louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04431791: Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer
Official title: A Single-center，Observational，Ambispective Cohort Study of Regorafenib Versus Fruquintinib in Metastatic Colorectal Cancer Patients Who Have Progressed After at Least Second Lines of Chemotherapies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: Targeted therapy
TTF
OS
PFS
AE
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 268
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with signing the informed consent, would be enrolled when their gastrointestinal physician prescribed to receive regorafenib or fruquintinib after second-line according the condition.

Brief summary: This is an observational, ambispective cohort study. The aim is to compare the efficacy and safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic colorectal cancer patients after second-line therapy will be assigned to receive either regorafenib or fruquintinib, based on decision of the gastrointestinal physician according the patients' condition.


Eligibility criteria: Inclusion Criteria:

1. signed and dated informed consent.
2. Diagnosis of histologically confirmed colorectal cancer, stage IV.
3. after second-line therapy.
4. gastrointestinal physician prescribed to receive regorafenib or fruquintinib according the patients' condition.

Exclusion Criteria:

1. received regorafenib or fruquintinib before third-line therapy.
2. the clinicopathological characteristics and previous therapy were unknown.
3. regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.

Primary outcomes:
measure: Time To Treatment Failure
timeFrame: every month, up to discontinuation of treatment for any reason.
Secondary outcomes:
measure: Overall survival
timeFrame: from enrollment of the first subject until the database cut-off approximately 6 months later.
measure: Progression-free survival
timeFrame: from enrollment of the first subject until the database cut-off approximately 6 months later.
measure: Incidence of adverse events（AEs）
timeFrame: from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04630691: Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients
Official title: Evaluation of Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Implant Complication
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: Institut Straumann AG
First posted: 2020-11-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All

Brief summary: The aim of the present study was to compare the initial healing and long term performance of narrow diameter implants in patients with uncontrolled Diabetes mellitus type 2 (T2DM) and healthy individuals.


Eligibility criteria: Inclusion criteria:

Patients with one or more missing teeth posterior to the canine either in the maxilla or mandible and associated with diminished alveolar ridge dimensions were included in the study

Exclusion Criteria:

* immobility of diabetic patients
* periodontal surgery and/or antibiotic therapy within the last 6 months prior to baseline
* pregnancy and lactation period
* Full Mouth Plaque Score (FMPS) \> 25%
* untreated periodontitis
* smoking \> 10 cigarettes/day
* insufficient crestal volume making an augmentation procedure necessary
* previously performed ridge augmentation procedure for a staged implant placement
* permanent medication potentially affecting blood perfusion rate and bone metabolism

Primary outcomes:
measure: No difference
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Diehl D, Kaner D, Bockholt A, Bilhan H, Friedmann A. Microcirculation and neutrophil-related cytokine concentrations are not altered around narrow diameter implants in T2DM patients during wound healing. Clin Oral Investig. 2023 Mar;27(3):1167-1175. doi: 10.1007/s00784-022-04731-3. Epub 2022 Oct 13.
citation: Friedmann A, Winkler M, Diehl D, Yildiz MS, Bilhan H. One-year performance of posterior narrow diameter implants in hyperglycemic and normo-glycemic patients-a pilot study. Clin Oral Investig. 2021 Dec;25(12):6707-6715. doi: 10.1007/s00784-021-03957-x. Epub 2021 May 3.
Clinical trial NCT05088291: Application of a New X-ray Protective Device in Coronary Interventional Therapy
Official title: Effectiveness of a New X-ray Protection Devices in Reducing Radiation in Coronary Intervention Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: cardiology
coronary angiography
coronary angioplasty
percutaneous coronary intervention
radiation
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: The First People's Hospital of Lianyungang
First posted: 2021-10-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for CAG or PCI were successively included in the First Affiliated Hospital of Nanjing Medical University and The First People's Hospital of Lianyungang.

Brief summary: This is a multi-center, prospective and controlled clinical trial which will enroll 200 coronary arteriography or percutaneous coronary intervention with 2-4 interventional cardiologist. The interventional cardiologist performed 100 interventional procedures using either a new protective device (NPD) or a traditional lead clothing (TLC). The cumulative dose outside the NPD or TLC and the first operator at each height (110cm, 90cm, 50cm, 10cm) was measured. The main indicators of the study are the average X-ray shielding efficiency of the NPD and the TLC at four different heights. The investigators will record all operation information in this study.

Detailed description: In this study, the investigators developed a new protection device (NPD) and compared its effects on the reduction of radiation exposure compared with the traditional lead clothing (TLC).

The NPD (WLXP-006, Yingnuoweite Medical Science and Technology, Co., Ltd., Nanjing, China) is a floor-standing medical radiation protection device mainly composed of a barrel-like frame and protective lead rubber (0.5 mm lead equivalent).

Eligibility criteria: Inclusion Criteria:

* Consecutive patients were admitted to the group for coronary arteriography (CAG) or percutaneous coronary intervention (PCI).

Exclusion Criteria:

* There were no exclusion criteria, and the patients were continuously enrolled for interventional diagnosis and treatment.

Primary outcomes:
measure: The cumulative absorbed dose at different heights outside the NPD
timeFrame: After study completion, about 6 months
measure: The cumulative absorbed dose at different heights outside the TLC
timeFrame: After study completion, about 6 months
measure: The cumulative absorbed dose of the first operator
timeFrame: After study completion, about 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Chunjian Li, Dr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02570191: A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)
Official title: An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult participants 18-70 years of age
* Positive test result for HBsAg for \>6 months
* Naive to treatment for HBV
* On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis

Exclusion Criteria:

* Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
* Decompensated liver disease
* Hepatocellular cancer
* Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
* Medical condition associated with chronic liver disease

Primary outcomes:
measure: Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up
timeFrame: 72 Weeks
measure: Alanine Transaminase (ALT) Normalization at the End of Follow-Up
timeFrame: 72 Weeks
Secondary outcomes:
measure: Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up
timeFrame: 72 Weeks
measure: Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up
timeFrame: 72 Weeks
measure: HBV DNA Suppression <20000 Copies/mL at the End of Treatment
timeFrame: 48 Weeks
measure: Alanine Transaminase (ALT) Normalization at the End of Treatment
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT02881294: A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
Official title: A Phase I, Single-center, Open-label, Single-dose Study to Evaluate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of Orally Administered SUVN-G3031 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognitive Disorders
Lead sponsor: Suven Life Sciences Limited
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male or female aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive) for food and gender effect
* Healthy male aged 60 to 70 years with a BMI between 18 and 32 kg/m2, (inclusive) for age effect

Exclusion Criteria:

* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study drug.
* Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody
* History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.

Primary outcomes:
measure: Area under concentration (AUC)
timeFrame: 96 hours
measure: Maximum observed concentration (Cmax)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Quintiles
state: Kansas
Study officials:
References:
Clinical trial NCT05656794: Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer
Official title: Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Metastases
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Histologically-proven metastatic prostate cancer
* Presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.)
* Planned to or receiving systemic treatment ADT +/- ARAT as per physician discretion (Previous chemotherapy allowed if completed more than 6 weeks prior to randomization.)
* Planned for EBRT
* ECOG 0 or 1
* Age 18 years or older

Exclusion Criteria:

* Prior radiotherapy to pelvis
* Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
* Any condition where radiotherapy is contraindicated

Primary outcomes:
measure: Rates of acute toxicity
timeFrame: 5 years
Secondary outcomes:
measure: Rates of late toxicity.
timeFrame: 5 years
measure: Measure failure-free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT00910494: Intraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System
Official title: Intraoperative Radiotherapy (IORT) for Rectal Cancer Using the Photon Radiosurgery System (PRS): A Phase I Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Neoplasm
Keywords: Rectal neoplasm C04.588.274.476.411.307.790
Intraoperative Radiotherapy
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2009-06-01
Enrollment: 9
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: The investigators would like to test the safety and efficacy of intraoperative radiotherapy (IORT) in rectal cancer using the Photon Radiosurgery System (PRS).

Detailed description: Rectal cancer is usually managed by a combination of surgery and x-ray treatments (radiotherapy). The standard way of delivering radiotherapy is with external 'beams' directed at the tumour site. However, although in rectal cancer these treatments are effective, patients are often troubled by late side effects. An alternative option is to deliver the x-rays at the same time as surgery. This is known as intraoperative radiotherapy, or IORT, and a number of techniques have already been tried. There is a new IORT technology known as the Photon Radiosurgery System (PRS) which we are using to treat breast and brain cancers. Our experience to date has informed us that IORT with this x-ray source is safe and effective. We would like to use the technology to treat rectal cancer and believe that it may improve disease outcomes without the side effects associated with standard radiotherapy. We would also like to study the biological processes that follow radiation. It is not understood why some people are more sensitive to x-ray treatments than others. If we knew the reasons for this then we might be able to individualise treatments.

Eligibility criteria: Inclusion Criteria:

* Operable rectal cancer

Exclusion Criteria:

* Locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease

Primary outcomes:
measure: surgical complication rate
timeFrame: 30 days post treatment
Secondary outcomes:
measure: survival
timeFrame: 5 year
measure: local control
timeFrame: 5 year
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: University of Dundee
state: Tayside
Study officials:
affiliation: University of Dundee
name: Alastair Munro, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01886794: Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
Official title: Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pelvic Floor Disorders
Keywords: pelvic floor dysfunction
pelvic organ prolapse
vaginal estrogen effects
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 10
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.

Detailed description: Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments. We will perform in vivo evaluations with colposcopy and OCT to determine epithelial thickness and overall mucosal health prior to surgery. At the time of surgery, we will obtain tissue for histologic and imaging analysis.

Eligibility criteria: Inclusion Criteria:

* 21 to 70 years of age
* Stage II or greater pelvic organ prolapse (POP)
* Individuals electing surgery to treat their POP
* Willing and able to comply with study procedures
* Willing and able to provide written informed consent

Exclusion Criteria:

* Contraindication for estrogen cream
* Any medical condition that in the opinion of the investigator would place the subject at increased risk for participation
* History of connective tissue disease
* Previous hysterectomy or pelvic organ prolapse surgery
* Known allergic reaction to any agent required by the protocol
* Use of hormone therapy in postmenopausal women in the last 90 days
* Pregnant or lactating females
* History of prior noncompliance or the presence or history of psychiatric condition that would in the opinion of the investigator make it difficult for the subject to comply with study procedures or follow instructions

Primary outcomes:
measure: Vaginal epithelial thickness
timeFrame: 1-month perioperative study
Secondary outcomes:
measure: Histologic assessment of excised tissue
timeFrame: 1-month perioperative study
Other outcomes:
Locations:
city: Galveston
country: United States
facility: UTMB Galveston
state: Texas
Study officials:
affiliation: UTMB Galveston
name: Kathleen Vincent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01374594: Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2011-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects and type 2 diabetes patients (T2DM)

Brief summary: PURPOSE

The goal of the present project is to unravel the importance of bile acid-induced GLP-1 secretion (via the G protein-coupled receptor TGR5) in human physiology.

In the present study the investigators examine the GLP-1 secretion in healthy subjects and in Type 2 Diabetes Mellitus (T2DM) patients. The investigators hypothesize that patients with T2DM of relatively long duration will be characterized by reduced gall bladder emptying, and, consequently, reduced intestinal TGR5 activation; resulting in attenuated postprandial GLP-1 responses (primary endpoint).


Eligibility criteria: Inclusion Criteria: (Healthy)

* HbA1 \< 6 %
* Normal haemoglobin levels
* Informed content

Inclusion Criteria: (T2DM)

* T2DM \> 5 years
* Normal haemoglobin levels
* Informed content

Exclusion Criteria: (T2DM)

* Treatment with insulin, DPP-IV inhibitor or GLP-1 analogues
* Obesity (BMI \> 30)
* Age \> 70 years
* Gastrointestinal disease
* Nephropathy
* Liver disease
* Medication which cannot be on hold for 12h
* Gastrointestinal surgery

Exclusion Criteria: (Healthy)

* 1st degree relatives with diabetes
* Obesity (BMI \> 30)
* Age \> 70 years
* Gastrointestinal disease
* Nephropathy
* Liver disease
* Medication which cannot be on hold for 12h
* Gastrointestinal surgery

Primary outcomes:
measure: GLP-1 secretion
timeFrame: Postprandial
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
Study officials:
References:
citation: Sonne DP, van Nierop FS, Kulik W, Soeters MR, Vilsboll T, Knop FK. Postprandial Plasma Concentrations of Individual Bile Acids and FGF-19 in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Aug;101(8):3002-9. doi: 10.1210/jc.2016-1607. Epub 2016 Jun 7.
citation: Sonne DP, Vilsboll T, Knop FK. Pancreatic Amylase and Lipase Plasma Concentrations Are Unaffected by Increments in Endogenous GLP-1 Levels Following Liquid Meal Tests. Diabetes Care. 2015 May;38(5):e71-2. doi: 10.2337/dc14-2751. No abstract available.