louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03515603: Endocrine Outcome of Surgery for Pituitary Adenoma
Official title: Compare Between Endoscopic and Microsurgical Transsphenoidal Resection of Pituitary Adenomas With Intraoperative MRI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pituitary Adenoma
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized
Primary purpose: TREATMENT

Brief summary: Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI assisted resection of pituitary adenomas.

Detailed description: The main aim of the study is to compare microsurgical and endoscopic transsphenoidal surgery and to determine endocrine outcome. Secondary extent of resection and quality of life will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Suspected symptomatic or progressively growing pituitary adenoma
* Informed consent

Exclusion Criteria:

* Prolactinoma
* No follow-up possible
* Emergency surgery without informed consent or without intraoperative MRI

Primary outcomes:
measure: endocrine function
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Extent of resection
timeFrame: tumor volume before the surgery, 3 months after surgery
measure: Quality of Life, EQ-5D
timeFrame: 3 months and 1 year after surgery
Other outcomes:
Locations:
city: Günzburg
country: Germany
facility: Department of Neurosurgery
Study officials:
affiliation: University Ulm, Department of Neurosurgery
name: Andrej Pala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00165243: Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer
Official title: Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Early-Stage Breast Cancer
Keywords: Axillary Dissection
Tangential Radiation
Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
First posted: 2005-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 55
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 whether treatment to the axilla (area under the arm) can be safely minimized by omitting axillary surgery and full axillary radiation therapy and replacing it with radiation therapy to the breast and lower axilla.

Detailed description: * Patients will have undergone conservative breast surgery without axillary dissection prior to enrollment in this study.
* Patients will receive radiation therapy to the breast, including the lowest axillary lymph nodes, over a period of 6 1/2 weeks.
* No radiation will be specifically directed toward the upper axilla or supraclavicular lymph nodes.
* Patients will also receive 5 years of tamoxifen or another type of hormone therapy determined by the medical oncologist.
* Follow-up visits will occur every 6 months and mammograms every 12 months.

Eligibility criteria: Inclusion Criteria:

* Patients must have clinical stage I or II breast cancer, clinically uninvolved axillary nodes.
* Patients must be 55 years or older.
* Patients must undergo total excision of the primary invasive tumor
* Final pathologic margin status must be negative
* Only estrogen receptor (ER) or progesterone receptor (PR) positive tumors will be permitted

Exclusion Criteria:

* Prior history of malignancy, except for non-melanoma skin cancers and carcinoma in situ fo the cervix

Primary outcomes:
measure: To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.
timeFrame: 5 years
Secondary outcomes:
measure: To determine the safety of this treatment.
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Julia S. Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01207843: Optimized Radiological Diagnosis of Hepatic Candidiasis During the Treatment of Acute Leukemias
Official title: Verbesserung Der Radiologischen Diagnose Von Hepatolienaler Candidiasis während Der Therapie Der Leukämie
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Infection
Keywords: Computed tomography
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-09-23
Enrollment: 88
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with suspected hepatolienal candidiasis.

Brief summary: Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans, but there is no standardized CT protocol for the diagnosis and follow-up of hepatic candidiasis.

The investigators compared the size of the fungal lesions in the chest and abdomen CT. The current analysis aimed to increase the value of CT for the diagnosis and the follow-up of hepatic candidiasis in daily routine.


Eligibility criteria: Inclusion criteria:

* Chest and Abdomen CT with fungal lesion in patients with leukemia

Exclusion criteria:

* Other liver pathologies

Primary outcomes:
measure: The primary end-point was IFI according to the EORTC/MSG 2008 definitions and bacteraemia
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Thomas Frauenfelder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04370743: Evaluation of Infrared Cameras and Non-contact Infrared Thermometers for Measuring Body Temperatures
Official title: Evaluation of Temperature Detecting (Infrared) Cameras and Non-contact (Infrared) Thermometers (NCITs) for Measuring Body Temperatures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Lead sponsor: Food and Drug Administration (FDA)
Sponsor class: FED
Collaborators: name: University of Maryland, College Park
First posted: 2020-05-01
Enrollment: 1125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Human subject above the age of 18

Brief summary: Fever is one of the key symptoms exhibited by contagious patients infected with the Ebola and other viruses. Thermographs and non-contact infrared thermometers (NCITs) are commonly used as early detection tools for screening and isolating sick individuals in healthcare settings and transit centers such as airports. The objective of this clinical study is to evaluate the temperature measurement accuracy of thermographs and NCITs. The study will be accomplished by establishing a protocol based on best practices for screening published in the IEC 80601-2-59:2008 Medical electrical equipment -- Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening standard, performing initial measurements in patients to optimize clinical procedures, then performing quantitative clinical measurements in febrile and afebrile human subjects to compare thermographs - used in accordance with recognized best practices for measurement - with NCITs for fever screening. Since thermographs and NCITs represent the only currently viable mass screening approaches for infectious disease pandemics, like the recent Ebola virus disease (EVD) outbreak in West Africa, the study will evaluate these thermal modalities as medical countermeasures for fever-related pandemics and therefore improve response to these diseases.


Eligibility criteria: Inclusion Criteria:

* Any human subject above the age of 18 that can sit for about 40 minutes with permitted breaks as needed and follow the study instructions can be included.

Exclusion Criteria:

* Human subjects should be free of recent (1 week prior) or current disease affecting the ICR and forehead skin. They should not use topical cosmetics, creams or medications on the face on the day of participation.

Primary outcomes:
measure: Evaluating accuracy of infrared cameras and thermometers for skin temperature measurement
timeFrame: Through study completion, about 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03420443: Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment
Official title: Randomized Clinical Trial of Effects of Synbiotics on Intestinal Microbiota in Patients Undergoing Short-course Preoperative Radiotherapy During Treatment of Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: radiotherapy, probiotics
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate how bacteria and fibre interact with the epithelial cells of the gastrointestinal mucosa to reduce inflammation and to diminish tissue damage caused by radiation therapy to patients diagnosed with rectal cancer.

Detailed description: Thirty patients diagnosed with rectal cancer receiving short term radiation therapy 25 Gray (Gy) during one week preoperatively will be examined. The patients will be divided into three groups with ten patients in each group. One control group without no treatment/study product, one group receiving a test product of 45 g of oat bran and freezing medium only, and one group having a probiotic bacteria, Lactobacillus plantarum HEAL 19 (1010 CFU/g), freezed dried blueberry husks (13 g) and oat bran (22 g), corresponding to 8 g fibre per day in each of the two treated groups. The patients will consume the test product once a day 1 week before and during radiotherapy (2 weeks in total). Mucosal biopsies for microflora analysis and blood samples for analysis of SCFAs and cytokines will be collected at inclusion as well as faecal samples. After radiation therapy, at surgery, blood samples, faecal samples and mucosal biopsies are collected. Fresh faecal samples, blood samples and mucosal biopsies are stored at -80°C until analysis.

Eligibility criteria: Inclusion Criteria:

* Rectal cancer/Adenocarcinoma recti
* Informed Consent explained orally and written, understood, agreed and signed

Exclusion Criteria:

* Diabetes Mellitus
* Inflammatory bowel disease
* Previous radiation to pelvis area
* Ongoing steroid or immunosuppressive therapy
* Ongoing antibiotics therapy

Primary outcomes:
measure: Action of synbiotics on irradiated GI mucosa in rectal cancer treatment
timeFrame: 2 weeks
measure: Action of synbiotics on irradiated GI mucosa in rectal cancer treatment
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Lund, Sweden
name: Bengt Jeppsson, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004343: Study of Hypercortisolism in Cushing's Syndrome and Stress-Induced Pseudo-Cushing's Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cushing's Syndrome
Keywords: Cushing's syndrome
endocrine disorders
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Oregon Health and Science University
First posted: 1999-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES:

I. Determine whether Cushing's syndrome and stress-induced pseudo-Cushing's syndrome can be differentiated by evaluating endogenous corticotropin-releasing hormone activity.

Detailed description: PROTOCOL OUTLINE: Patients undergo a 30-hour infusion of deuterated cortisol with peripheral and petrosal vein measurements of adrenocorticotropin hormone (ACTH) and corticotropin-releasing hormone (CRH). Patients also have a 2-day, low-dose dexamethasone suppression test.

Patients with ACTH tumors are referred for pituitary surgery as indicated. Patients without Cushing's syndrome are entered as controls. During scheduled radiologic procedures, these subjects undergo ACTH and CRH sampling from the petrosal vein or cavernous sinus following a deuterated cortisol infusion.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Suspected adrenocorticotropin hormone (ACTH)-dependent Cushing's syndrome No pregnant women Effective contraception required of fertile women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Mary H. Samuels
role: STUDY_CHAIR
References:
Clinical trial NCT02658643: Analysis of Biliodigestive Anastomosis Techniques (BDA)
Official title: Randomized Controlled Study to Determine the Difference in Time and Complication Rate for Biliodigestive Anastomosis by Continuous Versus Interrupted Suture Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Continuous or Interrupted Suture
Keywords: biliodigestive anastomosis techniques
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2016-01-20
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: The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture.

Detailed description: The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture. A biliodigestive anastomosis is a surgical connection between the common bile duct (ductus choledochus) and the digestive tract to prevent interference of bile flow. Indications for a biliodigestive anastomosis include total or partial resection of the pancreas and duodenum (PPPD, Whipple procedure) for pancreatic tumors, tumors of the biliary tract or duodenum, and biliary tract reconstructions during liver transplantation or advanced liver resections. Furthermore a biliodigestive anastomosis can be required to manage the injury of the biliary tract and infectious and traumatic structures of the biliary tract. Biliodigestive anastomoses can be performed by continuous or interrupted suture. The aim of this study is to determine the difference between continuous and interrupted suture for biliodigestive anastomoses, as advantages and disadvantages of each technique have not been determined. Only patients receiving their first biliodigestive anastomosis will be included.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Scheduled for elective BDA procedure
* Primary BDA procedure
* Diameter of DHC \> 7mm
* Written consent

Exclusion Criteria:

* Previous BDA procedure
* Impaired mental state or language problems
* Lacking compliance
* Emergency procedure

Primary outcomes:
measure: Time to complete the biliodigestive anastomosis
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
Study officials:
affiliation: christoph.reissfelder@uniklinikum-dresden.de
name: Christoph Reißfelder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04310943: Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in Lung Adenocarcinoma
Official title: Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in the Treatment of Advanced Lung Adenocarcinoma: a Single-arm, Phase Ⅱ Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Adenocarcinoma Stage IV
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
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 single arm clinical study is to evaluate the efficacy and safety of Tislelizumab combined with Bevacizumab and albumin paclitaxel in the treatment of advanced lung adenocarcinoma. All of the patients were received EGFR-TKI therapy for 1 line and disease progression. The primary endpoint is six months PFS and safety, the seconday endpoint is ORR and one-year OS rate.

Detailed description: Patients who meet the inclusion criteria will receive Tislelizumab combined with Bevacizumab and albumin paclitaxel for 4 cycles. If there is no disease progression, the patient will continue to receive Tislelizumab maintenance therapy, until the disease progresses or death.

Eligibility criteria: Inclusion Criteria:

* lung adenocarcinoma stage Ⅳ(according AJCC 8)
* received EGFR-TKI for 1 line and disease progression
* EGFR T790M negative
* ECOG PS 0-2

Exclusion Criteria:

* histology of mixed NSCLC with squamous cell carcinoma, neuroendocrine carcinoma and small cell carcinoma.
* have received checkpoint inhibitor.
* uncontrolled pleural effusion, pericardial effusion, or ascites after appropriate intervention
* any unstable systemic disease
* patients who were treated with systemic glucocorticoids (\>10mg/ day prednisone therapeutic dose) or other immunosuppressive drugs within 14 days prior to the initial administration or during the study period

Primary outcomes:
measure: 6m-PFS%
timeFrame: through study completion, an average of 1 year
measure: Safety of Tislelizumab
timeFrame: 30 days after the trial finished
Secondary outcomes:
measure: ORR
timeFrame: one year
measure: OS rate
timeFrame: one year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhou Chengzhi
state: Guangdong
Study officials:
References:
citation: Zitvogel L, Galluzzi L, Smyth MJ, Kroemer G. Mechanism of action of conventional and targeted anticancer therapies: reinstating immunosurveillance. Immunity. 2013 Jul 25;39(1):74-88. doi: 10.1016/j.immuni.2013.06.014.
citation: Wallin JJ, Bendell JC, Funke R, Sznol M, Korski K, Jones S, Hernandez G, Mier J, He X, Hodi FS, Denker M, Leveque V, Canamero M, Babitski G, Koeppen H, Ziai J, Sharma N, Gaire F, Chen DS, Waterkamp D, Hegde PS, McDermott DF. Atezolizumab in combination with bevacizumab enhances antigen-specific T-cell migration in metastatic renal cell carcinoma. Nat Commun. 2016 Aug 30;7:12624. doi: 10.1038/ncomms12624.
Clinical trial NCT02405143: Restoration of Vision After Stroke
Official title: Electrical Stimulation for Restoration of Vision After Stroke in the Damaged Visual Field of Patients With Unilateral Stroke (REVIS Helsinki)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Infarction; Posterior Cerebral Artery
Hemianopsia
Keywords: Controlled clinical trial
Electric Stimulation Therapy
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Academy of Finland
First posted: 2015-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Occipital stroke is associated with homonymous visual field defects (occurring on one side of the visual field). Despite spontaneous recovery, some degree of defect is often permanent. Currently, no treatment exists for such visual field defects.The purpose of this study is to test the efficacy of a type of electrical brain stimulation method, transcranial alternating current stimulation, in reducing these type of visual field defects in their chronic stage.


Eligibility criteria: Inclusion Criteria:

* Occipital ischemic or hemorrhagic stroke 6 months or older
* Hemianopia or quadrantanopia demonstrated by standard automated perimetry
* Visual field defect is stable across baseline
* Presence of residual vision and detectable gradual transition between the the intact and absolutely blind parts of the visual field
* Best corrected visual acuity for at least one eye better or equal to 0.4

Exclusion Criteria:

* Eye or central nervous system disease that interferes with the study
* Cardiac pacemaker
* Other metallic devices or implants precluding participation in MRI scans
* Pregnancy or lactation period
* Epileptic seizures in the past 10 years
* Use of antiepileptic or sedative drugs
* Expected low compliance due to substance abuse
* Known active malignancy

Primary outcomes:
measure: Improved detection in the visual field defined as the percentage change of the stimulus detection rate in High-resolution perimetry (HRP)
timeFrame: Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment
Secondary outcomes:
measure: The change in extent of visual fields in standard automated perimetry
timeFrame: Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Turgut Tatlisumak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: