jul 12.
Clinical trial NCT04777240: Characterization of Enterococci
Official title: Characterization of Enterococci; Distribution of Virulence Markers, Virulence Genes and Antibiotic Resistance Pattern of the Isolated Species
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Samples From Patients With Enterococcal Infections
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients in ICU in Sohag University Hospital

Brief summary: Study on Characterization of Enterococci because nowadays it become an important cause of nosocomial infections .detection of the most common two species of Enterococci and most common virulence factors \& its genes with determination of antibiotics sensitivity test for the isolated strains


Eligibility criteria: Inclusion Criteria:

* any patients in ICU has manifestations of urinary tract infections, surgical wound infections, intra-abdominal infections, intrapelvic infections, bacteraemia and infective endocarditis

Exclusion Criteria:

* patients receiving antibiotics in previous 48 hours

Primary outcomes:
measure: I) Sample collection
timeFrame: 2 months
measure: II) Identification of Enterococci:
timeFrame: 2 month
measure: III) Phenotypic detection of virulence marker of Enterococci(Gelatinase activity)
timeFrame: 2 weeks
measure: IV)Phenotypic detection of virulence marker of Enterococci (hemolytic activity)
timeFrame: 1 week
measure: V) Phenotypic detection of virulence marker of Enterococci(Caseinase production)
timeFrame: 2 weeks
measure: VI) Phenotypic detection of virulence marker of Enterococci(Formation of Slime layer)
timeFrame: 1 week
measure: VII) Phenotypic detection of virulence marker of EnterococcI (Biofilm formation)
timeFrame: 2 weeks
measure: VIII) Antibiotic sensitivity test:
timeFrame: 3 monthe
measure: IX) Molecular Identification of commonest Enterococcus species
timeFrame: 1 month
measure: X) Molecular detection of virulence genes
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
affiliation: Sohag Faculty of Medicine
name: Ekram Ab Rahmand Mahmoud, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06888440: Zinc Stents for the Treatment of Gingivitis
Official title: Clinical Effects of Zinc-containing Stents on Gingivitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis; Chronic
Keywords: gingivitis
zinc
treatment
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background This study investigates the effects of zinc-containing stents on gingival inflammation, bleeding, and plaque regrowth in gingivitis patients.

Methods A randomized, double-blind, placebo-controlled study was conducted at Çukurova University, enrolling 42 systemically healthy gingivitis patients aged 18-30. Participants were assigned to either a test group (zinc-containing stents) or a control group (placebo stents) and instructed to wear their stents for at least 12 hours daily for four weeks. Clinical measurements, including Gingival Index (GI), Plaque Index (PI), and Bleeding on Probing (BOP), were assessed at baseline, and at the 2nd, 4th, and 8th weeks. Statistical analysis was performed using IBM SPSS and RStudio.


Eligibility criteria: Inclusion Criteria:

* Presence of plaque-induced gingivitis \[bleeding on gentle probing at \>30% of sites examined and a gingival index (GI) of at least 1 at \>60% of sites examined\],
* Plaque index (PI) of ≥ 2 according to the modified Quigley\&Hein index,
* 18-30 years old,
* At least 20 natural teeth,
* Systemically healthy.

Exclusion Criteria:

* Pocket probing depth (PPD) of ≥4 mm,
* Interdental clinical attachment loss (CAL) detectable at ≥2 nonadjacent teeth or displaying buccal/oral CAL ≥3 mm coupled with PD ≥3 mm
* Subjects with a history of allergies to Zinc,
* The presence of hematologic disorders or any other systemic illness,
* Pregnancy and breastfeeding,
* Current orthodontic treatment,
* History of periodontal therapy,
* Use of antibiotics or anti-inflammatory medication within the preceding 6 months,
* Smoking.

Primary outcomes:
measure: Gingival index
timeFrame: Baseline, 2nd week, 4th week, 8th week
Secondary outcomes:
measure: Plaque index
timeFrame: Baseline, 2nd week, 4th week, 8th week
measure: Bleeding on probing
timeFrame: Baseline, 2nd week, 4th week, 8th week
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Faculty of Dentistry
Study officials:
affiliation: Cukurova University
name: Mehmet Cenk Haytac, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06798740: Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices
Official title: Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Brain Aneurysm
Keywords: clip
sugita
Lead sponsor: Mizuho Corporation
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 150
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: Subjects who have an intracranial aneurysm (ruptured or unruptured) that the physician intends to treat with the subject device(s)

Brief summary: The objective of this study is to verify the performance and safety of the Sugita Aneurysm Clips devices when used as intended and to identify possible risk factors. Data collected will be used to support the continuing performance and safety of the devices in the post-market use environment in Europe. Subjects who have an intracranial aneurysm that the physician intends to treat with the subject devices will be included in the study. Subjects will be followup as per hospital standard of care for 5 years.


Eligibility criteria: Inclusion Criteria:

* Subject has an intracranial aneurysm (ruptured or unruptured) that can be treated with one of the proposed devices.
* Subject is adult, ≥18 years.
* As per national regulations, subject or subject's legally authorized representative (LAR) has signed written informed consent.
* Subject is willing to comply with scheduled visits and examinations per institutional standard of care.

Exclusion Criteria:

* Subject is currently enrolled in or plans to be enrolled in a concurrent drug or device randomized study.
* Subject has a condition which will not allow him/her to comply with his/her post-procedure follow up per the institutional standard of care (medical condition, subject living abroad and unable to return for follow- up, e.g.).
* Subject does not meet IFU criteria of the subject device.
* Subject is a child, \<18 years.

Primary outcomes:
measure: Permanent aneurysm occlusion
timeFrame: Up to 12 months
Secondary outcomes:
measure: Adverse events
timeFrame: up to 60 months
measure: mRS
timeFrame: through 60 months
measure: Aneurysm retreatment
timeFrame: through 60 months
measure: Procedure success
timeFrame: within 1 week after clipping
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Universitätsklinikum Essen
Study officials:
References:
Clinical trial NCT05081440: A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center
Official title: A Multi-center, Prospective, Observational Study to Describe the siTuation of Blood Lipid mAnagement Among the Population With hypeRtension and/or Type 2 diabeTes in Community Health Center(START-CHC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lipoprotein Disorder
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2021-10-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5000 patients with hypeRtension and/or type 2 diabeTes inCommunity Health Center

Brief summary: A multi-center, prospective, observational Study to describe the siTuation of blood lipid mAnagement among the population with hypeRtension and/or type 2 diabeTes in Community Health Center


Eligibility criteria: Inclusion Criteria:

1. The informed consent form (ICF) should be signed before conducting any research-related operations
2. Age ≥18 years
3. Patients with well-diagnosed hypertension (HTN) and/or type 2 diabetes (T2DM) and have been ill for ≥ 3 months
4. The patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded

Exclusion Criteria:

1.Patients with well-diagnosed atherosclerotic cardiovascular disease (ASCVD) 2. Have received any form of lipid-lowering treatment within 4 weeks before the screening period 3. The patient is currently participating in any other clinical trial except this study

-

Primary outcomes:
measure: primary outcome
timeFrame: 2022.12.01
Secondary outcomes:
measure: secondary outcome
timeFrame: 2022.12.01
Other outcomes:
Locations:
Study officials:
References: